subslover
2週前
DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study
Châtillon, France, January 8th, 2025
DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study
EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months
68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12
No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE
DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company’s proposed labeling approach shared with FDA
DBV to highlight these data in multiple abstract presentations at the Eastern Food Allergy & Comorbidity Conference, January 9-12, in Palm Beach, Florida
Company to host investor webcast today at 5:00pm ET
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive twenty-four month results from its Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of VIASKIN® peanut 250 µg [VP250] in toddlers ages 1 to 3 years). The data provide support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters.
DBV also announced today new Viaskin Peanut Patch efficacy and safety data based on average daily wear time from the EPITOPE study that is supportive of the Company’s VIASKIN peanut labeling strategy, proposed to FDA in June 2024. This post-hoc analysis identified subjects on Viaskin Peanut with low or high day-to-day variability in daily wear time during the first 90 days on treatment – a highly predictive marker of the average daily wear time (ADWT) during the course of the 12-month study. Subjects with low day-to-day variability in daily wear time had higher ADWT which correlated with a more robust efficacy response at 12 months.
These data are being presented in multiple poster presentations at the Eastern Food Allergy & Comorbidity Conference, which is being held January 9th through 12th, 2025, in Palm Beach, Florida.
Twenty-Four Month EPITOPE OLE Results
After completing participation (12 months) in the EPITOPE study, eligible subjects could enroll in the OLE to receive a total of 36 months of VIASKIN peanut treatment. Double-blind placebo-controlled food challenges (DBPCFC) were conducted at the end of each year of treatment with safety assessed throughout the entire OLE. Importantly, all subjects remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment.
In the EPITOPE OLE, VIASKIN Peanut data suggests further improvement through 36 months of treatment across all efficacy parameters. Key data highlights include:
266 EPITOPE participants enrolled in the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62 placebo). After three years of VP250, 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study). A similar increase was observed for participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at month 12;).Those completing the DBPCFC without meeting stopping criteria increased to 68.2% at month 36 from 30.7% at month 12.
Continued reductions in DBPCFC reaction severity occurred, with 66.5% having no/mild symptoms at month 36 vs 40.2% at month 12.
No treatment-related anaphylaxis or serious treatment-related TEAEs occurred in Year 3. Local application-site reactions occurred less frequently in Year 3 vs Years 1 and 2.
In placebo-treated EPITOPE participants, outcomes after 24 months of VP250 in the OLE were consistent with 24-month results in EPITOPE VP250 participants.
“The compelling results from 36 months of Viaskin Peanut treatment demonstrate a continuation of the very positive efficacy and safety trends that have been previously observed in this study,” said Pharis Mohideen, Chief Medical Officer, DBV Technologies. “Notably, the data indicates that continued treatment with VIASKIN Peanut resulted in further improvement across all efficacy parameters in the second year of the OLE with no new safety signals. The data show that more than two-thirds of subjects completed the food challenge without meeting pre-defined stopping criteria, consuming the equivalent of 12-14 peanut kernels, and more than 83% reached an ED of ≥1,000mg, or the equivalent of 3-4 peanut kernels. Recall that this is a patient population that can experience devastating consequences from accidental exposure to just fractions of a peanut kernel. As we prepare to initiate the COMFORT Toddlers supplemental safety study, one of the final steps to support a BLA submission, these results remind us of the tremendous potential of VIASKIN Peanut as a game changer for the peanut allergy community.”
Shared decision making for best response based on patch wear experience.
DBV also announced today new data from the Phase 3 EPITOPE study that supports the labeling approach that was proposed to FDA in June 2024. Patch wear time assessed daily by caregivers was averaged (i.e., average daily wear time or ADWT) for each subject for the first 90 days of treatment (excluding treatment initiation Days 1-28) and over the 12-month EPITOPE study.
Baseline markers of atopic disease severity such as peanut-specific IgE, skin prick test wheal size, SCORAD scores (measure of atopic dermatitis) and eliciting dose were similar between subjects with ADWT ≥ 20 hours/day and < 20 hours/day. The incidence rates and severity of local application site reactions and use of corticosteroids were also similar between groups, but the participants with ADWT < 20 hours reported markedly more scratching as a reason for patch detachments. This strongly suggests that these participants experienced lower tolerability (i.e., higher degree of “itchiness”) to peanut-induced local skin immune responses.
