• No dose-limiting safety signals observed in participants dosed for six hours with Xolatryp
• Xolatryp considered well tolerated with no serious adverse events reported
• Pharmacokinetic assessment confirms predictable dosing within the tested range

Nyrada Inc. (ASX:NYR), a clinical-stage drug discovery and development company, has announced that the Safety Review Committee (SRC) of its Phase I clinical trial has concluded its final meeting to review blinded safety data. The SRC has assessed safety and pharmacokinetic data from the sixth and final cohort of the Phase I trial, where participants received Xolatryp at the same concentration as cohort five, but with dosing increased from three to six hours, resulting in a double dose. Consistent with findings from the previous five cohorts, the SRC confirmed an absence of safety signals, dose-limiting toxicities, or unexpected side effects among the 48 participants dosed in this Phase I study. No serious adverse events were reported, and all observed adverse events were classified as either mild or moderate. The SRC is satisfied that Xolatryp remains safe and well tolerated. Pharmacokinetic assessment of blood samples taken from cohort six participants also confirmed that participants were exposed to twice as much Xolatryp as cohort five participants, with a linear pharmacokinetic profile, consistent clearance, and stable volume of distribution demonstrating predictable dosing within the tested range. With final participant assessments now complete, the trial's Contract Research Organisation and clinical site are undertaking data cleaning, expected to be finalised by the end of August 2025. Once the database is locked and unblinded, a Clinical Study Report will be prepared, with an Interim Clinical Study Report projected for completion by the end of the September 2025 quarter, at which time topline data reporting on primary and secondary endpoints will be made available.

Nyrada is planning a Phase IIa clinical trial to assess the safety and exploratory effectiveness of Xolatryp in patients with acute myocardial infarction, seeking to assess safety and explore efficacy in patients with ST-Elevation Myocardial Infarction undergoing Percutaneous Coronary Intervention. The Phase IIa trial is planned for early calendar 2026.