HOUSTON, TX – A Houston-based clinical-stage biotechnology company (NASDAQ: COYA) announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COYA 302, a biologic therapy being developed for the treatment of amyotrophic lateral sclerosis (ALS).
The FDA’s acceptance enables the company to begin a Phase 2 multicenter, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of COYA 302 in ALS patients. The approval also triggers a $4.2 million milestone payment from its partner, Dr. Reddy’s Laboratories Ltd.
According to the company, COYA 302 is a proprietary combination therapy designed to enhance the anti-inflammatory function of regulatory T cells and suppress inflammation from activated monocytes and macrophages. It combines low-dose interleukin-2 and CTLA-4 Ig for subcutaneous administration.
ALS, also known as Lou Gehrig’s disease, is a progressive neurological condition that affects approximately 20,000 people in the United States, with about 5,000 new cases diagnosed annually. The disease currently has no cure, and existing treatments provide limited benefit.
The Houston-based company develops therapies targeting T cell biology for neurodegenerative, metabolic, and autoimmune diseases.
