FDA Accepts IND for Biologic Combination Therapy for ALS

The Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for COYA 302 (Coya Therapeutics, Houston, TX), a biologic combination therapy under investigation for the treatment of people with amyotrophic lateral sclerosis (ALS). With this acceptance, Coya Therapeutics announced that the company is preparing to launch a multicenter phase 2 clinical trial to assess the safety and efficacy of the therapy.

COYA 302 is designed as a dual immunomodulatory therapy delivered subcutaneously, comprising a proprietary combination of low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig. The therapy is intended to enhance the activity of regulatory T cells, which exert anti-inflammatory effects, while suppressing proinflammatory responses from activated monocytes and macrophages.

Source: Coya Therapeutics. Coya Therapeutics announces FDA acceptance of Investigational New Drug (IND) application for COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS). August 25, 2025. Accessed August 27, 2025. https://prnmedia.prnewswire.com/news-releases/coya-therapeutics-announces-fda-acceptance-of-investigational-new-drug-ind-application-for-coya-302-for-the-treatment-of-amyotrophic-lateral-sclerosis-als-302537194.html.