DRL partners with Coya Therapeutics to develop nerve disorder therapy

Dr Reddy’s Laboratories (DRL) said on Wednesday that it has entered into an exclusive collaboration with US-based Coya Therapeutics for the development and commercialisation of an investigational combination therapy named COYA 302 for a neurological disorder.

Amyotrophic Lateral Sclerosis (ALS) is a fatal neurological disorder characterised by progressive degeneration of nerve cells in the spinal cord and brain.

Under the agreement, Dr Reddy’s will obtain commercialisation rights for COYA 302 in the United States, Canada, the European Union, and the United Kingdom, for patients with ALS. Coya will be responsible for development, including the conduct of the Phase 2 clinical trial and for obtaining regulatory approval in the United States. In early 2023, Coya entered into an in-licensing agreement with Dr Reddy’s to license its proposed biosimilar abatacept for the development and commercialisation of COYA 302.

DRL 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). In addition, Dr Reddy’s will pay Coya royalties based on a percentage net sales of COYA 302 ranging from low to middle teens. Coya is not a related party to Dr Reddy’s or its promoters/promoter group.

Howard Berman, Chief Executive Officer of Coya, observed: “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.”