Biotechnology company Coya Therapeutics Inc (NASDAQ: COYA) announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COYA 302, enabling the initiation of a Phase 2 multicenter, double-blind, placebo-controlled study in amyotrophic lateral sclerosis (ALS). The clearance also triggers a USD4.2m milestone payment to Coya from Dr. Reddy's Laboratories Ltd (NYSE: RDY).

COYA 302 is a proprietary biologic combination therapy designed to enhance regulatory T cell (Treg) function while suppressing pro-inflammatory monocytes and macrophages. The therapy combines low-dose interleukin-2 and CTLA-4 Ig, and is being developed for subcutaneous administration in ALS patients.

ALS, also known as Lou Gehrig's Disease, affects roughly 20,000 people in the US with around 5,000 new diagnoses annually. The progressive neurodegenerative condition leads to loss of motor neuron function, muscle atrophy and eventual respiratory failure, with most patients dying within three to five years of symptom onset. Current therapies offer only limited benefit.

Headquartered in Houston, Coya is advancing a pipeline of Treg-focused therapies spanning biologics, exosomes and autologous cell therapies targeting neurodegenerative, autoimmune and metabolic diseases. Partner Dr. Reddy's, based in Hyderabad, India, operates globally across APIs, generics, biosimilars and specialty medicines.