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OPKO Health's ModeX begins phase 1 trial of COVID-19 prevention drug

April 8, 2026 8:03 AM

ModeX Therapeutics, a subsidiary of OPKO Health (NASDAQ: OPK), has initiated a Phase 1 clinical trial for MDX2301, a drug designed to prevent COVID-19. The company announced that the first participants have been dosed in the study.

MDX2301 is described as a tetravalent bispecific antibody that aims to neutralize known variants of SARS-CoV-2. The trial will evaluate the drug's safety and tolerability when administered through intravenous, intramuscular, or subcutaneous routes in healthy volunteers and adults at high risk for severe COVID-19.

The randomized, double-blind, placebo-controlled study is expected to enroll 80 participants. The trial will also assess pharmacokinetics, anti-drug antibodies, and neutralizing activity of the experimental treatment.

"Despite progress in prevention and treatment, COVID-19 poses a significant public health risk, particularly for vulnerable populations," said John Mascola, Chief Scientific Officer of ModeX Therapeutics.

Gary Nabel, President and CEO of ModeX and Chief Innovation Officer of OPKO Health, stated that MDX2301 "neutralizes all known variants of the virus and has potential to protect such patients."

The trial is funded by the U.S. Department of Health and Human Services Administration for Strategic Preparedness and Response, specifically the Biomedical Advanced Research and Development Authority, under contract number 75A50123C00056.

ModeX Therapeutics develops multispecific biologics for cancer, immunology, and infectious diseases. The company is based in Weston, Massachusetts.

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