Idorsia has started a Phase III registration study to evaluate the efficacy of experimental drug candidate selatogrel for treating suspected acute myocardial infarction (AMI) or heart attack.
The double-blind, randomised, placebo-controlled study is designed to evaluate the clinical efficacy and safety of 16mg selatogrel when self-administered upon the occurrence of symptoms, suggesting an AMI along with standard-of-care.
The SOS-AMI study aims to enrol around 14,000 patients who are at high risk of recurrent AMI at around 250 sites in 30 countries.
Administered subcutaneously, Selatogrel is a reversible P2Y12 receptor antagonist designed to provide a rapid antiplatelet response in patients with AMI.
Idorsia has already conducted two Phase II studies, one with patients exhibiting chronic coronary syndromes and another with AMI patients.
In both studies, Selatogrel was safe and well tolerated, and triggered fast and reversible inhibition of platelet aggregation.
Idorsia managing director Global Clinical Development head Guy Braunstein said: “Selatogrel has a pharmacokinetic and pharmacodynamic profile that results in a fast onset, and short duration of action, making it suitable for administration at the onset of symptoms.
“It is potent and highly selective for the P2Y12 receptor and was well-tolerated in the Phase II studies. Further to these properties, selatogrel is suitable for subcutaneous administration, giving rise to the real innovation in SOS-AMI: self-administration as early as possible after onset of symptoms of a suspected AMI.
“We are now ready to put selatogrel in the hands of patients and I am looking forward to seeing SOS-AMI progress in the course of the next 2-3 years.”
According to the company, there are no treatment options available for the critical time from onset of AMI symptoms to first medical contact, apart from aspirin.
Idorsia is developing selatogrel to address this medical gap and improve survival rates among AMI patients.
In April, Idorsia reported positive data from the Phase III clinical trial of daridorexant for the treatment of insomnia.