US Market News
4月前
Tharimmune, Inc. Announces Corporate Rebrand to Canton Strategic Holdings, Inc., Marking Milestone in Canton Network Digital Asset Treasury StrategyFebruary 17, 2026 7:10 AM
PR Newswire (US)
New NASDAQ Ticker Symbol "CNTN" to Begin Trading February 18, 2026Company Positioned to Support Institutional Adoption of First Privacy-Enabled Public Blockchain Processing $9 Trillion in Monthly Transaction VolumeNEW YORK, Feb. 17, 2026 /PRNewswire/ -- Tharimmune, Inc. (NASDAQ: THAR) (the "Company") the first publicly traded company to leverage Canton Coin to support the Canton Network's ability to digitize traditional financial markets, today announced the launch of a corporate rebrand in alignment with its digital asset treasury strategy. Effective Wednesday, February 18, 2026, the Company will change its name to Canton Strategic Holdings, Inc. In connection with the name change, the common stock of the Company will begin trading on NASDAQ under the ticker symbol "CNTN" prior to market open on February 18, 2026.Established in November 2025 through a $545 million private placement, the Company executes a differentiated digital asset treasury strategy that seeks to drive value through initiatives including Canton Coin acquisition, operation of a Super Validator, and continued investment in applications that accelerate institutional utility and adoption of the Canton Network across capital markets. Canton Strategic Holdings remains the first and only publicly traded company supported by the Canton Foundation."Since launching our digital asset treasury strategy, we have continued to execute against a clear mandate to support institutional adoption of the Canton Network," said Mark Wendland, Chairman and CEO of the Company. "Our approval to operate a Super Validator on the Network, the expansion of institutional leadership on our Board of Directors, and our commitment to develop quarterly ecosystem reporting demonstrates our ability to strengthen the Canton ecosystem while delivering sustained value for shareholders."Significant recent milestones for the Company include:Securing approval as a Super Validator, aligned with a commitment to provide ecosystem reports on a quarterly basis.Deepening institutional expertise on the Board of Directors, including recent appointments of Former CFTC Commissioner Jill Sommers and DRW Chief of Staff William Wiley.Closing of a $55 million underwritten registered offering to provide the Company with additional growth capital for the continued expansion and development of its Canton-centric digital asset treasury strategy."From DTCC securing SEC consent for a pilot to tokenize U.S. Treasury securities, to global enterprises implementing onchain payroll, the utility of the Canton Network and its configurable privacy has quickly become the foundation for onchain financial rails," continued Mr. Wendland. "We are well-positioned to accelerate this modernization through our support of the Canton Network and strategic work to strengthen the ecosystem while driving value for shareholders."No action is required from stockholders in connection with the change of the Company's corporate name or ticker symbol. About the Company The Company (NASDAQ: THAR), is the first publicly traded company to leverage Canton Coin and support the Canton Network to advance institutional blockchain adoption and the digitization of financial markets. In addition to driving value through activities on the Canton Network, the Company also operates clinical-stage biotech research and development. For more information, visit: www.cantonstrategic.com Cautionary Note Regarding Forward-Looking StatementsThis press release contains statements that constitute "forward-looking statements" within the meaning of U.S. federal securities laws. Forward-looking statements are statements other than historical facts and include, without limitation, those regarding management expectations, strategy execution, market conditions, and the Company's involvement with the Canton Network. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially. Further information regarding factors that may affect the Company's prospects is included in its annual and quarterly reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov. The Company undertakes no obligation to update these statements except as required by law.Canton is a registered trademark of Digital Asset (Switzerland) GmbH. Digital Asset is not affiliated with, and has not sponsored or endorsed, the operations of Canton Strategic Holdings, Inc.ContactsMedia:
Gasthalter & Co.
(212) 257-4170
canton@gasthalter.comInvestors:
ir@cantonstrategic.comX: @CantonStrategic
LinkedIn: Linkedin.com/CantonStrategicHoldings
Website: www.cantonstrategic.com
View original content:https://www.prnewswire.com/news-releases/tharimmune-inc-announces-corporate-rebrand-to-canton-strategic-holdings-inc-marking-milestone-in-canton-network-digital-asset-treasury-strategy-302689437.htmlSOURCE Tharimmune, Inc.
