Amyotrophic lateral sclerosis sufferer being helped by a physiotherapist. Credit: CC7 / Shutterstock.com.

Dr Reddy’s Laboratories has signed a licence agreement with Coya Therapeutics to develop and commercialise the investigational combination therapy COYA 302 to treat amyotrophic lateral sclerosis (ALS).

Dr Reddy’s has received an exclusive licence from Coya for the commercialisation of the combination therapy in the European Union (EU), the UK, the US and Canada for ALS.

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COYA 302 is a co-pack kit that includes a combination of low-dose IL-2 and CTLA-4 Ig (abatacept).

Featuring a dual immunomodulatory mechanism of action, the therapy is intended to improve the anti-inflammatory function of regulatory T cells and suppress the inflammation generated by activated monocytes and macrophages.

Dr Reddy’s North America CEO Marc Kikuchi stated: “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.”

Coya holds the right to commercialise the therapy for ALS patients in Japan, Mexico and South America. It will oversee the clinical development of the drug candidate and pursue regulatory approval to treat patients in the US.

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It will receive an upfront payment of $7.5m from Dr Reddy’s, and an additional $4.2m following the first acceptance of an investigational new drug application by the US Food and Drug Administration for the combination therapy.

The company will also secure an additional $4.2m from Dr Reddy’s after dosing the initial subject in COYA 302’s first Phase II trial in the US.

The agreement also covers development and regulatory milestones, with a potential value of $40m if these milestones are met.

Coya can earn milestone payments based on sales, with a maximum of $677.25m linked to tiers of cumulative net sales milestones achieved over multiple years.

Coya will also receive royalties from Dr Reddy’s based on percentage net sales of COYA 302.