SAB Biotherapeutics, a clinical-stage biopharmaceutical company with a novel immunotherapy platform, announced on Jan. 24 that its SAB-185 antibody candidate for COVID-19 treatment has been approved for a Phase 3 clinical trial.
The antibody demonstrated positive Phase 2 safety and efficacy data. “It met the criteria for advancement to Phase 3 with Day 3 viral load data from a pre-specified interim data analysis reviewed by the Data Safety Monitoring Board (DSMB) in September,” the company said in a press release.
The company’s immunotherapy platform produces specifically targeted, high-potency, fully human polyclonal antibodies without the need for human donors.
The National Institutes of Health (NIH) announced the beginning of the Phase 2 clinical trial for SAB-185 in April. NIH reported that the trials were part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership
Therapeutic potential for COVID-19 treatment
According to SAB Biotherapeutics’ CEO Eddie J. Sullivan, the positive clinical results are another sign that the antibody could have therapeutic potential for COVID-19 treatment.
“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,” Sullivan said. “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.”
According to SAB Biotherapeutics Chief Medical Officer Dr. Tom Luke: “One striking finding in the Phase 2 study was an analysis of a very small sub-group that showed the pronounced impact of both the low and high doses of SAB-185 on reducing viral loads in COVID patients at high risk of severe disease. While the patient sample size does not support statistical significance, these results suggests that SAB-185 could be efficacious in the current Phase 3 trial, which is being conducted solely in high-risk patients.”