Sept. 18 Quick Takes: Anthos’ mAb meets Phase II bleeding endpoint
Plus: Priority review for Orchard’s ex vivo gene therapy and more from BioNTech, Broken String and FDA
Anthos Therapeutics Inc. said a Phase II study of dual Factor XI/XIa inhibitor abelacimab was stopped early after the antibody showed an “overwhelming reduction” in bleeding events compared with direct oral anticoagulant Xarelto rivaroxaban. The AZALEA-TIMI 71 trial evaluated abelacimab vs. Xarelto in 1,287 patients with atrial fibrillation on a composite endpoint of major and clinically relevant non-major bleeding. The Blackstone Life Sciences unit of Blackstone Inc. (NYSE:BX) and Novartis AG (SIX:NOVN; NYSE:NVS) partnered to launch Anthos in 2019, soon after Blackstone acquired Clarus.
Orchard Therapeutics Inc. (NASDAQ:ORTX) said FDA has granted priority review to its BLA for Libmeldy atidarsagene autotemcel (OTL-200) to treat metachromatic leukodystrophy, and set a PDUFA date of March 18, 2024. The BLA includes data from 39 pediatric patients who received the therapy at Ospedale San Raffaele in Milan; it is approved in the EU and other European territories. The autologous, ex vivo stem cell gene therapy uses a lentiviral vector to target the ARSA gene...