Original: Tharimmune, Inc. Announces Corporate Rebrand to Canton Strategic Holdings, Inc., Marking Milestone in Canton Network Digital Asset Treasury Strategy
US Market News
4月前
Tharimmune, Inc. Appoints Mark Wendland Chairman of the Board and Names Angela Radkowski Chief Operating OfficerFebruary 6, 2026 8:15 AM
PR Newswire (US)
Leadership Expansion Supports Execution of Canton Network Infrastructure StrategyFormer DRW and Citadel Leader Joins as COO to Drive Institutional Platform ExpansionNEW YORK, Feb. 6, 2026 /PRNewswire/ -- Tharimmune, Inc. (NASDAQ: THAR) ("Tharimmune" or the "Company"), the first publicly traded company to leverage Canton Coin ("CC") to support the Canton Network's ability to digitize traditional financial markets, today announced that its Board of Directors (the "Board") has elected Mark Wendland, Chief Executive Officer, as Chairman of the Board and approved the appointment of Angela Radkowski as Chief Operating Officer, effective February 5, 2026. Mr. Wendland succeeds Vincent LoPriore, who will transition to a member of the Board after serving as Chairman since May 9, 2025.In her role as COO, Ms. Radkowski will oversee operational control functions and enterprise processes, including the implementation of Tharimmune's Canton Network quarterly research initiative and Super Validator activation."I am honored to assume the role of Chairman as we continue executing on our Canton Network-aligned digital asset strategy to help modernize financial market infrastructure," said Mark Wendland. "The Board, under the dedicated leadership of Vincent LoPriore, has demonstrated an unwavering commitment to building a governance and operating structure capable of supporting our digital asset treasury strategy, and Angela's appointment adds critical leadership at a pivotal moment. Her experience scaling complex financial systems will be instrumental as we advance institutional adoption of Canton Network and drive value for shareholders."Prior to her appointment, Ms. Radkowski served as Operations Strategy Lead and Chief of Staff to the Chief Operating Officer at DRW Holdings LLC, advising senior leadership, coordinating cross-functional communication, and managing high-priority, enterprise-level initiatives. Ms. Radkowski previously held positions within Citadel LLC's Treasury and Engineering organizations, where she was responsible for coordinating enterprise deliverables involving optimization, data engineering, and technology upgrades.Ms. Radkowski added, "The Canton Network introduces a new model for institutional finance — one that addresses the limitations of legacy infrastructure while enabling secure, scalable blockchain adoption. I am excited to join Tharimmune and help build the operational foundation required to support this transformation."Tharimmune established its differentiated digital asset treasury strategy in November 2025. In addition to driving value through CC acquisition and operating as a Super Validator, Tharimmune intends to invest in applications built on the Canton Network that accelerate institutional utility and adoption across capital markets. Tharimmune is the first and only publicly traded company supported by the Canton Foundation.About Tharimmune
Tharimmune, Inc. (NASDAQ: THAR) is the first publicly traded company to leverage Canton Coin and support the Canton Network to advance institutional blockchain adoption and the digitization of financial markets. In addition to driving value through activities on the Canton Network, Tharimmune also operates clinical-stage biotech research and development. For more information, visit: www.tharimmune.com.Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute "forward-looking statements" within the meaning of U.S. federal securities laws. Forward-looking statements are statements other than historical facts and include, without limitation, those regarding management expectations, strategy execution, market conditions, and the Company's involvement with the Canton Network. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially. Further information regarding factors that may affect the Company's prospects is included in its annual and quarterly reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov. The Company undertakes no obligation to update these statements except as required by law.ContactsMedia:
Gasthalter & Co.
