OPKO Health Launches Phase 1 Trial for MDX2301 COVID-19 Antibody in 80 Adults
OPKO Health’s ModeX has dosed first participants in a Phase 1 study of MDX2301, a tetravalent bispecific antibody engineered to neutralize all known SARS-CoV-2 variants. The trial will enroll 80 adults to evaluate safety and tolerability via IV, IM and SC and is funded by BARDA under contract 75A50123C00056.
1. Phase 1 Study Design
ModeX Therapeutics has begun dosing participants in a randomized, double-blind, placebo-controlled Phase 1 study of MDX2301. The trial will recruit 80 healthy volunteers and adults at high risk for severe COVID-19 to assess safety, tolerability, pharmacokinetics and immunogenicity across intravenous, intramuscular and subcutaneous administration.
2. MDX2301 Antibody Profile
MDX2301 is a first-in-class tetravalent bispecific antibody combining four distinct binding domains in one molecule. It is engineered to neutralize all known SARS-CoV-2 variants, aiming to offer broader and more durable protection than conventional monoclonal antibodies.
3. Federal Funding and Timeline
The study is fully funded by BARDA under contract 75A50123C00056, reflecting federal support for the ModeX multispecific antibody platform. Topline safety and pharmacokinetic data are expected following completion of dosing and initial analysis.