FDA Grants Orphan Drug Status to Coya’s T-cell Therapy ALS001

FDA Grants Orphan Drug Status to Coya’s T-cell Therapy ALS001

299062

FDA Grants Orphan Drug Status to Coya’s T-cell Therapy ALS001

Coya Therapeutics’ ALS001, a potential regulatory T-cell (Treg) therapy designed to halt amyotrophic lateral sclerosis (ALS) progression, has been granted an orphan drug designation by the U.S. Food and Drug Administration (FDA). Furthermore, a Phase 2a trial (NCT04055623) testing ALS001 versus a placebo in 12 ALS patients has been completed, and results are expected to be released by the end of the summer, the company announced. “We look forward to showcasing our manufacturing scalability, optimizing…

You must be logged in to read/download the full post.