Lipella Reports Additional Positive Data from Phase 2a Trial of LP-310 in Oral Lichen Planus

Final Cohort Results Expected in Q2 2025 as Program Advances Toward Phase 2b and Regulatory Engagement

Lipella Pharmaceuticals (Nasdaq: LIPO) has announced new topline results from the second dose cohort (0.50 mg) of its ongoing Phase 2a trial evaluating LP-310, a liposomal tacrolimus oral rinse for oral lichen planus (OLP). The data build on prior findings from the first cohort and continue to show statistically significant improvements across key clinical measures.

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 at the 0.50 mg dose resulted in meaningful reductions in inflammation, ulceration, symptom severity, and pain, with improvements observed in both investigator- and patient-reported outcomes. No treatment-related serious adverse events were reported, and all participants completed the study regimen. Pharmacokinetic analysis showed tacrolimus levels remained minimal or undetectable, supporting LP-310's targeted delivery profile.

The trial is now fully enrolled across all three planned dose levels. Topline results from the final 1.0 mg cohort are expected in the second quarter of 2025. These data are intended to support the submission of an Investigational New Drug (IND) application for a Phase 2b trial, continued regulatory engagement, and a planned request for FDA Breakthrough Therapy designation.

LP-310 is being developed as a non-steroidal, locally delivered treatment for oral lichen planus, a chronic inflammatory condition with no FDA-approved therapies.

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COMTEX_464806355/2927/2025-04-22T12:01:33