SAB Biotherapeutics ( SABS Quick Quote SABS - Free Report) reported data from the phase II study evaluating SAB-185, its intravenously administered polyclonal antibody treatment of high-risk non-hospitalized patients with mild-to-moderate COVID-19.
Data from the phase II study demonstrated the safety and efficacy of SAB-185 in both high as well as low-dose arms. SAB Biotherapeutics’ antibody treatment has demonstrated neutralization in viral COVID-19 variants, including the Delta and Omicron variants.
SAB Biotherapeutics has already advanced the antibody treatment therapy to a phase III study, following a positive review of the interim phase II data by the Data Safety Monitoring Board last September. The phase III study is evaluating SAB-185 against an active control monoclonal antibody treatment in two equal groups of patients having mild-to-moderate COVID-19 who are at high risk for hospitalization.
In the trailing 12 months, shares of SAB Biotherapeutics have plunged 41.3% in comparison with the
industry’s 39.4% decline. Image Source: Zacks Investment Research
We note that both the studies are being sponsored and conducted by the U.S. National Institutes of Health.
Although the phase II study evaluated the therapy in both low-risk and high-risk patients, overall high-risk patients in the study treated with SAB-185 constituted only about 12.5% of phase II study participants. While treatment with SAB-185 in high-risk patients showed a sharp decline in viral load compared to placebo, the small sample size makes it difficult to assess whether the study achieved statistically significant results in the high-risk population.
While the phase II study achieved the key virology efficacy measure that was required to advance SAB-185 to a phase III study, it did not achieve statistical significance in other endpoints.
The phase III study has already completed more than 50% of its targeted enrolment.
SAB-185 has been developed by SAB Biotherapeutics with direct support from the U.S. government.
While SAB Biotherapeutics is yet to file a regulatory application for SAB-185 in the United States, the target market is currently dominated by monoclonal antibodies developed by
Eli Lilly ( LLY Quick Quote LLY - Free Report) , GlaxoSmithKline ( GSK Quick Quote GSK - Free Report) and Regeneron ( REGN Quick Quote REGN - Free Report) .
GlaxoSmithKline and partner Vir Biotechnology have developed their own monoclonal antibody, sotrovimab, which was granted emergency use authorization (EUA) by the FDA last May to treat mild-to-moderate COVID-19 in high-risk adults and pediatric patients (aged at least 12 years and weighing at least 40 kg). Sotrovimab is administered intravenously and marketed by GlaxoSmithKline under the trade name Xevudy.
Both Regeneron and Eli Lilly market their respective antibody cocktails. However, both companies faced a setback on Monday when the FDA
revised the EUA granted to the antibody cocktails developed by Lilly and Regeneron, limiting their use to treat COVID-19 variants against which these cocktail treatments are effective.
The regulatory agency cited that the antibody cocktails of Lilly and Regeneron are unlikely to be effective against the Omicron variant, which is currently the dominating variant in the country.
SAB Biotherapeutics currently carries a Zacks Rank #4 (Sell).
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