(212) 257-4170
canton@gasthalter.comInvestors:
ir@tharimmune.comX: @TharimmuneInc
LinkedIn: https://www.linkedin.com/company/tharimmune-inc/
Website: https://tharimmune.com/
View original content:https://www.prnewswire.com/news-releases/tharimmune-inc-appoints-mark-wendland-chairman-of-the-board-and-names-angela-radkowski-chief-operating-officer-302681307.htmlSOURCE Tharimmune, Inc.
Original: Tharimmune, Inc. Appoints Mark Wendland Chairman of the Board and Names Angela Radkowski Chief Operating Officer
US Market News
4月前
Tharimmune Elects Jill Sommers and William Wiley to Board of DirectorsFebruary 2, 2026 8:15 AM
PR Newswire (US)
New Directors Strengthen Governance as Company Advances Canton Network InfrastructureFormer CFTC Commissioner Jill Sommers Brings Decades of Regulatory and Public Policy ExperienceDRW Chief of Staff William Wiley, CFA, Adds Extensive Leadership Experience Across Capital Markets and Global Operations NEW YORK, Feb. 2, 2026 /PRNewswire/ -- Tharimmune, Inc. (NASDAQ: THAR) ("Tharimmune" or the "Company"), the first publicly traded company to leverage Canton Coin ("CC") to support the Canton Network's ability to digitize traditional financial markets, today announced that its Board of Directors (the "Board") has elected Jill Sommers and William Wiley, CFA, to the Board, effective February 1, 2026."As we continue advancing the Canton Network's role in transforming financial market infrastructure through our digital asset treasury strategy, we are pleased to welcome Ms. Sommers and Mr. Wiley to the Board," said Mark Wendland, CEO of Tharimmune. "Both bring the experience, acumen, and entrepreneurial mindset required for effective governance. Their deep understanding of market structure and regulatory frameworks will play a critical role in our support of the Canton Network."Ms. Sommers brings nearly three decades of experience in derivatives and financial markets, including serving two consecutive terms as a Commissioner of the U.S. Commodity Futures Trading Commission ("CFTC"). She most recently served as the Chair of the Derivative Practice Group of Potamak Global Partners until March 2025. Earlier in her career, Ms. Sommers held several senior policy and regulatory roles, including Policy Director and Head of Government Affairs at the International Swaps and Derivatives Association ("ISDA") and Managing Director of Regulatory Affairs at the Chicago Mercantile Exchange."I am thrilled to bring my experience in derivatives regulation, corporate governance, and public policy to support the modernization of financial infrastructure," said Ms. Sommers. "I look forward to collaborating with other members of the Board as Tharimmune advances its vision for a compliant, blockchain-enabled financial system."Mr. Wiley brings deep capital markets experience as well as a track record leading complex global operations, including in his current role as Head of the Equities and Latency Sensitive Business Unit at DRW and Chief of Staff to DRW's Founder and Chief Executive Officer. Mr. Wiley previously served as Chief Operating Officer of DRW's Equities and Latency Sensitive Business Unit, overseeing day-to-day operations and scaling a global, multi-asset electronic trading platform. Prior to DRW, Mr. Wiley served as Global Head of Strategy at Instinet Holdings Inc. where he led firmwide strategy, operations, and strategic transactions across the institutional equities brokerage franchise."I am honored to join Tharimmune's Board and contribute to the firm's efforts to move our financial system off of aging, legacy technology and into a modern era," said Mr. Wiley. "Throughout my career I have sought optimizations to the workflows and systems underpinning global financial transactions. I strongly believe in the transformative nature of the Canton Network and I am excited to help guide Tharimmune's unique vision for participating in the ecosystem to drive shareholder value."Tharimmune established its differentiated digital asset treasury strategy in November 2025. In addition to driving value through CC acquisition and operating as a Super Validator, Tharimmune intends to invest in applications built on the Canton Network that accelerate institutional utility and adoption across capital markets. Tharimmune is the first and only publicly traded company supported by the Canton Foundation.About Tharimmune
Tharimmune, Inc. (NASDAQ: THAR) is the first publicly traded company to leverage Canton Coin and support the Canton Network to advance institutional blockchain adoption and the digitization of financial markets. In addition to driving value through activities on the Canton Network, Tharimmune also operates clinical-stage biotech research and development. For more information, visit: www.tharimmune.com.Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute "forward-looking statements" within the meaning of U.S. federal securities laws. Forward-looking statements are statements other than historical facts and include, without limitation, those regarding management expectations, strategy execution, market conditions, and the Company's involvement with the Canton Network. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially. Further information regarding factors that may affect the Company's prospects is included in its annual and quarterly reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov. The Company undertakes no obligation to update these statements except as required by law.ContactsMedia:
Gasthalter & Co.
