The US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application from Coya Therapeutics for COYA 302, enabling the company to begin a phase 2 clinical trial in patients with amyotrophic lateral sclerosis (ALS).
The study will assess the safety and efficacy of COYA 302, a biologic therapy designed to regulate the immune system. ALS, also known as Lou Gehrig’s disease, is a progressive neurological condition that affects nerve cells controlling muscle movement. Around 20,000 people in the US live with the condition and most patients die from respiratory failure within three to five years of symptom onset, meaning new therapeutics are of high medical need.
COYA 302 combines two components: low-dose interleukin-2, intended to boost the activity of regulatory T cells that calm inflammation and CTLA-4 Ig, which reduces immune activation by monocytes and macrophages. By targeting both pathways, the treatment aims to slow inflammation linked to nerve damage.
Arun Swaminathan, CEO of Coya Therapeutics, said: “The FDA’s acceptance of this IND marks a pivotal moment in Coya’s journey. We are now preparing to initiate a multicentre phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS.”
The FDA decision also onsets a $4.2m milestone payment to Coya from its partner Dr Reddy’s Laboratories.
