Oct. 4, 2021

Based on data that shows it’s safe and effective, the COVID-19 therapeutic developed by Sioux Falls-based SAB Biotherapeutics has moved into phase three of clinical trials.

It’s part of the broader ACTIV-2 Trial being conducted by the National Institute of Allergy and Infectious Diseases, and the National Institutes of Health, working with the AIDS Clinical Trials Group.

SAB’s therapeutic, called SAB-185, is the second treatment in the trial to advance to phase three and the only one that uses polyclonal antibodies. SAB’s first-of-its-kind technology produces fully human, polyclonal antibodies that have the ability to broadly neutralize viruses.

“Advancement of SAB-185 to phase three is a major milestone for our DiversitAb immunotherapy platform, which uniquely produces fully human, targeted polyclonal antibodies that have broad applicability to treating other infectious diseases and medical conditions,” Eddie Sullivan, co-founder, president and CEO of SAB Biotherapeutics, said in a statement.

“The recent publication of nonclinical data demonstrating SAB-185’s potent neutralization of multiple emerging SARS-CoV-2 variants provided additional evidence that SAB-185 has the potential to become a valuable therapy for mild to moderate COVID-19. We now look forward to the completion of the phase three trial and, if successful, the opportunity to make SAB-185 widely available to the many COVID-19 patients battling this persistent and evolving disease.”

Both the low and high doses of SAB-185 tested in phase two were deemed effective enough to advance to phase three and appeared safe at the interim analysis, SAB reported. NIAID and SAB researchers are finalizing the preferred dose to assess in phase three.

The phase three portion of the ACTIV-2 trial is a randomized, unblinded, active comparator-controlled adaptive platform study that will assess the clinical safety and efficacy of SAB-185 compared to active control monoclonal antibody treatment in people with mild to moderate COVID-19 who are at higher risk for progression to hospitalization, enrolling approximately 1,200 total participants. The trial will measure safety and the treatment’s ability to prevent hospitalization or death.

SAB is on track to become publicly traded on the Nasdaq yet this year. Big Cypress Acquisition Corp., which is merging with SAB to bring it to the public market, has scheduled an Oct. 20 vote of its shareholders.

The latest news follows a recent announcement of more than $60 million in federal funding directed to SAB.

SAB awarded $60M more in government funding for COVID-19 therapeutic