Topical Bimiralisib Achieves 92% Clearance Rate in Phase 2 Actinic Keratosis Trial
核心洞察
Torqur AG (搜索)'s topical bimiralisib gel 2% demonstrated a 92% complete or near-complete response rate in patients with Olsen grade 1 actinic keratosis (搜索) lesions in a phase 2 proof-of-concept study.
The randomized multicenter trial enrolled 46 patients across two Swiss dermatology centers, with 52% of patients in the 2-week cohort and 71% in the 4-week cohort achieving complete or partial lesion clearance.
The selective pan-PI3K (搜索)/mTOR (搜索) inhibitor showed favorable safety profile with only mild, localized skin reactions and four grade 2 events that resolved without intervention.
Torqur AG (搜索) announced compelling phase 2 results for topical bimiralisib gel 2% in treating actinic keratosis (搜索), with the selective pan-PI3K (搜索)/mTOR (搜索) inhibitor achieving a 92% complete or near-complete response rate in patients with Olsen grade 1 lesions. The findings were presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress in Paris.
Strong Efficacy Across Patient Populations
The randomized, multicenter phase 2 proof-of-concept study enrolled 46 patients across two leading Swiss dermatology centers: University Hospital Basel (搜索) and Lausanne University Hospital. The trial evaluated topical bimiralisib gel as a field-directed therapy for actinic keratosis (搜索) lesions on the scalp, face, and dorsal hands.
Results demonstrated substantial efficacy across treatment durations. Among all participants, 52% of patients in the 2-week treatment cohort and 71% in the 4-week cohort achieved an Investigator's Global Assessment (IGA) score of 0–1, indicating complete or partial clearance of lesions. Notably, all patients experienced some degree of lesion reduction following initial therapy.
The treatment showed effectiveness across different lesion grades. While patients with Olsen grade 1 lesions achieved the highest response rates at 92%, subgroup analysis revealed that patients with more severe Olsen grade 2 lesions also demonstrated significant improvement, with a 48% complete or near-complete response rate.
Favorable Safety Profile
The study demonstrated bimiralisib gel's strong tolerability profile. The majority of treatment-related adverse events were mild, localized skin reactions. Investigators identified only four grade 2 events among study subjects, all of which resolved without requiring medical intervention.
During an optional 8-week extension phase, retreatment proved feasible without generating new or significant safety concerns. Additional lesion improvements, including further instances of complete clearance, were observed with continued therapy.
Addressing Significant Medical Need
Actinic keratosis (搜索) affects more than 10% of the European population and represents the most common precancerous skin condition. The condition is associated with dysregulation of the PI3K (搜索)/mTOR (搜索) signaling pathway, making bimiralisib's mechanism of action particularly relevant for this indication.
"These results show that bimiralisib gel 2% has both efficacy and safety across different grades of actinic keratosis (搜索)," said Alexander Navarini, MD, PhD, chairman of dermatology at University Hospital Basel (搜索) and lead principal investigator. "This represents a promising new non-invasive option for patients, addressing a significant unmet need in dermatology."
Olivier Gaide, MD, PhD, head of the Center of Excellence for Skin Cancer and Melanoma at Lausanne University Hospital and principal trial investigator, emphasized the clinical significance: "With actinic keratosis (搜索) being the most common precancerous skin condition, these data highlight the great potential of this targeted topical therapy to counter progression to squamous cell carcinoma (搜索)."
Development Path Forward
Bimiralisib gel offers a novel mechanism-based therapeutic strategy designed to target early-stage skin lesions through selective pan-PI3K (搜索)/mTOR (搜索) inhibition. The compound's strong clinical efficacy and tolerability profile support its potential for further development in treating this prevalent precancerous condition.
"Presenting these Phase 2 results at Europe's most prestigious dermatology congress is a tremendous milestone," said Vladimir Cmiljanovic, CEO of Torqur AG (搜索). "The high rates of clearance and consistently favorable tolerability profile underscore bimiralisib's potential to become a new standard for patients with actinic keratosis (搜索). We are now preparing for the pivotal Phase 3 clinical trials and discussing with potential partners to bring this therapy closer to patients worldwide."