Final Phase I Clinical Trial Patients Dosed and Discharged
Stock | Nyrada Inc (NYR.ASX) |
---|---|
Release Time | 21 Jul 2025, 8:26 a.m. |
Price Sensitive | Yes |
Final Phase I Clinical Trial Patients Dosed and Discharged
- Final participants in Nyrada's Phase I trial have been dosed and discharged
- Xolatryp appears to have been well tolerated with no adverse safety signals
- Complete safety analysis and pharmacokinetic assessment to be reviewed by Safety Review Committee
Nyrada Inc, a clinical-stage drug discovery and development company, has announced the completion of dosing for all participants in the Phase I clinical trial of its lead candidate Xolatryp. The final cohort of participants have now been dosed and discharged from the trial site, marking a significant milestone in the development of Xolatryp. Throughout the trial, no safety signals, dose-limiting toxicities, or unexpected side effects have been observed. A full safety blood analysis, including pharmacokinetic assessment, will now be reviewed by the trial's Safety Review Committee. Once this data is available, the final clinical study report will be prepared in the coming months. Nyrada's CEO, James Bonnar, commented that the successful completion of dosing across all cohorts supports the company's confidence in the safety profile of Xolatryp and sets the foundation for a Phase II study. Xolatryp is a first-in-class small-molecule therapy being developed by Nyrada for cardioprotection and neuroprotection, with demonstrated preclinical efficacy in treating ischemic stroke, traumatic brain injury, and acute myocardial infarction.
The completion of the Phase I trial and the positive safety profile of Xolatryp set the stage for Nyrada to progress the drug candidate to a Phase II study. The company is anticipating the final clinical study report in the coming months, which will provide the necessary data to inform the design and initiation of the next phase of clinical development.