Sapience Therapeutics, Inc.

FDA Grants Orphan Drug Designation to Sapience Therapeutics' ST316 for Familial Adenomatous Polyposis

5 months ago

• The FDA has granted Orphan Drug Designation to ST316, a β-catenin antagonist, for treating familial adenomatous polyposis (FAP). • ST316 is a first-in-class drug designed to selectively inhibit the Wnt/β-catenin signaling pathway, crucial in FAP and colorectal cancer. • The designation provides Sapience Therapeutics with incentives, including potential grants, tax credits, and marketing exclusivity. • ST316 is currently in Phase 2 trials for colorectal cancer, with ongoing studies exploring its safety and efficacy.

Sapience Therapeutics Doses First Patient in Phase 2 Trial of ST316 for Colorectal Cancer

8 months ago

• Sapience Therapeutics has dosed the first patient in its Phase 2 dose expansion study of ST316, a first-in-class β-catenin antagonist, for colorectal cancer. • The Phase 2 trial will evaluate ST316 in combination with standard of care treatments across multiple lines of therapy for CRC patients. • ST316 is designed to selectively inhibit the Wnt/β-catenin signaling pathway in tumor cells, offering a targeted approach to cancer treatment. • The trial follows promising Phase 1 results demonstrating ST316's potential as an effective therapy for Wnt pathway-driven cancers with a favorable safety profile.