Dr. Reddy’s Laboratories has entered into a development and license agreement with Coya Therapeutics, Inc. for the development and commercialization of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Coya has granted Dr. Reddy’s an exclusive license to commercialize COYA 302, a co-pack kit containing combination of low dose IL-2 and CTLA-4 Ig (abatacept) in the U.S., Canada, the EU, and the United Kingdom.

The agreement is in addition to the in-licensing agreement with Dr. Reddy’s signed in early 2023. Coya retains the right to commercialize COYA 302 for patients with 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 in the U.S.

Dr. Reddy’s will pay $7.5 million upfront and an additional $4.2 million upon the first FDA acceptance of an investigational new drug (IND) application for COYA 302 for the treatment of ALS.

Marc Kikuchi, CEO of Dr. Reddy’s North America, said, “Patients with ALS, commonly known as Lou Gehrig’s disease, have very few treatment options. We are pleased to partner with Coya Therapeutics on this investigational therapy which may have a unique place in treating patients with this progressive neurodegenerative disease. With this promising biologic product, we hope to reach many more patients around the world in keeping with our aim of serving over 1.5 billion patients by 2030. Dr. Reddy’s biosimilars/biologics business is part of our key strategic initiatives expected to drive both near-term and long-term growth.”

Howard Berman, CEO of Coya said, “The Coya team is delighted to enter this exciting partnership with Dr. Reddy’s, a world class organization that defines excellence in innovation and commercialization. While the agreement provides the financial resources to execute on the Phase 2 clinical program for COYA 302 in ALS, the strategic value of the partnership contributes much more than capital. We will benefit from and leverage Dr. Reddy’s manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan together for the future of COYA 302 in ALS, a devastating disease with a high unmet need.”