Lipella Pharmaceuticals (LIPO, Financial) has announced encouraging results from the second cohort of its Phase 2a multicenter trial exploring LP-310, an oral rinse formulation, aimed at treating oral lichen planus. Having achieved full enrollment across all three planned dose groups, the study noted significant improvements at the 0.50 mg dose level in a range of efficacy metrics, emphasizing LP-310's potential as a non-steroidal treatment option.
The trial, conducted across seven sites in the United States, has progressed to the final and highest dose cohort, with conclusive results anticipated by the second quarter of 2025. Key metrics demonstrated substantial progress, with the Investigator Global Assessment score dropping from 3.42 at baseline to 2.71 in the first week, further improving to 1.71 by the fourth week.
Additionally, the Reticulation, Erythema, and Ulceration Score saw a decline from 26.91 at baseline to 17.02 within the initial week. Pain levels, measured on a numerical scale, showcased a positive trend, reducing from 6.42 to 4.25 in the first week, and further down to 2.25 by the fourth week.
Importantly, LP-310 continues to demonstrate a strong safety profile, with no serious adverse events reported and full adherence to the rinse regimen by all participants. Pharmacokinetic analyses confirmed that systemic exposure to tacrolimus remained undetectable, underscoring the localized effectiveness of the treatment.
With the trial's enrollment now complete, Lipella Pharmaceuticals plans to release final topline data from the 1.0 mg cohort in early 2025, setting the stage for future regulatory discussions and subsequent phases in clinical development.
