subslover
4週前
Lipella Pharmaceuticals Reports Positive Topline Phase 2a Results for LP-310 in the Treatment of Oral Lichen Planus
February 11 2025 - 5:46AM
Alert
Print
Share On Facebook
Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us,” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet needs, today shared topline analysis of its Phase 2a multicenter dose-ranging trial examining LP-310, a liposomal-tacrolimus oral rinse formulation of LP-10 being developed to treat oral lichen planus (“OLP”).
LP-310 demonstrated a strong safety profile, with no product-related serious adverse events (SAEs) and no patient dropouts. The trial showed statistically significant improvements across multiple patient-reported and investigator-measured efficacy endpoints at weeks 1, 4, and 6. LP-310 is the only oral rinse topical treatment currently in development for OLP.
Lipella Pharmaceuticals’ management will provide an overview of the Company and present results from the study during the BIO CEO & Investor Conference at The New York Marriott Marquis in New York City on Tuesday, Feb. 11, 2025, at 2:30 p.m. EST in the Plymouth Room.
Affecting about 6 million Americans, OLP is a chronic inflammatory condition that targets mucous membranes in the mouth, which can cause pain and make eating, drinking and even speaking uncomfortable. Characterized by symptoms such as burning pain, white patches, swollen tissue and open sores, OLP has no FDA-approved therapies.
“OLP represents a significant unmet need, and these remarkable results are highly encouraging, underscoring the meaningful value LP-310 can bring to both patients and the broader healthcare system,” added Jonathan Kaufman, Co-Founder and CEO of Lipella Pharmaceuticals. “With a chronic condition like OLP, delivering a targeted, effective treatment that overcomes the challenges of current options is vital. We are thrilled to advance its development and unlock its full potential.”
In the study’s first cohort, eight participants received a twice-daily dose of 0.25 mg of LP-310. Follow-up visits occurred at one and four weeks as well as two weeks post-treatment. The trial showed significant improvements across multiple efficacy endpoints while suggesting the safety and tolerability of LP-10 in adult patients with symptomatic OLP at the 0.25 mg/10 mL dose. The trial, which is active across seven U.S. sites, has progressed to the next higher dose cohort of 0.5 mg/10 mL.
Topline Findings:
Investigator Global Assessment (IGA): Improved from 3.50 ± 0.19 at baseline to 2.75 ± 0.31 at week 1 (p=0.031), 1.75 ± 0.45 at week 4 (p=0.008), and 2.80 ± 0.37 at week 6 (p=0.125).
Reticulation, Erythema, and Ulceration (REU) Score: Reduced from 27.75 ± 2.71 at baseline to 17.56 ± 2.51 at week 1 (p=0.004), 12.69 ± 3.06 at week 4 (p=0.004), and 19.60 ± 4.31 at week 6 (p=0.031).
Oral Lichen Planus Symptom Severity Measure (OLPSSM): Decreased from 15.38 ± 2.20 at baseline to 10.13 ± 2.34 at week 1 (p=0.035), 5.00 ± 2.28 at week 4 (p=0.004), and 8.60 ± 4.06 at week 6 (p=0.031).
Pain Numerical Rating Scale (NRS): Improved from 6.63 ± 0.80 at baseline to 4.38 ± 0.96 at week 1 (p=0.004), 2.38 ± 1.15 at week 4 (p=0.004), and 3.60 ± 1.63 at week 6 (p=0.031).
Global Response Assessment (GRA): Significant improvement was observed at week 4 (p=0.031).
“The statistically significant reductions in pain, ulceration, and inflammation observed in this trial provide strong grounds for the scientific validation of LP-310’s efficacy,” said Dr. Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals. “These results, combined with the treatment’s favorable safety profile, highlight the potential of LP-310 to deliver a highly targeted and tolerable therapy for OLP. We are deeply grateful to the patients and investigators for their contributions to this critical study and inspired by the marked improvements we’ve seen in patients’ lives. We look forward to advancing the trial to the next dose cohort and expanding recruitment across seven active U.S. sites as we continue to build on these promising findings.”
