SAB Biotherapeutics Announces Update to the Phase 3 NIH ACTIV-2 Trial Design Evaluating SAB-185 for Treatment of COVID-19

Rhea-AI Summary

SAB Biotherapeutics updates its Phase 3 ACTIV-2 trial for SAB-185, now pivoting to a placebo-controlled design to evaluate its efficacy against the Omicron variant of COVID-19. The trial, sponsored by the NIAID, will include an additional 800 participants, bringing the total to approximately 1,200. SAB-185 demonstrates neutralizing activity against COVID variants, including Omicron. The trial's design change reflects the need for effective treatments as Omicron now comprises about 95% of new cases in the US, aiming to restart data collection with minimal disruption.

Positive

• Study design updated to placebo-controlled, enhancing rigor of trial results.
• SAB-185 shows continued neutralizing ability against COVID variants, including Omicron.
• Total enrollment increased to around 1,200 participants, supporting robust data collection.

Negative

• Switching from an active comparator to placebo may raise concerns regarding the effectiveness of SAB-185 compared to existing treatments.

ACTIV-2 Phase 3 trial continuing as placebo-controlled study in Omicron variant COVID participants

SIOUX FALLS, S.D., Feb. 25, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (SAB) (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced an update to the design of the ongoing Phase 3 ACTIV-2 trial evaluating the clinical efficacy and safety of SAB-185 for the treatment of participants with mild-moderate COVID infections at higher risk for progression to hospitalization. The Phase 3 trial had been designed as an open-label, randomized non-inferiority study comparing SAB-185 to an active comparator—a monoclonal antibody cocktail (casirivimab and imdevimab) authorized for treatment of COVID-19. Going forward, the active comparator will be replaced with a placebo.

The trial is sponsored 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. SAB-185 is a fully-human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate. In vitro testing has confirmed that SAB-185 retains neutralizing activity against COVID variants of concern, including the Omicron variant.

“We welcome the fast action to modify the ACTIV-2 Phase 3 trial once it became clear that the active comparator was not effective against the Omicron variant, which now represents about 95% of new COVID-19 cases in the US,” said Eddie J. Sullivan, Ph.D., co-founder, President, and Chief Executive Officer of SAB Biotherapeutics. “SAB-185 is designed to be a broadly neutralizing therapeutic, and in laboratory studies, it has demonstrated continuing neutralizing ability against Omicron and other COVID variants. We are encouraged that NIH chose to update and continue this Phase 3 study as a placebo-controlled trial.”

The ACTIV-2 trial is designed to rapidly assess potential new therapies for COVID-19 utilizing an adaptive platform trial design. Under the new update, the Phase 3 trial design is amended to pivot to a blinded, randomized, placebo-controlled superiority trial. Participants in both study arms will be encouraged to access standard of care therapy for the treatment of COVID-19 if available to them outside the trial.

The study endpoints remain unchanged. Since the trial is focusing on Omicron and potential future SARS-CoV-2 variants, an additional 800 participants will be enrolled to supplement the approximately 400 participants already participating in the SAB-185 Phase 3 trial (of the more than 700 total COVID-19 participants who had been enrolled prior to the study redesign). The trial is expected to restart in the coming weeks, allowing for minimal disruption of data collection.

For more information on the Phase 3 ACTIV-2 trial, visit clinicaltrials.gov (Identifier NCT04518410).

Direct support for the development of SAB-185 is provided by the US Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) on behalf of the Office of the Assistant Secretary of Defense for Health Affairs (OASD-HA), and the Defense Health Agency (DHA) and by the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, under contract number MCDC 2019-448.

About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine™ that produce fully human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer. SAB’s versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, human polyclonal immunotherapies. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: https://www.sabbiotherapeutics.com/ and follow @SABBantibody on Twitter.

Contacts:
Melissa Ullerich
+1 605-679-4609
mullerich@sabbiotherapeutics.com

Courtney Turiano (investors)
Stern IR
212-698-8687
Courtney.Turiano@sternir.com

Forward-Looking Statements
Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including the development of SAB-185 and the efficacy of SAB-185.

These statements are based on the current expectations of SAB and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict, will differ from assumption and are beyond the control of SAB. A further description of risks and uncertainties can be found in the prospectus filed by SAB Biotherapeutics, Inc. on December 29, 2021, including in the sections thereof captioned “Risk Factors” as well as in its subsequent reports on Form 10-K, 10-Q and Form 8-K, all of which will be filed with the U.S. Securities and Exchange Commission and available at https://www.sec.gov/

FAQ

What is the purpose of the Phase 3 ACTIV-2 trial involving SABS?

The Phase 3 ACTIV-2 trial aims to evaluate the safety and efficacy of SAB-185 for treating mild-moderate COVID-19 infections, particularly for patients at risk of hospitalization.

When will the Phase 3 ACTIV-2 trial for SAB-185 restart?

The trial is expected to restart in the coming weeks, with minimal disruption to data collection.

How many participants are involved in the SAB-185 trial?

Approximately 1,200 participants are expected to be enrolled in the SAB-185 trial following the design update.

How does SAB-185 perform against the Omicron variant?

SAB-185 has demonstrated neutralizing activity against the Omicron variant in laboratory studies.

What changes were made to the trial design for SAB-185?

The trial design has been amended to a blinded, randomized, placebo-controlled superiority trial, replacing the active comparator.