November 30, 2023

Sol-Gel Technologies Screens First Patient for SGT-610 Phase 3 Study

• SGT-610 has “Orphan Drug” designation status in the U.S. and E.U. and “Breakthrough Therapy” designation status in the U.S., as potentially the first and only therapy aimed at preventing new BCCs in Gorlin syndrome
• Sol-Gel to host a virtual Key Opinion Leader event to discuss the Gorlin syndrome patient experience and treatment needs, as well as the SGT-610 Phase 3 trial on Wednesday, December 6th at 12 pm ET

NESS ZIONA, Israel, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (Nasdaq: SLGL) (“Sol-Gel”), a dermatology company leveraging innovative approaches to develop pioneering treatments for patients with severe skin conditions, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced that it has begun Phase 3 testing of SGT-610 (patidegib gel, 2%) for Gorlin syndrome with the first patient screened. SGT-610 is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors. Patidegib was acquired by Sol-Gel from PellePharm and is currently the only therapy in development to prevent the development of new BCC lesions in Gorlin syndrome patients.

"We are pleased to initiate patient screening in this Phase 3 trial that has been long awaited by the Gorlin syndrome patient community,” said Alon Seri-Levy, Ph.D., Chief Executive Officer of Sol-Gel. “To increase the probability of success of this trial we have refined screening criteria to enroll subjects with more severe disease at baseline in terms of a higher baseline number of facial BCC lesions. This may help to better demonstrate the preventive effect of the medication. Other insights that we are using in our Phase 3 trial design strategy are to pre-screen patients for a specific genetic mutation associated with Gorlin syndrome and to ease patient study compliance by reducing the number of study visits over the 12-months of treatment. We hope that our learnings to optimize this trial’s design will help Sol-Gel advance this important drug candidate to Gorlin syndrome patients with no approved therapies.”

“We anticipate SGT-610, with Orphan- and Breakthrough designation from FDA, could have a market potential of over $300 million. We look forward to discussing the experience of the Gorlin syndrome patient, the market opportunity for SGT-610, and the Phase 3 trial design during a Key Opinion Leader investor day that we are hosting on December 6th,” added Dr. Seri-Levy.

Sol-Gel will conduct the Phase 3 study to investigate SGT-610 in approximately 140 subjects at approximately 40 experienced clinical centers in North America, United Kingdom and Europe. For more information about the trial and study design, visit NCT06050122.

Read more.

About the Scholar

Hematology, Oncology

Jean Tang, MD, PhD

Stanford University
Harrington Scholar-Innovator

More about Jean Tang