• Safety Review Committee approved progression to second cohort
• NYR-BI03 shows neuroprotective and cardioprotective effects in preclinical studies
• Phase I trial expected to complete in Q3 2025

Nyrada Inc. has provided an update on its Phase I clinical trial of drug candidate NYR-BI03, a small molecule first-in-class drug for neuroprotection and cardioprotection indications. The company's Safety Review Committee has reviewed safety and pharmacokinetic data from the first cohort in the clinical trial and raised no issues, enabling the trial to progress to the second cohort. Recruitment for the second cohort is already underway, and final Phase I trial readouts are expected in Q3 2025. Nyrada's lead drug candidate NYR-BI03 has shown promising results in preclinical studies, including a statistically significant neuroprotective effect in a stroke study, an 86% cardioprotective effect in a coronary heart disease study, and a statistically significant neuroprotective effect in a traumatic brain injury study. The Phase I trial is a double-blind, placebo-controlled, randomized, first-in-human, dose escalation study to assess the safety, tolerability, and pharmacokinetics of NYR-BI03 in healthy participants when administered as a 3-hour intravenous infusion.

Nyrada expects to complete its Phase I clinical trial of NYR-BI03 in the third quarter of 2025.