NYR Price sensitive 14 Jul 2025, 9:14 AM

Final Nyrada Phase I Clinical Trial Cohort to Commence

Nyrada Inc

Final Nyrada Phase I Clinical Trial Cohort to Commence

Key points

  • Cohort 6 approved to commence, marking the final stage of Nyrada's Phase I clinical trial of Xolatryp
  • No safety concerns were identified in Cohort 5, with no dose-limiting toxicities or adverse effects reported
  • Cohort 5 received the highest concentration to date via a 3-hour intravenous infusion

Full summary

Nyrada Inc (ASX:NYR), a clinical-stage drug discovery and development company focused on innovative Transient Receptor Potential Canonical (TRPC) ion channel inhibitors, today provides an update on its Phase I clinical trial. Nyrada is pleased to announce the commencement of Cohort 6, the final dosing group in its Phase I clinical trial of Xolatryp. This milestone follows a review by the Safety Review Committee (SRC), which evaluated safety and pharmacokinetic data from Cohort 5. Participants in Cohort 5 received Xolatryp at a human equivalent dose and exposure duration matching that used in the May 2025 3-hour preclinical cardiac efficacy study, where a 42% level of cardioprotection was observed. This dose level was approximately 2.5 times higher than that administered in Cohort 4. Importantly, no safety signals, dose-limiting toxicities, or unexpected adverse effects were reported, consistent with findings from earlier cohorts. With SRC clearance secured, the study now progresses to Cohort 6, where participants will receive the same concentration of Xolatryp as in Cohort 5, but for a 6-hour infusion period. This effectively doubles the total dose. This extended exposure is expected to generate critical data that will provide Nyrada with greater flexibility in designing its upcoming Phase II study.

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