Friday, November 22, 2019 9:15:04 AM
This article, makes it sound like the bridging studies may have actually started back in September.
Phase 2 data of selatogrel, Idorsia’s highly-selective P2Y12 receptor antagonist, presented at ESC 2019
September 03, 2019
https://www.globenewswire.com/news-release/2019/09/03/1910237/0/en/Phase-2-data-of-selatogrel-Idorsia-s-highly-selective-P2Y12-receptor-antagonist-presented-at-ESC-2019.html
Guy Braunstein, MD and Head of Idorsia Global Clinical Development, added:
“The Phase 2 data demonstrate that subcutaneous administration of selatogrel 16mg in patients with stable CAD and patients with AMI has a rapid onset of action, within 15 minutes, with the effect extending over 4-8 hours. Based on the speed at which selatogrel takes effect, the duration of that effect, and the safety and tolerability profile, self-administration of selatogrel at the very onset of symptoms of a suspected AMI has potential as a highly innovative approach to AMI management.”
In consultation with health authorities, Idorsia is preparing a large, international, multi-center, Phase 3 study to investigate the efficacy and safety of subcutaneous self-administration of selatogrel for the treatment of a suspected AMI in patients with an history of AMI. Participating patients will be trained on when to inject and instructed on how to self-administer treatment. An integrated drug delivery device is being developed through usability and reliability studies to ensure functional efficacy can be demonstrated ahead of the Phase 3 study.
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