BridgeBio announces positive feedback from FDA on PROPEL3

BridgeBio Pharma announced positive feedback from the U.S. FDA and the EU EMA on key elements of the trial design for PROPEL3, its pivotal Phase 3 study of infigratinib in children with achondroplasia. Both regulatory bodies indicated that a single, one-year, 2:1 randomized, placebo-controlled trial would be acceptable as a registrational study for approval, which clears the path for initiation of the trial by the end of 2023. PROPEL3, the Phase 3 registrational study is a randomized, double-blinded, multi-site, placebo-controlled clinical trial, which will evaluate the safety and efficacy of infigratinib in children with achondroplasia aged 3 to 18 years with open growth plates. The primary endpoint will be change from baseline in AHV, with secondary endpoints including proportionality, height Z-score, and impact on medical complications. BridgeBio is also committed to exploring the potential of infigratinib on the wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasias, which hold significant unmet needs for families. Based on the positive results to date, the Company has been enrolling children in the run-in for PROPEL3 and expects to initiate PROPEL3 by the end of the year.