Safety and Tolerability
LP-310 was well tolerated with no product-related serious adverse events reported. All patients adhered to the twice-daily 10 mL rinse regimen, with no dropouts during the study. Pharmacokinetic analysis showed that tacrolimus blood levels were undetectable or minimal in all patients, underscoring LP-310’s potential to deliver localized benefits without systemic toxicity.
Next Steps in Development
Lipella continues to recruit for the trial, with plans to activate additional sites and complete the trial by mid-2025. The company is preparing for key milestones, including the submission of a Phase 2b clinical trial investigational new drug application in the second half of 2025 and a Breakthrough Therapy designation request to the FDA during the same period.
About LP-310
LP-310 is an innovative oral rinse formulation of LP-10 (tacrolimus), developed to address OLP. Designed to provide localized therapeutic effects while minimizing systemic exposure, LP-310 offers a promising new approach to managing this painful and often debilitating condition.
A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg, and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants. The study has reported topline data from its first cohort, with the second cohort currently dosing and topline data expected in the first half of 2025.
For more information about the study or to participate, visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.
About Lipella Pharmaceuticals Inc.
Lipella Pharmaceuticals is a clinical-stage biotechnology company focused on developing new drugs by reformulating active agents in existing generic drugs and optimizing these reformulations for new applications. Lipella targets diseases with significant unmet needs, where no approved drug therapies currently exist. The company completed its initial public offering in 2022. Learn more at lipella.com and follow us on X and LinkedIn.
subslover
4週前
Lipella Pharmaceuticals Granted FDA Approval for Expanded Access Program for LP-310 in Oral Lichen Planus
PITTSBURGH, Feb. 06, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Expanded Access Program (EAP) for LP-310, an oral rinse formulation designed to treat oral lichen planus (OLP).
LP-310 is an innovative, localized therapy formulated to provide targeted relief for OLP patients while minimizing systemic exposure. Oral lichen planus is a chronic inflammatory condition affecting the mucous membranes inside the mouth, often causing burning pain, white patches, swollen tissue and open sores. The condition impacts approximately 6 million Americans and currently has no FDA-approved therapies.
Expanded Access Programs allow patients who have unmet medical needs with serious or life-threatening conditions to access treatments outside of a clinical trial that are not yet approved by the FDA.
“Receiving FDA approval for expanded use of LP-310 represents a key milestone in our mission to address the significant unmet need in oral lichen planus treatment,” said Michael Chancellor, Co-Founder and Chief Medical Officer of Lipella Pharmaceuticals. “We are pleased to make LP-310 available to patients beyond our Phase 2a clinical trial through this expanded access program. With no approved therapies currently available, this approval strengthens our commitment to advancing LP-310 as a potential solution for patients living with this painful and often debilitating condition.”
The FDA’s approval for expanded use reinforces LP-310’s potential as a new therapeutic option for OLP and supports ongoing clinical development efforts.
About LP-310
LP-310 is an oral rinse formulation of LP-10 (tacrolimus) developed to target inflammation and immune response in OLP patients. Designed for localized therapeutic effects, LP-310 minimizes systemic exposure, reducing the risks associated with long-term steroid use. A Phase 2a multicenter, dose-ranging clinical trial is currently underway to evaluate the safety, tolerability and efficacy of LP-310 in adult participants with symptomatic OLP. The trial includes three dose levels (0.25 mg, 0.5 mg and 1.0 mg of tacrolimus) and is being conducted across seven active U.S. sites, which are now recruiting participants.
tw0122
5月前
.53+ 33% Lipella Pharmaceuticals Announces U.S. Patent Allowance for Innovative Liposomal Drug Delivery Platform
Source: GlobeNewswire Inc.
Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on developing therapies for serious diseases with unmet medical needs, today announced the receipt of a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for its proprietary liposomal drug delivery platform. The patent application, U.S. Patent No. 17/829,960, titled "Delivery of Agents Using Metastable Liposomes," covers key innovations in Lipella’s platform technology for delivering therapeutic agents via liposome-based vehicles.