(212) 257-4170
canton@gasthalter.comInvestors:
ir@tharimmune.comX: @TharimmuneInc
LinkedIn: https://www.linkedin.com/company/tharimmune-inc/
Website: https://tharimmune.com/
View original content:https://www.prnewswire.com/news-releases/tharimmune-elects-jill-sommers-and-william-wiley-to-board-of-directors-302676288.htmlSOURCE Tharimmune, Inc.
Original: Tharimmune Elects Jill Sommers and William Wiley to Board of Directors
US Market News
4月前
Tharimmune Announces Expanded Role as Super Validator on Canton NetworkJanuary 26, 2026 1:15 PM
PR Newswire (US)
Advances Digital Asset Treasury Strategy Through Contributions to Canton Network NEW YORK, Jan. 26, 2026 /PRNewswire/ -- Tharimmune, Inc. (NASDAQ: THAR) ("Tharimmune" or the "Company"), the first publicly traded company to leverage Canton Coin ("CC") to support the Canton Network's ability to digitize traditional financial markets, today announced it has been approved to operate a Super Validator on the Canton Network, advancing its ability to secure transactions on the network while accruing rewards in the form of CC to bolster its digital asset treasury.
Tharimmune will provide in-depth quarterly research highlighting onchain analytics, community development news, governance and "tokenomics" updates, as well as roadmap updates for the network. Additionally, Tharimmune will host publicly available webinars each quarter, driving dialogue among ecosystem participants."Super Validators play a critical role on the Canton Network, responsible for over 700,000 daily transactions totaling $9 trillion in monthly transaction volume," said Mark Wendland, CEO of Tharimmune, Inc. "We are pleased to contribute to the network as it transforms global financial infrastructure and unlocks greater liquidity for financial markets through atomic settlement.""Tharimmune has demonstrated a unique ability to mobilize and drive alignment with institutional capital as we shape the future of our onchain financial system. We are happy to welcome Tharimmune as a Super Validator on the Canton Network," said Melvis Langyintuo, Executive Director at the Canton Foundation.The Canton Network is increasingly being chosen by global financial institutions for its ability to deliver programmable privacy at a time when firms continue to move transactions onchain in record numbers. Configurable privacy on the Canton Network allows market participants to capitalize on instantaneous settlement while maintaining discretion of critical information shared only with authorized counterparties and regulators.Tharimmune established its differentiated digital asset treasury strategy in November 2025. In addition to driving value through CC acquisition and operating as a Super Validator, Tharimmune intends to invest in applications built on the Canton Network that accelerate institutional utility and adoption across capital markets. Tharimmune is the first and only publicly traded company supported by the Canton Foundation.About Tharimmune
Tharimmune, Inc. (NASDAQ: THAR) is the first publicly traded company to leverage Canton Coin and support the Canton Network to advance institutional blockchain adoption and the digitization of financial markets. In addition to driving value through activities on the Canton Network, Tharimmune also operates clinical-stage biotech research and development. For more information, visit: www.tharimmune.com.Cautionary Note Regarding Forward-Looking StatementsThis press release contains statements that constitute "forward-looking statements" within the meaning of U.S. federal securities laws. Forward-looking statements are statements other than historical facts and include, without limitation, those regarding management expectations, strategy execution, market conditions, and the Company's involvement with the Canton Network. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially. Further information regarding factors that may affect the Company's prospects is included in its annual and quarterly reports filed with the U.S. Securities and Exchange Commission, available at www.sec.gov. The Company undertakes no obligation to update these statements except as required by law.ContactsMedia:
Gasthalter & Co.
