Idorsia Ltd. said selatogrel quickly prevented blood from clumping together in certain heart disease patients during a mid-stage trial, meeting the main goal of the study.
The phase 2 studies measured how well selatogrel prevented platelets in the blood from clumping together, according to Idorsia's Dec. 18 press release. Platelet aggregation, while crucial in closing wounds, can also lead to blood clots that block arteries.
In both studies, selatogrel significantly inhibited platelet aggregation and worked within 15 minutes of being injected under the skin. The height of the drug's effect extended over four to eight hours, depending on the dose, Idorsia said. At least 89% of patients achieved the trials' predefined extent of platelet aggregation inhibition. Idorsia said selatogrel was safe and well-tolerated in both studies, with no serious bleeds arising from treatment.
The first trial enrolled 346 adults with stable coronary artery disease, randomized to receive selatogrel in 8- or 16-milligram doses, or placebo. Coronary artery disease is the most common type of heart disease and the leading cause of death in the U.S.
The second trial enrolled 48 adults with acute myocardial infarction, randomized to receive 8- or 16-milligram doses. Acute myocardial infarction is the medical name for a heart attack. Patients in the second study received selatogrel if they experienced symptoms of a heart attack lasting between 30 minutes and six hours.
Patients from both studies were also taking conventional therapies that prevent blood clots.
Switzerland-based Idorsia develops and markets drugs for unmet clinical needs. The company said it will discuss proceeding selatogrel to late-stage development with health authorities and will share full trial results at an upcoming scientific congress.