NIH begins enrolling non-hospitalized volunteers for Phase 2/3 trial of COVID-19 antibody therapeutic

Hundreds of non-hospitalized volunteers are being enrolled in a Phase 2/3 National Institutes of Health (NIH)-run trial of the SAB Biotherapeutics, Inc. creation SAB-185, a polyclonal antibody therapeutic meant to counter COVID-19.

The trial is known as ACTIV-2, part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, and is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). It is meant for adults with mild to moderate cases of COVID-19 enrolled from sites around the world.

SAB-185 has already completed enrollment for Phase 1 and Phase 1b clinical studies and tested positively in preclinical studies. In the latter, it suitably neutralized live SARS-CoV-2 at levels higher than convalescent plasma. Theoretically, the therapeutic will be scalable and, in the hopes of its developers and testers, a more reliable means of intravenous protection. Both high and low therapeutic doses will be tested to see how patients react, but others will be given a placebo.

For these latest trials, SAB-185 — along with several other therapeutics such as BRII-196 and 198, SNG001, AZD7442, and Camostat mesilate, which run the gamut from other antibodies to protease inhibitors — will first enroll 110 participants for a blinded phase two evaluation. Participants will attend clinic or at-home visits with clinicians and be studied for 72 weeks, with all data overseen by an independent Data and Safety Monitoring Board.

While phase two will focus on whether or not the therapeutics are safe and reduce or eliminate COVID-19 symptoms and virus from the body, phase three will determine if the SAB therapy can prevent hospitalization or death within 28 days. That final trial will enroll 421 additional volunteers to receive the SAB agent and another 421 volunteers to take a placebo.