Tyra Biosciences Receives FDA Nod for TYRA-300 Phase 2 Trial

Tyra Biosciences, Inc., a biotechnology company in the clinical development stage, revealed that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TYRA-300, enabling the company to move forward with a phase 2 clinical study of TYRA-300 for children with achondroplasia (BEACH301).

TYRA-300 is a promising experimental oral inhibitor that targets FGFR3 specifically, aiming to sidestep the side effects linked to inhibiting FGFR1, FGFR2, and FGFR4. TYRA-300 is currently under assessment for metastatic urothelial cancer in the SURF301 trial, with interim clinical proof-of-concept results presented at the ENA 2024 conference.

"IND clearance to proceed with BEACH301 is a significant milestone for the achondroplasia community and for TYRA, as we move into the clinic to treat our first rare skeletal dysplasia indication," said Todd Harris, CEO of TYRA.  "We believe FGFR3 is the right target for achondroplasia, with almost one hundred percent of cases being driven by a specific mutation in the FGFR3 gene.  TYRA-300 has the potential to precisely engage FGFR3 to potentially achieve a higher annualized growth velocity, and lead to important functional outcomes and clinical benefits such as improvements in reach, gait and spinal disease."

Harris continued, "The currently available therapy is a once-daily injection that delivers modest increases in annualized growth velocity.  As a highly selective FGFR3 inhibitor, we are hopeful that TYRA-300 may provide an improved therapeutic option for achondroplasia, and we are excited about our opportunity to potentially deliver improvements with our differentiated oral therapy in BEACH301."