Lipella Reports Statistically Significant Results from Second Cohort in LP-310 Phase 2a Trial for Oral Lichen Planus
Pittsburgh, Pennsylvania, USA, April 23rd, 2025, Chainwire
Findings reinforce localized efficacy profile; topline data from final dose group expected Q2 2025
Presentation of trial data to be delivered at 2025 AAOM/EAOM International Meeting in May
Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on reformulating existing therapeutics for underserved conditions, today announced positive topline results from the second cohort (0.50 mg) of its ongoing Phase 2a dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse, in patients with symptomatic oral lichen planus (OLP).
The 0.50 mg cohort was treated over a four-week period, with Week 4 serving as the primary endpoint. Week 6 data reflect follow-up assessments two weeks after the end of treatment.
Treatment with LP-310 at the 0.50 mg dose demonstrated statistically significant improvements across key clinical endpoints, including reductions in inflammation and ulceration, decreased symptom severity and pain, and improved global response scores. Investigators also observed visible improvement in oral lesions, including resolution of ulcerations in some patients during the treatment period. By Week 6, two weeks after treatment cessation, a return toward baseline was observed. This pattern is consistent with a localized therapeutic effect and supports LP-310’s mechanism of action.
The formulation was well tolerated, with no treatment-related serious adverse events and no study discontinuations. Pharmacokinetic analysis confirmed minimal systemic absorption of tacrolimus, supporting its targeted, local delivery.
As an extension of the clinical update, Lipella also announced today that an abstract featuring the LP-310 Phase 2a trial has been accepted for podium presentation at the 2025 AAOM/EAOM International Meeting on Oral Medicine. The presentation will highlight topline results and will be delivered by Dr. Alessandro Villa of the Miami Cancer Institute on May 15.
The study is now fully enrolled across all three planned dose cohorts. Final results from the 1.0 mg cohort are expected in Q2 2025 and are intended to support multiple development milestones, including:
- Finalizing Phase 2a clinical dataset
- Advancing regulatory discussions
- Preparing for Phase 2b IND submission in late 2025
- Pursuing FDA Breakthrough Therapy designation
“These results mark meaningful progress for LP-310 and further strengthen our confidence in its clinical and commercial potential,” said Jonathan Kaufman, Co-Founder and CEO of Lipella Pharmaceuticals.
“The data demonstrate statistically significant efficacy across multiple clinical measures while maintaining a strong safety profile,” added Dr. Michael Chancellor, Co-Founder and Chief Medical Officer.
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. Users can learn more at lipella.com and follow Lipella on X and LinkedIn .
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