Data suggests that subjects with low day-to-day wear time variability (≥ 20 hours/day ADWT) had a more robust efficacy response relative to the high day-to-day variability (
subslover
1月前
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
Châtillon, France, December 11th, 2024
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis
COMFORT Toddlers study on-track to initiate in 2Q 2025
Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026
FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old
Company to host investor webcast today at 5:00pm ET
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study.
“DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22nd press release announcing details in support of our separate Viaskin Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in Europe,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible.”
Accelerated Approval Pathway
The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria:
That the product candidate treats a serious condition
That the product candidate generally provides a meaningful advantage over available therapies
That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit
As DBV previously announced, FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two.
FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company’s Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval.
In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient’s skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location.
Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study.
Post-Marketing Confirmatory Study
In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted.
To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial.
The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study. Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study. The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling.
“When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). “I’m pleased to learn that DBV’s constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider.”
COMFORT Toddlers Supplemental Safety Study
COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study.
“I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study,” stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. “Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial.”
The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 – 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers.
As previously disclosed, DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA:
FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint.
Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety).
The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data.
DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.
Biologic License Application Submission in 1 – 3 Year-Olds
There will be two Phase 3 studies in 1 – 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission:
Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine in May 2023), and 36 months of open-label extension data.
Six months of DBPC data generated in COMFORT Toddlers supplemental safety study.
DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026.
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, Wednesday, December 11th, at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
United States: +1-877-346-6112
International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age)
subslover
3月前
DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe
Châtillon, France, October 22, 2024
DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe
DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old
BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025
VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4Q 2025
European Medicines Agency (EMA) scientific advice confirms registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1 – 7 year-old indication in Europe
Company to host investor conference call at 5:00pm ET today
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to guidance provided by the U.S. Food and Drug Administration (FDA) on a pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the EMA on a 1 – 7 year-old indication in Europe. DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request.
“Our agreement with FDA guidance on a path towards Accelerated Approval for the Viaskin Peanut patch in 1 – 3 year-olds represents a significant step forward in getting this novel treatment to patients,” said Daniel Tasse, Chief Executive Officer, DBV Technologies. “I am pleased that the FDA recognizes the urgent unmet medical need that exists for this young patient population. We are also very pleased with the scientific advice received from EMA – one patch in peanut allergic children in 1 – 7 year-olds, subject to a safety study with our modified patch in toddlers 1 – 3 years-old.”
Viaskin Peanut Patch in Toddlers 1 – 3 Years
Accelerated Approval Pathway
FDA guidance for Accelerated Approval include three qualifying criteria: 1) that the product treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. DBV intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. DBV expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.
COMFORT Toddlers
DBV is pleased to have aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 - 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance.
With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 year-olds under the Accelerated Approval program is anticipated to be supported by:
Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and
Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in 2Q 2025.
“DBV’s Viaskin Peanut patch has the potential to significantly improve the lives of peanut allergic toddlers and their caregivers,” stated Dr. David Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children’s Hospital Colorado. “With few approved treatment options for this patient population – the age range in which most young people are initially diagnosed with peanut allergy – the Viaskin Peanut patch has the potential to be a game changer in the food allergy community, and I look forward to having the opportunity to incorporate it into my own practice, if approved.”
Post-Marketing Confirmatory Study
DBV and FDA are in general agreement that the confirmatory study will need to demonstrate the effectiveness of the Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. DBV will prioritize initiation of the COMFORT Toddlers safety study to enable the BLA submission.
“We are encouraged to learn that FDA has heard the voices of the food allergy community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research and Education). “This hopeful advancement in the treatment of peanut allergic toddlers has the potential to make a positive impact on the millions of families that are urgently awaiting innovative treatment options, and the confirmatory study will certainly add to the rich data that has been compiled in this important disease space. We stand by DBV in their efforts to advance Viaskin and look forward to representing the patient perspective.”
