Tyra Biosciences granted IND clearance from FDA for Phase 2 study of Tyra-300

Tyra Biosciences (TYRA) announced that the FDA cleared its Investigational New Drug application for Tyra-300 allowing the company to proceed with a Phase 2 clinical trial of Tyra-300 for children with achondroplasia. TYRA-300 is a potential first-in-class, investigational, FGFR3-selective inhibitor designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4. Tyra-300 is also being evaluated for metastatic urothelial cancer in the ongoing SURF301 study. BEACH301 will be a Phase 2 study evaluating Tyra-300 in children ages 3 to 10 with achondroplasia with open growth plates. The primary objectives of this study will be to assess safety and tolerability in children with achondroplasia and evaluate change from baseline in annualized growth velocity to determine the dose for further development. Tyra is also planning exploratory assessments of clinical outcomes such as functional improvements, changes in the spine, and quality of life measures. In July 2023 and January 2024, the FDA granted Orphan Drug Designation and Rare Pediatric Designation to Tyra-300, respectively, for the treatment of achondroplasia.