Torqur AG: Interim Phase 2 clinical trial results for Actinic keratosis treatment

Torqur AG, an innovative clinical-stage biotechnology company dedicated to advancing treatments for oncology and dermatology, is delighted to announce the presentation of interim results from its ongoing Phase 2 clinical trial in Actinic keratosis at the American Academy of Dermatology (AAD) Annual Meeting, taking place in Orlando, Florida, from March 7–11, 2025.

Actinic keratosis, the most common pre-cancerous dermatological condition, affects 58 million Americans each year. Primarily driven by an overactive PI3K pathway, early research suggests targeted therapy could hold promise for many patients. The study evaluates the safety and efficacy of topical gel bimiralisib, a selective pan-PI3K/mTOR inhibitor, in patients with Actinic keratosis. The interim results highlight strong potential, paving the way for further clinical advancement.

Key interim findings include:

• Efficacy: Bimiralisib topical gel (2%) demonstrated strong efficacy with 60% of patients who completed the initial treatment and follow up visit showing either complete or partial clearance of their lesions. Notably, 70% 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, reinforcing its potential as an effective targeted therapy for Actinic keratosis.
• Safety: The safety profile indicates that bimiralisib topical gel (2%) was well tolerated, with treatment-related adverse events primarily being mild (Grade 1) and resolving quickly after treatment completion.

“These interim results mark a significant step forward in our commitment to bringing innovative therapeutic options to patients with Actinic keratosis”, said Dr. Vladimir Cmiljanovic, CEO at Torqur AG. “We are highly encouraged by the positive trends observed and remain focused on advancing the study toward the next phase of development.”

Prof. Dr. David Fisher, Chair of the Dermatology Department at Massachusetts General Hospital (MGH) and Harvard Medical School, offered: “Most instances of cutaneous squamous cell carcinomas begin as Actinic keratosis. 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.”

“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,” said 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, added: “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.”

The Phase 2 trial is enrolling patients across two renowned dermatology centers in Switzerland, Prof. Alexander Navarini in Basel and Prof. Olivier Gaide in Lausanne, with full results expected in June 2025. The complete interim analysis will be accessible to conference attendees through the AAD online viewing portal and on-site viewing stations starting at the beginning of the meeting. However, public access via the Journal of the American Academy of Dermatology supplement will occur later in the year.

For more information on the trial, please visit  www.clinicaltrials.gov, ID NCT06319794.