BridgeBio Pharma has entered a strategic partnership with Kyowa Kirin, granting the latter an exclusive licence for the development and commercialisation of infigratinib in Japan.
BridgeBio is entitled to receive royalty payments on Japanese sales of infigratinib, potentially reaching the high 20 per cent range, along with further milestone-based payments.
By hindering FGFR3, infigratinib addresses these conditions at their source.
BridgeBio made a significant advancement in December 2023 by dosing the first child in PROPEL 3, a Phase III pivotal trial.
The one-year placebo-controlled trial is designed to evaluate the safety and efficacy of infigratinib in patients aged three to 18 with open growth plates and diagnosed with achondroplasia.
The Phase III trial is a follow-up to the successful Phase II PROPEL 2 trial which showed promising results.
Infigratinib demonstrated a significant increase in annualised height velocity of plus 3.38cm per year – the strongest clinical result reported so far.
Kyowa Kirin plans to initiate discussions with Japan’s Pharmaceuticals and Medical Devices Agency in 2024.
The goal is to begin a Japanese-registered trial of the drug by 2025.
“We will steadily advance the development in Japan and aim to deliver life-changing value to people with skeletal dysplasias including achondroplasia.”
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