Xolatryp Phase I Trial Advances with Highest Dose and Extended Infusion

Nyrada Advances Clinical Trial Milestone

Biotech company Nyrada Inc. has announced the commencement of the sixth and final cohort in its Phase I clinical trial for Xolatryp™, a novel small-molecule therapy targeting TRPC ion channels. This progression follows a thorough review by the Safety Review Committee (SRC), which found no safety concerns in the preceding cohort despite administering the highest dose to date.

The Phase I trial, designed to assess safety, tolerability, and pharmacokinetics in healthy volunteers, has so far demonstrated a clean safety profile. Cohort 5 participants received a 3-hour intravenous infusion at a dose equivalent to that which showed promising 42% cardioprotection in preclinical studies. Importantly, no dose-limiting toxicities or adverse effects were reported, clearing the way for the final cohort.

Doubling Exposure to Unlock Critical Data

Cohort 6 will maintain the same concentration of Xolatryp as Cohort 5 but will extend the infusion duration to 6 hours, effectively doubling the total dose exposure. This extended dosing is expected to provide vital pharmacokinetic and safety data, offering Nyrada greater flexibility in designing its upcoming Phase II trial. The trial is conducted under an amended protocol approved by the Human Research Ethics Committee and is registered with the US National Institutes of Health.

Final readouts from the Phase I trial are anticipated in the September quarter of 2025, which will be a pivotal moment for Nyrada as it evaluates the potential of Xolatryp to progress into later-stage clinical development.

Xolatryp’s Promise in Cardioprotection and Neuroprotection

Xolatryp is positioned as a first-in-class therapy with dual cardioprotective and neuroprotective properties. Preclinical studies have demonstrated significant benefits, including an 86% cardioprotective effect in myocardial ischemic-reperfusion injury models and a 42% neuroprotective effect in stroke models. Additionally, recent studies showed Xolatryp reduced arrhythmias linked to sudden cardiac death and provided neuroprotection following traumatic brain injury.

These promising results underpin the clinical development strategy and highlight the potential impact Xolatryp could have on acute cardiovascular and neurological conditions if clinical efficacy is confirmed.

Looking Ahead

As Nyrada moves through this final Phase I cohort, investors and observers will be keenly watching for the detailed safety and pharmacokinetic data that will inform the design of Phase II trials. The company’s ability to safely administer higher doses over longer periods could be a game-changer in demonstrating Xolatryp’s therapeutic window and dosing flexibility.