NESS ZIONA, Israel — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with rare and severe skin conditions, today announced that the last patient has completed the last scheduled study visit in the Company’s pivotal Phase 3 clinical trial (SGT-610-01) evaluating SGT-610 (patidegib gel, 2%) for the prevention of BCC (basal cell carcinoma) lesions in adult patients with Gorlin syndrome.
The achievement of last patient last visit (LPLV) marks the completion of the patient treatment and follow-up phase of the study. The Company is now proceeding with database lock, followed by statistical analysis of the study results. Sol-Gel expects to report top-line results in late November 2026. The Company, investigators and patients remain blinded to treatment assignment.
The randomized, double-blind, vehicle-controlled Phase 3 study enrolled 113 patients with Gorlin syndrome, of whom 102 completed the study. Patients were randomized to receive SGT-610 or vehicle for 12 months of treatment. The primary endpoint of the study is the number of new BCCs on the face at month 12 after twice daily treatment. Secondary endpoints include the number of new surgically eligible BCCs (SEBCCs).
Mr. Mori Arkin, Executive Chairman and CEO of Sol-Gel, stated: “Reaching last patient last visit represents an important milestone for the SGT-610 program and brings us closer to understanding its potential to address the significant unmet need in patients with Gorlin syndrome. We are grateful to the patients, investigators and clinical site teams whose participation and commitment made this study possible. We look forward to completing the analysis and reporting the results.”
About Sol-Gel Technologies
Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety profile relative to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®.
Sol-Gel Investor Relations:
Eyal Ben-Or
Chief Financial Officer
[email protected]