|
AstraZeneca PLC on Friday said positive results from a Phase 3 trial of acoramidis are consistent with global findings, bring the drug closer to regulatory submission in Japan. The Cambridge, England-based pharmaceutical company’s Japan Phase 3 trial was testing acoramidis in adults with transthyretin-mediated amyloid cardiomyopathy, or ATTR-CM, a rare and fatal disease which causes progressive tissue damage culminating in heart failure. AstraZeneca said the ‘positive’ results in Japan ‘showed consistency’ with those from BridgeBio Pharma Inc’s global ATTRibute-CM Phase 3 trial. Criteria included survival, cardiac-related hospitalisations and quality of life at 30 months, with researchers ultimately seeking ‘greater estimated survival probability at 30 months than that observed among placebo patients in ATTRibute-CM’. AstraZeneca’s Alexion, AstraZeneca Rare Disease - which AstraZeneca created after acquiring Alexion Pharmaceuticals Inc in 2021 - maintains an exclusive licence with BridgeBio affiliate Eidos Therapeutics Inc to develop and commercialise acoramidis in Japan. AstraZeneca added that the ‘highly potent’ small molecule stabiliser was well-tolerated by patients, ‘with no safety signals of potential clinical concern identified’. ‘With one of the industry‘s largest amyloidosis pipelines exploring multiple therapeutic modalities, we are working to redefine treatment and care as well as offer new hope for this underserved community,’ said Alexion Chief Executive Officer Mark Dunoyer. ‘These positive results support our ambition to bring acoramidis to people living with ATTR-CM in Japan as soon as possible.’ Shares in AstraZeneca were up 0.2% at 10,447.28 pence on Friday morning in London. Copyright 2024 Alliance News Ltd. All Rights Reserved.
|
