Coya Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track designation to COYA 302 for the treatment of amyotrophic lateral sclerosis.
COYA 302 is an investigational, proprietary biologic combination intended to enhance anti-inflammatory regulatory T cell function and to suppress inflammation from activated monocytes and macrophages; it comprises low dose interleukin-2 and CTLA-4 Ig and is being developed for subcutaneous administration.
The company is conducting the ALSTARS trial, a Phase 2 randomized, multi-center, double-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT07161999) to evaluate the efficacy and safety of COYA 302 in patients with ALS.
Fast Track status can allow more frequent interactions with the FDA, rolling review and potential eligibility for expedited pathways such as accelerated approval or priority review. Coya Therapeutics is headquartered in Houston, Texas and is listed on Nasdaq under the ticker COYA.