(212) 257-4170
canton@gasthalter.com Investors:
ir@tharimmune.comX: @TharimmuneInc
LinkedIn: https://www.linkedin.com/company/tharimmune-inc/
Website: https://tharimmune.com/
View original content:https://www.prnewswire.com/news-releases/tharimmune-announces-expanded-role-as-super-validator-on-canton-network-302670020.htmlSOURCE Tharimmune, Inc.
Original: Tharimmune Announces Expanded Role as Super Validator on Canton Network
subslover
10月前
Tharimmune Reports Pharmacokinetic Simulation Results for TH104 as Prophylaxis Against Respiratory Depression from Fentanyl and Ultrapotent Opioids, Highlighting Potential Superiority Over Existing Treatments
RED BANK, NJ / ACCESS Newswire / August 20, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company dedicated to developing innovative therapeutic candidates for inflammation, immunology, and unmet medical needs announced positive results from a recent pharmacokinetic (PK) simulation analysis of its lead clinical asset, TH104, a buccal film formulation of nalmefene. The results reinforce the potential of TH104 as a prophylactic countermeasure for military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues.
Fentanyl and related compounds pose national security threats due to their high potency and the potential for a devastating mass casualty incident if weaponized. There is a critical need for countermeasures that can be administered proactively, prior to potential exposure, to prevent or mitigate the rapid onset of respiratory and nervous system depression from these potent agents.
The analysis used pharmacokinetic simulations of TH104 as prophylaxis for respiratory depression in exposure to synthetic opioids based on data from the literature. The concentrations of TH104 necessary to block fentanyl respiratory depression were derived and simulations involved data from our Phase 1 study to generate concentration time curves above these concentrations. Using a conservative nalmefene concentration target - a threshold effect, (i.e. the protection from respiratory depression) was found to be achieved in approximately 30 minutes post dose and shown to maintain above this protection for about 24 hours. This is a potential key superiority of TH104 compared to currently available options (e.g. naloxone injection products). While naloxone injection can be used as a life-saving rescue medication, its effect is relatively short-lived, often lasting approximately 30-90 minutes. The prolonged prophylactic window of TH104 could be crucial in high-risk environments where exposure is a constant threat and immediate access to medical personnel may be limited. The ability of TH104 to potentially provide sustained protection is a significant advancement in prophylactic care against these potent agents.
The buccal film delivery of TH104 is designed as a non-injectable, rapid absorption and convenient-to-use administration, which may be advantageous for first responders who may be wearing full protective gear. The recent positive feedback earlier this year from the U.S. Food and Drug Administration (FDA) confirming that no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application (NDA) submission provides a path forward. Tharimmune is dedicated to advancing TH-104 to provide a potentially effective and patient-friendly treatment as an option for those in need, beginning with its critical role in national security.
81vette
1年前
THAR,770k float,fda news out,I bought 1.43 as lotto,super risky,big spread,fast mover/gapper,hit 2.00 pre-mkt and tanked to 1.2 before open,could run again after-mkt but risky! Shares to short 100k and not dropping,also makes this risky and needs vol surges to continue
subslover
2年前
Tharimmune Announces $2.02 Million Private Placement to Advance Development Programs
BRIDGEWATER, NEW JERSEY / ACCESSWIRE / December 6, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company committed to pioneering therapies in immunology and inflammation, today announced it has entered into a securities purchase agreement to raise gross proceeds of approximately $2.02 million through a private placement.
The agreement includes the issuance of 961,446 shares of common stock (or common stock equivalents) and warrants to purchase up to an additional 480,723 shares of common stock. Each share (or common stock equivalent) is priced at $2.10 and is accompanied by a warrant. The warrants will have an exercise price of $2.031 per share, becoming exercisable six months after issuance and expiring five and one-half years from the date of issuance. The closing of this transaction is expected on or about December 9, 2024, subject to customary closing conditions.
