Healios has announced feedback received from the PMDA after recent consultation meetings to obtain guidance and advice pertaining to its application for MultiStem approval for ARDS, an orphan regenerative medicine program, on the basis of its Phase 2 ONE-BRIDGE study. The ONE-BRIDGE clinical trial was designed as a 30-patient, open label study, and demonstrated promising impact from MultiStem treatment on ventilator free days (VFD) and mortality. While the PMDA did not disagree with the efficacy and safety conclusions of the ONE-BRIDGE study, the PMDA advised Healios that additional supporting data is necessary for application for approval of MultiStem treatment for the ARDS indication. As a result of the guidance from the PMDA, Healios does not currently plan to apply for approval in Q2 2022. Healios will continue discussions with PMDA and work toward early application, and while it is undetermined at this time, it is expected that the application for approval is unlikely to take place in the current fiscal year.
Athersys is currently conducting its Phase 2/3 MACOVIA study, evaluating MultiStem treatment for ARDS patients, which includes patients diagnosed with ARDS due to COVID-19. The Company recently announced FDA approval to use product manufactured with its next generation bioreactor-based platform in the MACOVIA study.
https://finance.yahoo.com/news/athersys-reports-partner-healios-k-100000788.html
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