Idorsia achieves endpoints in Phase 2 'selatogrel' studies

Idorsia announced on Tuesday that Phase 2 clinical studies with its P2Y12 receptor antagonist ‘selatogrel’ (ACT-246475) in patients with stable coronary artery disease, and patients with acute myocardial infarction, had met their pharmacodynamic objectives of “significantly inhibiting” platelet aggregation.

The Swiss biotechnology company said subcutaneous administration of selatogrel demonstrated a rapid onset of action - within 15 minutes - with the height of its effect extending over four to eight hours, depending on the dose.

It said the predefined extent of platelet aggregation inhibition was seen in at least 89% of the patients in both chronic and acute situations across doses.

Selatogrel was reportedly safe and well tolerated in both studies, and there were no treatment-emergent serious bleeds.

“The company is now preparing for the end of Phase 2 meetings with health authorities, where it will discuss the Phase 3 study,” Idorsia’s board said in its statement.

“Results of the studies will be shared at upcoming scientific congress and published in scientific literature.”