Coya Therapeutics has announced the acceptance by the US Food and Drug Administration (FDA) of its investigational new drug (IND) application for COYA 302, paving the way for a Phase II trial to treat amyotrophic lateral sclerosis (ALS).
The Phase II multi-centre, placebo-controlled, double-blind clinical study aims to assess the safety and efficacy of COYA 302 in ALS patients.
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COYA 302 is a biologic combination therapy with a dual immunomodulatory mechanism. It is designed to improve the regulatory T cells’ anti-inflammatory function and reduce inflammation that is caused by activated macrophages and monocytes.
The therapy combines low-dose interleukin-2 and CTLA-4 Ig, intended for subcutaneous administration in ALS patients.
It has not yet received approval from the FDA or any other regulatory bodies. However, the IND acceptance is a significant milestone for Coya Therapeutics, triggering a $4.2m payment from Dr. Reddy’s Laboratories (DRL) following a global agreement signed in December 2023.
DRL and Coya Therapeutics’ agreement was aimed at developing as well as commercialising COYA 302.
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By GlobalDataDRL agreed to pay $7.5m upfront payment to Coya Therapeutics and another $4.2m upon the first FDA acceptance of the IND application to treat ALS.
Additionally, the agreement terms included that DRL will make a payment of another $4.2m to Coya Therapeutics on dosing of the first subject in the first Phase II trial of COYA 302.
Dr Reddy’s Laboratories North America CEO Milan Kalawadia said: “We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study.
“This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energised by the potential of moving a step closer to offering a treatment for patients living with ALS, also known as Lou Gehrig’s disease.”
