Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Hyderabad-based Dr. Reddy’s Laboratories, and Coya Therapeutics, Inc. have entered into a development and license agreement for the development and commercialisation of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Under the terms of the Agreement, Coya has granted Dr. Reddy’s an exclusive license to commercialise COYA 302, a proprietary co-pack kit containing combination of low dose IL-2 and CTLA-4 Ig (abatacept) in the United States, Canada, the European Union and the United Kingdom for ALS. Coya retains the right to commercialise COYA 302 for patients with amyotrophic lateral sclerosis (ALS) in Japan, Mexico, and each country in South America.

Coya will have responsibility for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 for patients with ALS in the United States.

Dr. Reddy’s will make a $7.5 million upfront payment to Coya. Upon the first FDA acceptance of an investigational new drug (IND) application for COYA 302 for the treatment of ALS, Dr. Reddy’s will pay Coya an additional $4.2 million.

Upon dosing of the first patient in the first Phase 2 trial of COYA 302 for the treatment of ALS in the United States, Dr. Reddy’s will pay Coya an additional $4.2 million. Coya anticipates that the IND filing will be made in the first half of 2024.

The Agreement also includes development and regulatory milestones up to $40 million should all such development and regulatory milestones be achieved. Additionally, Coya is eligible to receive sales-based milestone payments of up to $677.25 million linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement subject to product commercial exclusivity).