Lipella Pharmaceuticals' (LIPO) shares jumped nearly 35% in recent Tuesday trading after the company reported positive topline results from its phase 2a multicenter dose-ranging trial of LP-310, a liposomal-tacrolimus oral rinse for oral lichen planus.
LP-310 demonstrated clinically meaningful reductions in pain, ulceration, and inflammation while maintaining a strong safety profile, with no product-related serious adverse events or patient dropouts, while showing statistically significant improvements in patient-reported and investigator-measured efficacy endpoints at weeks 1, 4, and 6.
The study's first cohort, consisting of eight participants receiving 0.25 mg twice daily, showed significant improvements in key clinical metrics.
Investigator Global Assessment scores improved from 3.50 to 1.75 by week 4, while Reticulation, Erythema, and Ulceration scores decreased from 27.75 to 12.69, and pain scores dropping from 6.63 to 2.38, the company said.
The trial has advanced to a higher dose cohort of 0.5 mg/10 mL at seven US sites, with recruitment to conclude by mid-2025. The company plans to submit a Phase 2b investigational new drug application and seek breakthrough therapy designation in H2.
Price: 4.11, Change: +1.06, Percent Change: +34.75
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