Self-Injected Antiplatelet for Acute MI Enters Phase 3 Testing

Megan Brooks

June 30, 2021

A phase 3 study testing the safety and efficacy of the fast-acting, self-administered P2Y12 receptor antagonist selatogrel (Idorsia Pharmaceuticals) for the treatment of suspected acute myocardial infarction (AMI) is underway, the company has announced.

Two published phase 2 studies — one in patients with chronic coronary syndromes and one in patients with AMI — showed fast and reversible inhibition of platelet aggregation after a single self-injected dose, with the effects lasting over roughly 8 hours.   

"The idea for patients to self-inject early in the onset of symptoms is truly innovative," Deepak L. Bhatt, MD, MPH, chair of the steering committee for the phase 3 Selatogrel Outcome Study in Suspected Acute Myocardial Infarction (SOS-AMI), said in a news release.

"The subcutaneous route of administration could overcome the onset delay observed with oral compounds from the same class," said Bhatt, who is also executive director of interventional cardiovascular programs at Brigham and Women's Hospital Heart & Vascular Center, Boston, Massachusetts.

Patient-Centric Study

The US Food and Drug Administration has designated the investigation of selatogrel for the treatment of a suspected AMI in adults with a history of AMI as a "fast-track" development program, Idorsia notes in their news release.

The Swiss company has partnered with Antares Pharma, a US-based leader in autoinjector and rescue pen technologies, to design and customize an autoinjector for selatogrel.

The phase 3 SOS-AMI trial is an international, multicenter, double-blind, randomized, placebo-controlled, parallel-group study that will assess the clinical efficacy and safety of 16 mg selatogrel when self-injected (on top of standard of care) when symptoms suggestive of AMI occur.

The primary efficacy endpoint is the occurrence of death from any cause or nonfatal AMI after any self-administered study treatment.

The study will enroll roughly 14,000 patients at high risk of recurrent AMI from around 250 sites in about 30 countries.

SOS-AMI is a patient-centric study designed with input from patients, the company said. Participants will be trained on how to recognize AMI symptoms, how and where to self-inject treatment, and to call for emergency medical help immediately.

"SOS-AMI pushes the boundaries of heart attack care provision. It puts the patient at the center of the study and empowers them to manage their heart attack symptoms," commented Mary Mooney, PhD, Trinity College Dublin, Ireland, who is a member of the steering committee for SOS-AMI.

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