Lipella Pharmaceuticals Reports Encouraging Early Tolerability Results in Phase 2a Trial of LP-310 for Oral Lichen Planus
Rhea-AI Summary
Lipella Pharmaceuticals (Nasdaq: LIPO) has reported encouraging early tolerability results in its Phase 2a trial of LP-310 for Oral Lichen Planus (OLP). Three participants have completed the four-week treatment with the oral rinse, showing good tolerability and no unpleasant taste. The multi-center study is evaluating the safety, tolerability, and efficacy of LP-310 at various doses.
LP-310 is a proprietary liposomal-tacrolimus formulation targeting the underlying causes of OLP. It aims to provide a more effective alternative to current palliative treatments by delivering concentrated therapeutic effects directly in the oral cavity while minimizing systemic toxicity. Notably, LP-310 is the only topical treatment in development for OLP, a condition with no FDA-approved pharmacotherapies.
The trial is being conducted at five active sites across the U.S. and is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. These early results suggest LP-310's potential as a breakthrough treatment for OLP, a condition that significantly impacts patients' quality of life.
Positive
- Early tolerability results for LP-310 in Phase 2a trial are encouraging
- LP-310 showed good tolerability and no unpleasant taste in initial participants
- LP-310 is the only topical treatment in development for Oral Lichen Planus
- Five U.S. sites are active and recruiting for the clinical trial
- Top-line data anticipated by year-end 2024
Negative
- None.
News Market Reaction
On the day this news was published, LIPO gained 10.32%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
PITTSBURGH, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on addressing serious diseases with significant unmet needs, today announced an update on its ongoing multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP). The Company reported that three participants have completed the four-week treatment with LP-310, an oral rinse, with encouraging findings: The treatment was well tolerated and had no unpleasant taste.
Dr. Michael Chancellor, Chief Medical Officer of Lipella Pharmaceuticals, commented, "Oral Lichen Planus is a highly disruptive condition that significantly impacts patients' daily lives. Given the severity of symptoms, tolerability is critical. Symptomatic side effects from current treatments often lead to frequent dose interruptions or delays, which can further complicate disease management. The fact that LP-310 has been well tolerated so far, without unpleasant taste, is very encouraging. We look forward to gathering more data on the safety side as we continue this pivotal trial.”
LP-310 is a proprietary liposomal-tacrolimus formulation derived from Lipella’s lead candidate, LP-10, which was initially developed for hemorrhagic cystitis. LP-310 targets the underlying causes of OLP and aims to provide a more effective alternative to the currently available palliative treatments by delivering a concentrated therapeutic effect directly in the oral cavity while minimizing systemic toxicity. Currently, there are no FDA-approved pharmacotherapies for Oral Lichen Planus, and LP-310 is the only topical treatment in development for OLP.
About the Study
The Oral Lichen Planus Clinical Trial is a multicenter, dose-ranging study involving adult male and female subjects (18 years and older) with symptomatic OLP. This study will evaluate the safety, tolerability and efficacy of LP-10 at doses of 0.25 mg, 0.5 mg and 1.0 mg of tacrolimus. Five sites across the U.S. are now active and recruiting participants for the trial. For more information, please visit https://lipella.com/oral-lichen-planus-treatment/ or https://clinicaltrials.gov/study/NCT06233591.
The clinical trial is expected to conclude by mid-2025, with top-line data anticipated by year-end 2024. The early results indicate the potential of LP-310 as a breakthrough treatment for OLP, a condition that severely impacts patients' quality of life.
About Lipella Pharmaceuticals
Lipella is a clinical-stage biotechnology company focused on developing new drugs by reformulating the active agents in existing generic drugs and optimizing these reformulations for new applications. Additionally, Lipella maintains a therapeutic focus on diseases with significant, unaddressed morbidity and mortality where no approved drug therapy currently exists. Lipella completed its initial public offering in December 2022. For more information, please visit www.lipella.com or LinkedIn
Forward-Looking Statements
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CONTACT
Dr. Jonathan Kaufman, CEO
Lipella Pharmaceuticals
Info@Lipella.com
1-412-894-1853
Jeff Ramson
PCG Advisory
jramson@pcgadvisory.com
646-863-6893
FAQ
What are the early results of Lipella Pharmaceuticals' Phase 2a trial for LP-310 (LIPO)?
When is Lipella Pharmaceuticals (LIPO) expecting to release top-line data for the LP-310 trial?
How many sites are currently active for Lipella Pharmaceuticals' (LIPO) Oral Lichen Planus clinical trial?
What makes LP-310 unique in the treatment of Oral Lichen Planus (LIPO)?