The patent allows claims that cover Lipella’s method for using metastable liposomes to deliver a variety of therapeutic agents, including the company’s lead assets, LP-10 and LP-310. This breakthrough technology enables precise, targeted delivery, improving the safety and efficacy of treatments across multiple therapeutic areas, including oncology, cancer survivorship, and immunotherapy.
Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, commented, "The allowance of this patent is a significant milestone for Lipella as it strengthens our intellectual property portfolio and supports our ongoing efforts to advance therapies for conditions such as hemorrhagic cystitis and oral lichen planus. Our liposomal drug delivery system offers a safer and more effective means of administering therapeutics like tacrolimus by targeting disease sites directly and minimizing the systemic side effects typically associated with these treatments."
This newly allowed patent provides broad intellectual property protection for Lipella’s drug delivery platform, which optimizes delivery to epithelial tissues such as those lining the mouth, bladder, colon, esophagus, vagina, and urethra. It extends market exclusivity and strengthens Lipella’s competitive position, particularly for its two lead clinical assets currently in Phase 2 trials. With additional patents covering the company's formulations in the U.S., Australia, and Canada until 2035, Lipella is poised for further growth and development as it continues to advance its clinical pipeline.
About Lipella’s Lead Clinical Assets: LP-10 and LP-310
LP-10 is a liposomal formulation of tacrolimus designed for intravesical administration to treat hemorrhagic cystitis (HC), a rare but severe condition characterized by bleeding from the bladder. LP-10 has shown promising safety and efficacy results in a multicenter Phase 2a trial, where it improved urinary symptoms in patients. The FDA has granted Orphan Drug Designation to LP-10 for the treatment of moderate to severe HC, further underscoring its potential to address this critical unmet need. A Phase 2b multicenter placebo-controlled trial is ready to begin.
LP-310 is an innovative oral rinse formulation of LP-10, designed to treat oral lichen planus (OLP), a chronic autoimmune disease affecting the mucous membranes of the mouth. LP-310 offers a promising new approach to treating OLP, which affects millions of Americans and currently lacks an approved pharmacotherapy. A Phase 2a multicenter trial is underway with anticipated top-line data by year-end and trial completion by mid-2025.
About Hemorrhagic Cystitis (HC)
Hemorrhagic cystitis is a serious condition often resulting from radiation therapy or chemotherapy, marked by severe bleeding in the bladder. With no FDA-approved drug treatments available, LP-10 is positioned to become a breakthrough therapy for patients suffering from this debilitating condition.
About Oral Lichen Planus (OLP)
Oral lichen planus is a chronic autoimmune disease that causes inflammation and lesions in the oral mucosa. It can lead to significant discomfort, scarring, and increased risk of oral cancer. Despite affecting six to seven million people in the U.S., there are no approved treatments, and current therapies offer only symptomatic relief.
crudeoil24
1年前
Shares of Lipella Pharmaceuticals Inc. (LIPO) rocketed 52.2% higher in very active tracing Friday, after the Pittsburgh-based biotechnology company's investigational new drug application for its oral lichen planus treatment was approved by the U.S. Food and Drug Administration. Trading volume in the stock, which was the best performer on the major U.S. exchanges, blasted higher to 30.7 million shares, compared with the full-day average of about 6,400 shares. The stock has soared 150% in the three days since it last closed below the $1 mark, and has run up 164% amid a six-day winning streak. as Lipella described, OLP is a chronic, inflammatory autoimmune oral muscosal disease. It is a "highly morbid" condition with malignant potential that affects between 1% and 4% of the world population. Lipella's stock has now gained 18.6% over the past three months, but was still 57% below its initial public offering price of $5.75; the company went public on Dec. 20.
-Tomi Kilgore
For more from MarketWatch: http://www.marketwatch.com/newsviewer
Hot Features
プレミアム
登録して、同じ考えを持つ投資家と議論するためのアクティブなフォーラムで相互作用するためのアクティブなフォーラムに参加してください。
TrendTrade2016
4週前
TheFinalCD
5月前
glenn1919
5月前
Monksdream
7月前
Swammmie1040
7月前
MartinLutherKing
7月前
oldstocks
1年前
MiamiGent
2年前
81vette
2年前
