Topline results were announced from a phase 3 study evaluating SAB-185, a human IgG1 (polyclonal) antibody therapeutic candidate, for the treatment of nonhospitalized patients with COVID-19 at high risk for severe outcomes.
The National Institutes of Health (NIH) ACTIV-2 clinical trial (ClinicalTrials.gov Identifier: NCT04518410) was initiated to evaluate the safety and efficacy of different therapies to reduce the duration of symptoms of COVID-19 in adult outpatients.
An analysis of data showed that 66% of patients treated with SAB-185 reached full symptom resolution for at least 4 days by day 28 compared with 50% of those who received the monoclonal antibody combination REGEN-COV® (casirivimab and imdevimab) (P =.01).
Median time to symptom resolution for at least 2 consecutive days was observed to be shorter with SAB-185 vs REGEN-COV:
- Non-Omicron population: 15 days vs 19 days (not statistically significant);
- Omicron population: 17 days vs 23 days (P =.021).
Similarly, symptom resolution for at least 4 consecutive days occurred sooner with SAB-185 vs REGEN-COV:
- Non-Omicron population: 16 days vs 23 days (not statistically significant);
- Omicron population: 18 days vs 25 days (P =.01).
The primary endpoint of the study, a composite of all-cause hospitalizations and deaths, was found to be inconclusive due to the small number of clinical events. Treatment-emergent adverse events (grade 3 or higher) were reported to be similar between groups.
SAB Biotherapeutics announces positive results from phase 3 trial of SAB-185 in patients with COVID-19 at high-risk for severe complications. News release. SAB Biotherapeutics. April 26, 2023. https://www.globenewswire.com/news-release/2023/04/26/2655066/0/en/SAB-Biotherapeutics-Announces-Positive-Results-from-Phase-3-Trial-of-SAB-185-in-Patients-with-COVID-19-at-High-Risk-for-Severe-Complications.html.