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This Phase 3 trial is being conducted by PellePharrm, Inc., a biotech company located in the United States. The trial is for Patidegib Gel a topical treatment for the treatment of basal cell carcinomas. Increasingly the patient voice has become recognised as a essential component of the development of new treatments, and at a recent patient event PellePharm sought feedback from Gorlin patients in the UK.
Topical patidegib gel has shown early promise in a phase 2 clinical study for the mitigation of the BCC tumors in Gorlin Syndrome by blocking the disease at its source within the hedgehog signaling pathway. Topical patidegib was developed to provide the efficacy previously demonstrated by oral patidegib in phase 1 trials without the adverse systemic side effects. Patidegib’s gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for ongoing, at-home management of Gorlin Syndrome. Patidegib has received both Orphan Drug Designation and Breakthrough Designation from the FDA.
Watch this space for further detail.