In phase 2 results, bimiralisib gel 2% demonstrated high efficacy and tolerability in treating actinic keratosis , achieving a 92% response rate in Olsen grade 1 lesions. The gel targets the PI3K/mTOR pathway, offering a novel, mechanism-based approach for managing early-stage skin lesions.

The randomized, multi-center study evaluated topical bimiralisib gel as a field-directed treatment for AK on the face, scalp, and/or back of hands. Results demonstrated substantial efficacy and a favorable safety profile, supporting further clinical development:

Efficacy: 92% of complete or near complete response with Olsen grade 1 patients, and overall, 52% of patients in the 2-week period and 71% in the 4-week period achieved an Investigator’s Global Assessment (IGA) score of 0–1 (complete or part

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