Regulatory History of the Viaskin Peanut Patch in Toddlers 1 – 3
DBV and the FDA have been engaged in ongoing dialogue regarding the COMFORT Toddlers supplemental safety study in 1 – 3 year-olds with a peanut allergy. The focus of continued exchanges has been on patch adhesion, specifically:
The hierarchy of an adhesion assessment within the COMFORT Toddlers study (FDA requesting that it be a study objective vs. exploratory assessment);
The sufficiency of adhesion data collected during the EPITOPE study to fully characterize daily patch adhesion duration (wear time) given the EPITOPE adhesion data collection methodology, and, conversely, the collection methodology required to generate sufficient adhesion data to inform the Viaskin label in future studies; and
The clinical relevance and regulatory use of adhesion data collected in a study that does not include an efficacy assessment.
DBV’s proposed labeling solution, submitted to the FDA on June 28, 2024, became critical in exploring with the FDA, practical solutions to linking adhesion, efficacy and safety to best inform the label. These fruitful discussions have led to what DBV believes to be an actionable regulatory pathway.
Viaskin Peanut Patch in Children 4 – 7
In September 2024, DBV announced that patient screening had been completed for the Phase 3 efficacy trial of the Viaskin Peanut patch in peanut allergic children ages 4 – 7 years-old (VITESSE). A total of 654 subjects were enrolled, and DBV anticipates topline data in the fourth quarter of 2025.
The COMFORT Children safety study is expected to be initiated in the second quarter of 2025. This study plans to enroll approximately 250 subjects to raise the total number of 4 – 7 year-olds on active treatment across the development program to approximately 600, consistent with prior FDA guidance. These two studies will constitute the core studies for a BLA submission in 4 – 7 year-olds.
EMA Regulatory Update
DBV sought scientific advice from the EMA regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 year-olds, and a positive VITESSE study in 4 – 7 year-olds, could constitute an MAA submission for a 1 – 7 year-old indication for peanut allergy patients using the modified patch, along with a new safety study in 1 – 3 year-olds with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.
The most recent European Academy of Allergy & Clinical Immunology (EAACI) draft Guidelines on the Management of IgE-mediated Food Allergy has the following recommendation: “In children and adolescents with IgE-mediated peanut allergy, peanut epicutaneous immunotherapy is suggested to achieve desensitization, if available.” This recommendation further supports the potential clinical benefit of the Viaskin Peanut Patch, if approved, in Europe and the unmet medical need.
Financial Update
Based upon preliminary estimates and information available to the Company as of the date of this announcement, DBV’s cash and cash equivalents amount to $46.4 million as of September 30, 2024, compared to $66.2 million as of June 30, 2024, a net decrease by $19.8 million comprising :
$22.5 million of net cash flow used in operating activities, mainly external clinical-related expenses notably progress on patient enrollment in VITESSE Phase 3 clinical trial, Regulatory and Medical activities as well as Manufacturing Operations.
Partially offset by Research Tax Credit complementary refund for years 2020 to 2022 of $3.0 million.
These preliminary financial results reflect the Company’s estimates and are based on currently available information. The Company’s actual financial results for the quarter ended September 30, 2024 have not yet been finalized by management or reviewed by the Company’s independent auditors. This preliminary financial information is not a comprehensive statement of all financial results for the quarter ended September 30, 2024. Accordingly, undue reliance should not be placed on these preliminary financial results.
The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of this announcement, the Company’s available cash and cash equivalents is not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. Based on current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations into 1Q 2025 and intends to seek additional capital as it continues research and development efforts and prepares for the launch of Viaskin Peanut, if approved.
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, October 22nd, at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
United States: +1-877-346-6112
International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
subslover
2年前
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
December 23 2022 - 01:30AM
GlobeNewswire Inc.
Alert
Print
Share On Facebook
Montrouge, France, December 23, 2022
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
DBV expects to initiate patient screening in Q1 2023 with the last patient screened by 1H 2024 and topline results anticipated in 1H 2025
Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical trial that will evaluate the modified Viaskin™ Peanut 250 µg patch (DBV712) in peanut-allergic children ages 4 to 7 years. The updated protocol will be submitted to study sites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval.
