SAB Biotherapeutics, Inc. (SABS), a clinical-stage, biopharmaceutical company focused on human polyclonal antibodies, reported Monday positive Phase 2 safety and efficacy data of SAB-185.
The data demonstrated that SAB-185 met the criteria required for advancement to Phase 3 in the US National Institutes of Health or NIH COVID-19 ACTIV-2 Trial.
SAB-185 is a fully-human, specifically targeted, broadly neutralizing polyclonal antibody candidate for the treatment of high-risk non-hospitalized patients with mild to moderate COVID-19. The company noted that SAB-185’s targeted, highly potent and fully-human polyclonal antibodies have demonstrated neutralization of SARS-CoV-2 viral variants, including Delta and Omicron.
The ACTIV-2 Phase 2 trial was designed to test whether SAB-185 met the pre-specified virology criteria necessary to advance to Phase 3.
It is currently being evaluated in the Phase 3 NIH-Sponsored ACTIV-2 COVID trial of high-risk patients following positive Data Safety Monitoring Board or DSMB review of interim Phase 2 safety and efficacy data in September.
Both the Phase 2 and Phase 3 ACTIV-2 trials are sponsored and conducted by the National Institute of Allergy and Infectious Diseases or NIAID, part of the NIH, in collaboration with the AIDS Clinical Trials Group.
Eddie Sullivan, co-founder, President, and Chief Executive Officer of SAB Biotherapeutics, said, “SAB-185 appeared safe and achieved a key virologic efficacy criterion, despite a change in protocol early in the study that resulted in enrollment comprised predominantly of patients at low-risk of severe disease. The original protocol focused on high-risk patients, who are most likely to benefit from treatment with SAB-185. Data from a very small subset of high-risk patients treated with SAB-185 showed sharp declines in viral load compared to high-risk placebo controls. In the Phase 3 trial, SAB-185 is being assessed in a high-risk population.”
The Phase 3 study in high-risk patients is more than 50% enrolled, and the company said it expects results later this year.
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