Torqur AG’s topical bimiralisib, a selective pan-PI3K/mTOR inhibitor, may help clear actinic keratosis (AK) lesions, according to interim Phase 2 results presented at the American Academy of Dermatology’s 2025 annual meeting in Orlando, FL.
Specifically, 60% of trial patients experienced full or partial AK lesion clearance.
Overactivation of the phosphoinositide 3-kinase (PI3K)/mechanistic target of the rapamycin (mTOR) pathway may contribute to the development of AK.
The Phase 2 trial is enrolling patients across two dermatology centers in Switzerland, with full results expected in June 2025.
In the study, 70% of AK patients in the 4-week treatment group (Arm B, 17 patients) and 50% in the 2-week treatment group (Arm A, 18 patients) showed significant improvement in AK lesions.
Bimiralisib topical gel (2%) was well tolerated, with treatment-related adverse events primarily being mild (Grade 1) and resolving quickly after treatment completion.
“With more than 58 million Americans living with these lesions, new targeted, non-invasive treatments for early-stage growths could help to alleviate the burden of this disease for thousands of patients,” says Prof. Dr. David Fisher, Chair of the Dermatology Department at Massachusetts General Hospital (MGH) and Harvard Medical School in Boston, MA, in a news release.
“The interim results from this Phase 2 trial are highly encouraging, showing strong potential for bimiralisib topical gel (2%) as an effective and well-tolerated treatment for actinic keratosis,” adds Prof. Dr. Alexander Navarini, lead Principal Investigator and Chairman of the Department of Dermatology and Allergy at the University Hospital Basel in Switzerland. “These encouraging interim findings further validate the need for effective, targeted therapies addressing the PI3K pathway in Actinic keratosis. We look forward to building on this momentum and further assessing bimiralisib’s clinical potential as the study progresses.”
Prof. Dr. Olivier Gaide, Principal Investigator and Head of the Center of Excellence for Skin Cancer and Melanoma at the Lausanne University Hospital, Switzerland, says: “The interim results from this Phase 2 trial indicate promising efficacy and tolerability of bimiralisib topical gel (2%), reinforcing its potential as a valuable targeted therapy for Actinic keratosis.”
