- Positive Phase 2a results from Lipella Pharmaceuticals' (LIPO, Financial) LP-310 trial for oral lichen planus.
- Strong safety profile with no serious adverse events and full patient compliance.
- Final data from the highest dose cohort expected in Q2 2025.
Lipella Pharmaceuticals (LIPO) has announced promising topline results from the second cohort of its Phase 2a trial for LP-310, a liposomal-tacrolimus oral rinse aimed at treating oral lichen planus (OLP). The 0.50 mg cohort demonstrated statistically significant improvements across multiple endpoints, including an Investigator Global Assessment improvement from 3.42 to 1.71 at week 4 (p=0.007), a reduction in REU Score from 26.91 to 11.88 at week 4 (p=0.003), and a decrease in pain rating from 6.42 to 2.25 at week 4 (p=0.003).
The treatment exhibited a strong safety profile with no treatment-related serious adverse events (SAEs) and complete patient adherence. With full enrollment achieved across all three dose cohorts, the trial is progressing to its final 1.0 mg dose cohort, with data anticipated in the second quarter of 2025.
Lipella plans to submit an Investigational New Drug (IND) application for a Phase 2b trial in late 2025, aiming to pursue FDA Breakthrough Therapy designation to potentially expedite the development of this non-steroidal, novel therapy for OLP, a condition with no current FDA-approved treatments.
