SAB Biotherapeutics, a US-based clinical-stage company, has dosed the first participant of a phase 1 study of SAB-185, its therapeutic candidate for Covid-19, in healthy volunteers.
According to the company, SAB-185 is a fully-human, specifically targeted, and broadly neutralising polyclonal antibody therapeutic candidate. Besides potentially treating Covid-19 patients, the drug candidate can provide protective antibodies that can have significant value in giving protection against the SARS-CoV-2 virus to front-line responders, military, mission-critical staff, and high-risk populations, claimed the company.
SAB-185’s phase 1 study will evaluate its safety as the primary endpoint in 28 healthy participants in a randomised, double-blind, single and multiple ascending dose trial. In mid-August, SAB Biotherapeutics expects to begin a phase 1b clinical trial for the antibody therapeutic candidate for assessing its safety and pharmacological activity of SAB-185 in Covid-19 patients.
Both the phase 1 and phase 1b trials are supported by the US Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
SAB Biotherapeutics said that SAB-185 is targeted specifically to SARS-CoV-2 and has been designed to synergistically work with a patient’s own immune system to neutralise the virus as well as activate other immune system components that are key in enabling the body to fight the disease. The company said that this is especially important with quickly mutating targets like viruses and anti-microbial resistant bacteria.
The polyclonal antibody therapeutic candidate was developed from the company’s DiversitAb Rapid Response Antibody Program in collaboration with the USG.
SAB Biotherapeutics co-founder, president and CEO Eddie Sullivan said: “SAB-185 is supported by recently published preclinical data, which demonstrate that our novel immunotherapy platform can successfully neutralize mutated strains of viruses.
“Further, SAB-185 preclinical data has demonstrated highly-potent neutralizing antibodies to SARS-CoV-2 that are more potent than human convalescent plasma serum samples available against the virus. Taken together, these data suggest that SAB-185 may be effective even as SARS-CoV-2 continues to evolve.”
Last month, SAB Biotherapeutics raised $14m in a Series B funding round which saw the participation of pharma major Merck.