Strategic Investors and Placement Details
The financing was led by Gravitas Capital and SDS Capital Group, alongside other biotechnology-focused private investors. President Street Global served as the exclusive placement agent for the offering, ensuring seamless execution of the transaction.
After deducting placement agent fees and other offering-related expenses, the Company intends to allocate the net proceeds toward clinical development, including advancing its flagship TH104 development program, as well as general working capital.
Advancing Innovation in Biotechnology
This financing reinforces Tharimmune's commitment to advancing its portfolio of therapeutic candidates. TH104, the Company's lead clinical asset, is designed to address chronic pruritus associated with primary biliary cholangitis (PBC), a rare and challenging autoimmune liver disease.
Regulatory Details
The securities in this private placement were offered under Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D thereunder. The shares of common stock and underlying warrants are not registered under the Securities Act or state securities laws. The Company has agreed to file a resale registration statement covering these securities to enable their future trading upon registration or qualification under applicable laws.
About Tharimmune
Tharimmune, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies in immunology, inflammation, and oncology. The Company's lead product candidate, TH104, leverages a unique transdermal buccal film technology designed to address inflammatory conditions, including pruritus associated with PBC. Tharimmune is also advancing TH023, an oral TNF-alpha inhibitor, and exploring novel multi-specific biologics targeting solid tumors. Through a licensing agreement with OmniAb, Inc., the Company harnesses cutting-edge antibody discovery platforms to target specified disease markers. Learn more at www.tharimmune.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying wo
subslover
2年前
Tharimmune Presents Positive Clinical Data at AASLD the Liver Meeting(R) to Support TH104 for Chronic Pruritus in Chronic Liver Disease
Significant correlation shown between blood levels and symptom relief; TH104 was well tolerated with no unexpected treatment-emergent adverse events
Phase 2 preliminary data for chronic pruritus in primary biliary cholangitis expected in 2025
BRIDGEWATER, NJ / ACCESSWIRE / November 18, 2024 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, presented new TH104 clinical data at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024, underway in San Diego from November 15-19. The Phase 1 trial was a single-dose, single-center, open-label, randomized study of TH104 transmucosal buccal film conducted in two cohorts of patients with chronic liver disease (CLD), with the primary outcome of safety and tolerability.
"This presentation at The Liver Meeting expands the audience for encouraging Phase 1 data with our lead candidate TH104," said Randy Milby, CEO of Tharimmune. "We look forward to initiating a Phase 2 multiple-ascending dose trial in the coming months to evaluate TH104 in chronic pruritus in primary biliary cholangitis (PBC) patients, with topline data expected in 2025. In the meantime, we continue to engage with both U.S. and EU regulatory authorities."
Data presented at The Liver Meeting include adverse events (AEs) as well as an assessment of patients' relief of pruritus symptom scores when correlated to pharmacokinetics (PK) of TH104. Patients with cholestatic liver disease and a known history of persistent generalized pruritus for at least 4 weeks prior to screening were included. After an overnight fast of 10 hours, subjects received a single low dose of TH104. Serial blood samples for PK analysis were taken, and patients were monitored for itch severity scores utilizing the Worst-Itch Numerical Rating Scale (WI-NRS), a relevant clinical outcome assessment for pruritus in chronic liver disease, and for itch intensity over a 24-hour period.
Pruritus is common in most liver diseases and the WI-NRS is a validated numerical rating scale displaying 11 numbers ranging from 0, representing "no itch," to 10, representing "worst imaginable itch," and patients are asked to pick the number corresponding to the intensity of their pruritus. Results from multiple large studies support the usefulness and validity of WI-NRS for evaluating change over time in clinical trials. Pearson's correlation coefficient (r) was used to assess the correlation between TH104 concentration (ng/ml) Area Under the Curve (AUC) and the change in WI-NRS score 48 hours after dosing.
