Sol-Gel Technologies screens first patient for SGT-610 Phase 3 study

Sol-Gel Technologies announced that it has begun Phase 3 testing of SGT-610 for Gorlin syndrome with the first patient screened. 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.