Therapy Areas: AIDS & HIV
SAB Biotherapeutics doses first COVID-19 patient under Phase 3 SAB-185 NIH ACTIV-2 trial
5 October 2021 -

Biopharmaceutical company SAB Biotherapeutics (SAB) said on Monday that it has dosed the first patient with SAB-185 in the Phase 3 ACTIV-2 COVID-19 trial led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) in collaboration with the AIDS Clinical Trials Group.

According to the company, SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. The lower dose of SAB-185 will be assessed in Phase 3.

In addition, the company revealed SAB-185 is the second agent to upgrade to Phase 3 and the first polyclonal antibody therapeutic candidate in ACTIV-2, which is evaluating multiple investigational agents to treat early symptomatic COVID-19 in non-hospitalized individuals.

SAB-185 advanced from Phase 2 to the Phase 3 portion of the ACTIV-2 trial based on meeting pre-defined graduation criteria. Both the lower and higher doses of SAB-185 tested in Phase 2 met the pre-defined efficacy goal for advancement to Phase 3 and appeared safe.

Under the Phase 3 portion of the ACTIV-2 trial, the company is enrolling approximately 600 participants to receive the investigational agent SAB-185 and 600 to receive an active comparator. The primary outcome measures of the Phase 3 trial include safety and non-inferiority for the prevention of a composite endpoint of either hospitalization or death from any cause through study day 28.

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