GlobeNewswire·Apr 8, 2026, 8:00 AM ET

OPKO Health's ModeX Therapeutics Initiates Clinical Trial of MDX2301 for the Prevention of COVID-19

ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), has dosed the first participants in a Phase 1 clinical trial for MDX2301, a tetravalent bispecific antibody designed to prevent COVID-19.
MDX2301 is engineered to neutralize all known SARS-CoV-2 variants by combining multiple antibody binding domains into a single molecule for high potency & broad coverage.
The study evaluates the safety, tolerability, pharmacokinetics, anti-drug antibodies, & neutralizing activity of MDX2301 administered via intravenous, intramuscular, or subcutaneous routes.
The randomized, double-blind, placebo-controlled, dose-escalation trial targets 80 participants, including healthy adults & those at high risk for severe COVID-19.
The trial is funded entirely by federal funds from the U.S. Department of Health & Human Services (HHS) Administration for Strategic Preparedness & Response (ASPR), BARDA, under contract number 75A50123C00056.
The study protocol is registered under NCT07445971 & aims to address challenges posed by SARS-CoV-2 evolution, with potential applicability to influenza & emerging viruses.
ModeX Therapeutics is a clinical-stage biopharmaceutical company based in Weston, Massachusetts, developing multispecific biologics for cancer, immunology, & infectious diseases.