• HREC approval to assess Xolatryp at higher doses and longer infusion
• Amended protocol enhances options for Phase II trial design
• Final Phase I results expected in Q3 2025

Nyrada Inc, a clinical-stage drug discovery and development company, has announced an amendment to its Phase I clinical trial protocol for its lead candidate Xolatryp. The company has received approval from the Human Research Ethics Committee (HREC) to evaluate the safety, tolerability, and pharmacokinetics of Xolatryp in healthy volunteers at higher doses and over a longer infusion duration. The HREC's approval was based on the strong tolerability observed across all doses administered to date. Demonstrating safety under the amended protocol will provide Nyrada with greater flexibility in designing a Phase II trial, including the ability to optimize dosing for the target patient population. As a result of the amendments, the Phase I trial will now comprise six cohorts. Notwithstanding, final Phase I trial results are still expected in the quarter ending September 2025. Xolatryp has demonstrated preclinical efficacy as an acute treatment following ischemic stroke, traumatic brain injury, and acute myocardial infarction. The company has previously announced positive results from various preclinical studies, including neuroprotective and cardioprotective effects.

The amended Phase I protocol will provide Nyrada with greater flexibility in designing a Phase II clinical trial for Xolatryp, including the ability to optimize dosing for the target patient population.