In the Partial Clinical Hold (PCH) letter, the FDA requested changes to certain elements of the VITESSE protocol with the intent for the trial to support a Biologics License Application (BLA). The FDA communication contained four protocol modifications: the redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, the reclassification of certain adverse events (AEs) to adverse events of special interest (AESIs) and an increase in the number of trial participants on active treatment.
Key design elements of VITESSE such as inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the PCH letter and have not changed.
“We are pleased that the FDA has lifted the partial clinical hold on the VITESSE study and anticipate initiating patient screening in Q1 2023,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am proud of our team for continuing to advance important pre-study activities these last several weeks so that we are prepared to act quickly to re-launch VITESSE following today’s announcement.”
Following receipt of the PCH letter, DBV and the FDA discussed how VITESSE protocol modifications could best support the Agency’s review of a potential BLA for Viaskin Peanut as a peanut allergy treatment.
In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter. The FDA stated that DBV may proceed with VITESSE with the following changes included in the revised protocol:
The updated VITESSE Instructions for Use (IFU) will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch. The updated IFU now outlines that Viaskin Peanut 250 µg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day.
Patch adhesion will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies. In post-PCH discussions, DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform.
Four AEs will be classified as AESIs. These AEs – which include AEs leading to inhaled or systemic corticosteroid or epinephrine use, systemic allergic reactions, and Grade 4 local application site (skin) reactions – were collected and assessed in all previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed.
DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo. The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. The protocol design of the safety study will be submitted to the FDA and is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that DBV previously conducted with Viaskin Peanut in children ages 4 to 11 years.
The Company does not expect the additional safety study to have an impact on the Company’s cash runway guidance as DBV had included a provision for a possible supplemental safety trial in its cash runway assumptions. The Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data.
“Following a very productive dialogue with the FDA, we have incorporated the Agency’s modifications to VITESSE into the study protocol and look forward to initiating patient treatments,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “I am confident that the VITESSE study, when completed, will add to the growing body of evidence demonstrating the ability of our novel drug-device immunotherapy platform, Viaskin Peanut, to address significant unmet needs among peanut-allergic children and their families.”
DBV anticipates initiating VITESSE patient screening in the first quarter of 2023 with the last patient screened in 1H 2024 and topline results anticipated in 1H 2025.
About VITESSE
The VITESSE trial will enroll 600 subjects, randomized 2:1 active versus placebo. The study will involve approximately 80 trial sites across the United States, Canada, Australia and Europe. Dr. David Fleischer, Children’s Hospital Colorado, will act as the principal investigator.
The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at Month 12. The primary efficacy analysis includes the success criterion of a lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%.
A treatment responder is defined as either a subject with a baseline eliciting dose (ED) ≤30 mg who reaches an ED ≥300 mg of peanut protein at Month 12, or a subject with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at Month 12. A double-blind, placebo-controlled food challenge (DBPCFC) will be administered at baseline and Month 12 to determine a subject’s ED at both timepoints.
During the screening period, subjects will undergo an initial visit with assessment for eligibility according to peanut skin prick test (SPT) and serum peanut IgE. Those meeting these criteria will proceed to a DBPCFC to confirm their peanut allergy and establish an entry peanut ED. The entry DBPCFC will be 1 mg peanut protein, and will escalate up to a highest single dose of 100 mg peanut protein. Subjects who react with an ED at or below the dose of 100 mg peanut protein are considered eligible. At Month 12, a post-treatment DBPCFC will be performed, with a starting dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, 1,000 mg. Secondary efficacy endpoints include changes in Cumulative Reactive Dose, ED and severity of allergic reaction at Month 12 food challenge.
Hot Features
プレミアム
登録してリアルタイムのチャート、分析ツール、価格を入手してください。
TrendTrade2016
1週前
glenn1919
2週前
tw0122
2週前
Monksdream
1月前
TheFinalCD
2月前
stocksrising
2月前
Renee
8月前
BostonSportsNut
2年前
81vette
2年前
ErnieBilco
3年前
