COYA 302

Coya is a small Nasdaq-listed company in Houston. Its partner Dr. Reddy's Laboratories supplies the CTLA4-Ig part of the combination, pays milestone fees and invested in Coya in January 2026. Coya says its cash should last into the second half of 2027, beyond the expected ALSTARS results.

In ALS, regulatory T cells (Tregs), which normally keep inflammation in check, weaken as the disease progresses. COYA 302 pairs a low dose of interleukin-2, which strengthens Tregs, with CTLA4-Ig (a copy of the arthritis drug abatacept), which calms activated immune cells. The idea is that the two together reduce harmful inflammation around motor nerves.

ALSTARS is a randomised, double-blind, placebo-controlled trial at about 25 sites in the US and Canada. Dosing began in December 2025 and enrolment of 120 people was completed in October 2026. The FDA granted Fast Track status in May 2026. Coya first called ALSTARS a Phase 2 trial; by October 2026 it was calling it Phase 2/3. Placebo patients switch to the drug after 24 weeks.

In a Houston Methodist pilot study, 4 people with ALS received low-dose IL-2 and CTLA4-Ig for 48 weeks. Before treatment they lost about 1.1 ALSFRS-R points a month; over the first 24 weeks their average score was stable, and over 48 weeks they lost about 0.13 points a month, with one person improving and three declining by about 0.47 points a month. Treg function improved and some markers of inflammation fell, though the nerve-damage marker NfL did not change on average. With only 4 people and no placebo group this is a signal at most; ALSTARS is the first real test.

This is the most favourable result reported. See all key studies for the full picture.

ALSTARS enrolled adults with ALS at sites in the US and Canada. In 2026 Coya loosened the rules to allow people on blood-pressure medicines and people with controlled autoimmune diseases. Both medicines are given as injections under the skin.

When enrolment finished in October 2026, Coya said it expects topline results in early Q2 2027. Earlier in 2026 it had guided to Q1 2027. People who finish the blinded part can move into an open-label extension starting November 2026.

ALSTARS is no longer enrolling new people. Coya plans an open-label extension for people already in the trial, starting November 2026. We found no expanded access programme.

• ALSTARS (Phase 2/3) (NCT07161999) active not recruiting · USA, Canada