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.
The collaboration, facilitated through BridgeBio affiliate QED Therapeutics, focuses on the treatment of achondroplasia, hypochondroplasia and other skeletal dysplasias.
BridgeBio is eligible to receive $100m in upfront payment from Kyowa Kirin.
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.
Infigratinib is an oral small molecule inhibitor targeting fibroblast growth factor receptor 3 (FGFR3), which plays a crucial role in skeletal dysplasias such as achondroplasia and hypochondroplasia.
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.
Kyowa Kirin Strategy Division head, vice-president, chief strategy officer and managing executive officer Yasuo Fujii stated: “It is important for us to strengthen our portfolio by introducing pipelines in the fields of bone and mineral disorders, including achondroplasia.
“Based on the results from the latest clinical trials, we believe BridgeBio’s infigratinib has high potential for treating achondroplasia.
“We will steadily advance the development in Japan and aim to deliver life-changing value to people with skeletal dysplasias including achondroplasia.”
Last month, BridgeBio secured strategic financing of $1.25bn from Blue Owl Capital and the Canada Pension Plan Investment Board for genetic therapies.
