Sol-Gel Technologies Advances SGT-610 for Gorlin Syndrome and SGT-210 for Darier Disease
Key Insights
Sol-Gel's Phase 3 clinical trial of SGT-610 for Gorlin Syndrome (search) is actively enrolling patients across 40 clinical sites, with topline results expected in H2 2026.
A proof-of-concept study for SGT-210 in Darier disease (search) is ongoing, with plans to file a Phase 2 IND in Q2 2025, targeting a market with significant unmet needs.
Sol-Gel shareholders approved Mori Arkin as interim CEO, effective January 1, 2025, succeeding founder Dr. Alon Seri-Levy, who will remain as a consultant.
Sol-Gel Technologies is making strides in its clinical programs, particularly with SGT-610 for Gorlin syndrome (search) and SGT-210 for Darier disease (search), while also reporting its third-quarter financial results for 2024. The company's key initiatives and financial health were highlighted in a recent corporate update.
SGT-610 for Gorlin Syndrome
The Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome (search) is actively underway. This pivotal study aims to enroll approximately 140 subjects across 40 experienced clinical centers in multiple countries, including the U.S., Spain, the Netherlands, Germany, Italy, France, and the UK. Currently, agreements have been established with 43 centers, with approximately 40 already activated. Topline results are anticipated in the second half of 2026.
SGT-610 is a topically applied patidegib, a hedgehog signaling pathway blocker. Gorlin syndrome (search), an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is characterized by mutations in the PTCH1 (search) gene, leading to uncontrolled division of basal cell carcinoma (search) (BCC) tumor cells. Patidegib is designed to block the SMO (search) signal, allowing cells to function normally and reducing the production of new tumors. If approved, SGT-610 is expected to be the first approved product for the prevention of new BCC lesions in Gorlin syndrome patients, targeting a market exceeding $300 million annually.
SGT-210 for Darier Disease
Sol-Gel is also progressing with its proof-of-concept study for SGT-210 (topical erlotinib) in patients with Darier disease (search). Darier disease is a rare, genetic keratinization disorder characterized by scaly crusted papules in a seborrheic distribution and in skin folds. The market potential for Darier disease treatments is estimated between $200 to $300 million, representing a significant unmet medical need.
SGT-210 is a topical erlotinib drug candidate formulated for the treatment of Darier disease (search) and other hyperkeratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor that acts on the epidermal growth factor receptor (search), a protein present on cell surfaces that plays a key role in promoting cell growth and division. Sol-Gel anticipates filing for a Phase 2 IND in Q2 2025, following the successful completion of the proof-of-concept study and required pre-clinical studies.
Leadership Transition
Sol-Gel's shareholders have approved the appointment of Mori Arkin as Interim CEO, effective January 1, 2025. Arkin will succeed Sol-Gel's founder and current CEO, Dr. Alon Seri-Levy, who will remain as a consultant to the Company for at least one year.
Financial Highlights
For the third quarter of 2024, Sol-Gel reported total revenue of $5.4 million, primarily consisting of licensing revenue from Padagis, Galderma, Searchlight, and seven new license agreements, compared to $0.2 million for the same period in 2023. Research and development expenses were $4.8 million, compared to $4.7 million for the same period in 2023. The company reported a net loss of $0.4 million for the third quarter of 2024, compared to a net loss of $5.7 million for the same period in 2023.
As of September 30, 2024, Sol-Gel had $14.6 million in cash, cash equivalents, and deposits, and $14.6 million in marketable securities, for a total balance of $29.2 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2026.
Mori Arkin, Executive Chairman of Sol-Gel, stated, "The quarterly results reflect our continuous effort to maximize the value of our assets, while exploring business opportunities for non-dilutive funding. We continue to conduct the pivotal Phase 3 clinical trial of SGT-610 as planned and are encouraged by the rate of recruitment of patients."