• Phase I trial met primary endpoint, with Xolatryp showing a strong safety profile
• No serious adverse events recorded, only mild or moderate adverse events
• Pharmacokinetic analysis confirmed predictable and linear blood concentrations

Nyrada Inc, a clinical-stage biotechnology company, has provided an update on the unblinded results of its Phase I clinical trial for Xolatryp, its lead candidate for treating acute myocardial infarction. The trial met its primary endpoint, with all Xolatryp doses being safe and well-tolerated, and no dose-limiting or dose-related safety issues. The six cohorts included 48 healthy participants, with 36 receiving the drug and 12 receiving placebo. The pharmacokinetic analysis found that Xolatryp showed predictable and linear blood concentrations over time, reaching therapeutic levels within 10 minutes of administration and exceeding the IC90 (the drug concentration required to inhibit the target TRPC3/6/7 channels with 90% effectiveness) throughout the six-hour infusion. No serious adverse events were recorded, and only mild or moderate adverse events occurred, with the most common being headache. Nyrada is continuing to finalize its submission to the Human Research Ethics Committee for a Phase IIa clinical trial targeting patients with acute myocardial infarction, which is scheduled to commence in the first quarter of 2026.

Nyrada remains on track to commence the Phase IIa clinical trial for Xolatryp in patients with acute myocardial infarction in the first quarter of 2026.