Torqur AG reports promising Phase 2 results for bimiralisib, full data expected by June

Torqur AG, a biotechnology company specializing in oncology and dermatology treatments, has presented interim Phase 2 clinical trial results for its investigational therapy, bimiralisib topical gel (2%), at the American Academy of Dermatology (AAD) Annual Meeting 2025 in Orlando, Florida. The study, designed to assess the safety and efficacy of bimiralisib in Actinic keratosis, has yielded promising results, with 60% of patients demonstrating full or partial lesion clearance.

Bimiralisib, a selective pan-PI3K/mTOR inhibitor, targets the metabolic pathways involved in Actinic keratosis progression. The interim data suggests the treatment has strong potential to serve as a non-invasive alternative to existing therapies. With full study results expected in June 2025, the findings could support regulatory discussions and commercial pathways for bimiralisib clinical development in dermatology.

Why Is Actinic Keratosis a Major Concern in Dermatology?

Actinic keratosis is the most common pre-cancerous skin condition, affecting approximately 58 million Americans annually. It results from prolonged sun exposure and is characterized by rough, scaly patches that may develop into cutaneous squamous cell carcinoma (cSCC) if left untreated. Given the high incidence and risk of malignancy, early intervention is crucial.

Traditional treatments for Actinic keratosis include cryotherapy, photodynamic therapy, and topical treatments, but these approaches often present challenges such as pain, incomplete lesion clearance, and high recurrence rates. As a result, there is an increasing demand for more effective and better-tolerated therapies. The development of bimiralisib in Actinic keratosis marks a shift toward targeted treatments that address the underlying mechanisms of the disease rather than merely removing visible lesions.

What Do the Interim Phase 2 Trial Results Reveal About Bimiralisib?

The Phase 2 trial evaluating bimiralisib in Actinic keratosis has provided encouraging interim results. The study included two treatment arms: a 2-week regimen and a 4-week regimen, both designed to assess the drug’s efficacy and safety. Among trial participants, 60% achieved either full or partial lesion clearance, with a notably higher response rate in the 4-week treatment group, where 70% of patients experienced significant improvement. The 2-week treatment group showed a 50% improvement rate, reinforcing the potential of bimiralisib as a targeted therapy for Actinic keratosis.

In terms of safety, bimiralisib topical gel was well tolerated, with adverse events classified as mild (Grade 1) and resolving quickly after treatment completion. The strong safety profile supports its potential as a low-risk therapeutic option for patients seeking non-invasive treatments. These interim findings indicate that bimiralisib could offer a new standard of care for Actinic keratosis, providing a balance of high efficacy and minimal side effects.

How Does Bimiralisib Work in Actinic Keratosis?

Bimiralisib operates by targeting the PI3K/mTOR pathway, a cellular signaling mechanism that plays a crucial role in cell growth, survival, and metabolism. In Actinic keratosis, dysregulation of this pathway leads to uncontrolled cell proliferation, contributing to lesion development and potential malignant transformation. By selectively inhibiting pan-PI3K and mTOR, bimiralisib disrupts these processes, effectively reducing lesion formation and preventing progression to more severe conditions.

Unlike conventional treatments that physically remove lesions, bimiralisib modifies the disease at a molecular level, which could lead to longer-lasting benefits and lower recurrence rates. The continued analysis of bimiralisib clinical development will determine whether its mechanism of action translates into superior long-term outcomes compared to current therapies.

What Are Experts Saying About Bimiralisib’s Potential?

Experts in dermatology and oncology have highlighted the clinical significance of bimiralisib in Actinic keratosis, particularly its potential to provide a well-tolerated, targeted alternative to traditional treatments. Many researchers believe that targeting the PI3K/mTOR pathway represents an innovative approach that not only addresses lesion clearance but also helps prevent progression to cutaneous squamous cell carcinoma.

With Actinic keratosis being a precursor to non-melanoma skin cancer, dermatology specialists have emphasized the importance of developing non-invasive therapies that mitigate patient discomfort and enhance treatment accessibility. The positive trends observed in the interim trial results suggest that bimiralisib in Actinic keratosis could be a breakthrough therapy, addressing both efficacy and tolerability concerns.

What Are the Next Steps for Bimiralisib in Actinic Keratosis?

Torqur AG is continuing its clinical investigation into bimiralisib, with patient enrollment underway at leading dermatology centers in Switzerland. The company anticipates releasing full trial data in June 2025, which will provide further insights into the long-term efficacy and safety of the treatment.

The next phase of research will focus on assessing bimiralisib’s performance in larger patient populations and determining how it compares with existing standard-of-care treatments. The findings could inform potential regulatory submissions, paving the way for future commercialization.

Conference attendees can access the interim analysis through the AAD online viewing portal and on-site stations, while public access will be available later in the year through the Journal of the American Academy of Dermatology. The dermatology community is closely watching the progress of bimiralisib in Actinic keratosis, as its success could redefine treatment options for patients worldwide.