Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 22

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 22
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met need.

Our solution, TYRA-300 in ACH

By engaging FGFR3 selectively at higher, safe doses, TYRA-300 may have the potential to meaningfully improve height, health and functional outcomes beyond what can be achieved with current therapies in development for children with ACH, HCH, SHOX deficiency, other FGFR3-driven genetic syndromes and idiopathic short stature.

In the Imagine Institute’s FGFR3Y367C/+ preclinical model, TYRA-300 administered daily at a 1.2 mg/kg dose for 15 days, increased body length in mice by 17.9% compared to the vehicle (p<0.0001) and increased the length of the femur (+22.6%), tibia (+33.0%) and L4-L6 (+23.5%) in mice (p<0.0001). 1.2mg/kg in mice roughly equates to a 0.5mg/kg dose in children and a 40mg dose in adults. TYRA-300 also demonstrated increases in long bone length in the Imagine Institute’s HCH mouse model. 

Development plans for TYRA-300 in ACH

In October 2024, we announced that the FDA cleared the Company’s IND for TYRA-300 to proceed with a Phase 2 clinical trial of TYRA-300 for children with ACH (BEACH301). BEACH301 will be a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating TYRA-300 in children ages 3 to 10 with ACH with open growth plates. The study will enroll children who are treatment-naïve (Cohort 1) and those who have received prior growth-accelerating therapy (Cohort 2) at multiple sites across the globe. Each of these cohorts is expected to enroll up to 10 participants per dose level (0.125, 0.25, 0.375, 0.50 mg/kg) for up to 12 months. Prior to initiation of Cohorts 1 and 2, the study will enroll a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. The primary objectives of the study will be to assess safety and tolerability in children with ACH and evaluate change from baseline in annualized growth velocity to determine the dose(s) for further development. Secondary objectives will include evaluating change