Houston-based Coya Therapeutics has started the blinded active-treatment extension phase of the ALSTARS trial (NCT07161999).
The Phase 2, randomized, multi-center, double-blind, placebo-controlled study is evaluating COYA 302 in people with amyotrophic lateral sclerosis. Patients who completed the initial 24-week double-blind phase have entered a 24-week blinded extension during which all participants receive COYA 302; placebo patients are re-randomized to one of two pre-specified dosing regimens to provide up to 48 weeks of data on the investigational therapy.
COYA 302 is a proprietary combination of low-dose interleukin-2 and CTLA-4 Ig intended to enhance regulatory T cell function and to suppress inflammation produced by activated monocytes and macrophages, according to the company.
COYA 302 is investigational and not approved by the U.S. Food and Drug Administration or any other regulatory authority.
Coya Therapeutics is a clinical-stage biotechnology company headquartered in Houston and trades on the Nasdaq under the ticker COYA.
