SAB vows to plow ahead with COVID-19 therapy after NIH drops out

SAB Biotherapeutics is hoping to continue work on its COVID-19 antibody treatment after the National Institutes of Health (NIH) shut down a funded phase 3 clinical trial when the omicron wave slowed earlier this year.

With NIH out of the picture, SAB is hoping to forge ahead with SAB-185, the company said in a fourth-quarter earnings update earlier this week. The company is expecting a full data readout in mid-2022 from a previous phase 2.

SAB said the treatment, which is derived from bovine antibodies, could be used for immunocompromised patients or to help battle future variants of the coronavirus. But the NIH's shutdown of ACTIV-2 leaves the study without enough data to determine statistical significance. SAB-185 was being evaluated in patients with mild to moderate infections at higher risk of progression to hospitalization.

Analysts from Chardan noted that the NIH’s position “does not imply a lack of efficacy for SAB-185,” in a Friday note.

The company is now evaluating ways to continue studying the therapy in COVID-19 patients, especially in targeted patient populations who may benefit. SAB specifically highlighted the potential for use as a prophylactic or therapeutic in high-risk populations. The company is also considering developing an injectable formulation.

SAB says data collected on the candidate already support continued advancement. SAB-185 cleared a phase 2 and was advanced to the phase 3 trial and was shown to neutralize the omicron variant in tests conducted in vitro.

As for its financials, SAB said existing cash and government funding already received through Dec. 31, 2021, will provide a runway into the third quarter of 2023. The company tallied $57.2 million in research expenses for 2021 compared to $27.9 million the year before.