This study screened 19 patients and 12 were enrolled with two types of CLD categorized as Child-Pugh A (cohort A) and Child-Pugh B (cohort B). The Child-Pugh score is a system for assessing the prognosis and necessity of transplant in CLD that provides a forecast of the increasing severity of a patient's liver disease and expected survival rate. The score is determined by scoring clinical measures of liver disease and the possibility of eventual liver failure, with Class A indicating mild liver disease and Class B indicating moderate liver disease with one-to-five-year survival rates of 95% and 75%, respectively. There were no patients enrolled in this study with the most severe Child-Pugh C classification.
The correlation coefficient between TH104 AUC and change in itch, r, was 0.7060, with a p-value of 0.0103 and a 95% confidence interval for r of 0.2220 to 0.9108.
Change in Itch Score vs. Pharmacokinetics of TH104
The mean baseline WI-NRS scores in Groups A and B were 4.33 and 6.17, respectively, translating to moderate-to-severe chronic pruritus at the start of the study. The mean baseline itch score for all 12 subjects was 5.25. At one-hour post-dosing with TH104, Group A and Group B had a mean decline in WI-NRS scores of 26.8% and 19.0%, respectively, and continued to decline two hours post-dose by 42.3% and 21.7%, respectively. Both cohorts continued to improve in mean itch scores at the four-hour and eight-hour time points, including the combined total subjects. At 24-hours post dosing, Group A and Group B achieved a mean decline of 30.7% and 35.2%, respectively, in pruritus scores. The mean reduction in itch scores for all 12 subjects 24 hours after a single dose of TH104 was 33.3%.
https://www.accesswire.com/imagelibrary/7ba7268b-85f5-4652-b5fd-20411233e6f8/943818/d035cfd1f0a71840d6ed70e964fa.jpgWI-NRS score over time
A total of two AEs (headache) were reported in two subjects over the course of the study. These AEs were mild and possibly related to study drug, with no serious adverse events reported. There were no deaths or other significant adverse events reported during the entire study. There were no new adverse events during the study, with events correlated with previous studies and a safety profile consistent with the literature for the active ingredient in TH104.
About TH104
TH104 is embedded with nalmefene onto a proprietary transdermal buccal film that easily adheres to the inside of the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory conditions. The molecule has a dual mechanism of action affecting both the µ-opioid receptor and the kappa-opioid receptor, as well as potentially inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited by the body's natural ligands have been known to be involved in the
subslover
2年前
Tharimmune Receives Positive Regulatory Feedback From EMA for TH104 Clinical Program for Chronic Pruritus in Primary Biliary Cholangitis
BRIDGEWATER, NJ / ACCESSWIRE / October 30, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, received positive feedback from a Scientific Advice meeting with the European Medicines Agency (EMA) that included guidance on a planned Phase 2 trial to advance TH104, the Company's lead clinical-stage candidate for moderate-to-severe pruritus in primary biliary cholangitis (PBC).
The EMA interactions specifically focused on both the Phase 2 and Phase 3 clinical program of TH104. Overall, the Agency noted that using Article 10(3), hybrid application, is acceptable and could enable referring to non-clinical and some safety data from the approved products. Regarding non-clinical information provided, the Agency endorsed the strategy presented by the Company and noted that there is no need to conduct additional animal studies and considered human exposure to be adequate to move forward. The Agency found the design and main features of the proposed Phase 2 study overall acceptable with some comments. The Agency also provided general guidance for the design of a future Phase 3 study.
"We are pleased with our interactions with both the FDA and EMA," said Randy Milby, CEO of Tharimmune. "The recent regulatory feedback from the EMA builds on the previous positive interactions with the FDA while providing a roadmap for TH104 for chronic pruritus in PBC, which continues to be a debilitating symptom for patients suffering from this rare condition. The progress with regulatory agencies is a testament to our continued commitment to advance innovative solutions in inflammation and immunology."
The Company plans to initiate a Phase 2 multiple-ascending dose trial in the coming months to assess the safety and tolerability of TH104, which will also assess the change from baseline in itch scores to evaluate chronic pruritus in PBC patients. The Company expects topline data in 2025 and continues to engage with both U.S. and EU regulatory authorities.
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