SAB: Positive Topline Data From Discontinued Phase 3 COVID Antibody Trial

 SAB Biotherapeutics Inc 

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 has revealed topline results from the Phase 3 National Institutes of Health's (NIH) ACTIV-2 trial that assessed SAB-185 in non-hospitalized COVID-19 patients at high risk for severe outcomes. 

What Happened: SAB-185 demonstrated benefit in sustained symptom resolution of COVID-19 caused by Omicron compared to participants who received a monoclonal antibody cocktail, REGEN-COV, developed by Regeneron Pharmaceuticals Inc 

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 and Roche Holdings AG 

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.

Data Results: 66% of participants treated with SAB-185 reached full symptom resolution for at least four consecutive days by Day 28, while only 50% of participants on REGEN-COV met this endpoint (p=0.010).

The median time to symptom resolution for at least four consecutive days was seven days shorter for SAB-185. 

Also, the median time to symptom resolution for at least two consecutive days was six days shorter for SAB-185 than those treated with REGEN-COV (p=0.021). 

In the non-Omicron population, the median time to symptom resolution for at least four consecutive days was seven days shorter for SAB-185, and the median time to symptom resolution for at least two consecutive days was four days shorter for SAB-185 than REGEN-COV. 

However, neither of these analyses met statistical significance.

Why It Matters: Last March, SAB Biotherapeutics said that due to low hospitalization and death rates in the trial, the National Institutes of Health's NIH ACTIV-2 Program discontinued enrollment in its Phase 3 COVID-19 trial.

The sponsors concluded that the potential efficacy of SAB 185 would not be possible to demonstrate statistically significant clinical efficacy with the existing study design.

"The ACTIV-2 data further validates the potential of SAB's platform. It shows that the DiversitAb™ platform can open the door to treatments that are potentially more effective and potent and which remain efficacious over longer periods versus monoclonal antibodies," said Eddie J. Sullivan, co-founder, President & CEO of SAB Biotherapeutics

https://www.benzinga.com/general/biotech/23/04/32004894/exclusive-sab-biotherapeutics-releases-topline-data-from-discontinued-covid-antibody-trial