Lipella reports positive Phase 2a results for LP-310 in oral lichen planus; FDA okays expanded access

LIPELLA PHARMACEUTICALS INC.

FDA approved Expanded Access Program for LP-310 (oral rinse for OLP) on Feb 6, 2025.
Phase 2a topline: statistically significant improvements in pain (NRS), IGA, REU, and OLPSSM at weeks 1, 4, 6.
No product-related SAEs, no dropouts; tacrolimus blood levels undetectable or minimal in all patients.
Trial advancing to 0.5 mg dose cohort; recruitment to conclude first half 2025.
Company plans Phase 2b IND submission and Breakthrough Therapy request in second half 2025.

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