Veru knows the route that its once-dismissed respiratory distress drug has to take to pacify regulators, but the biotech needs some more cash to hit the road.
That’s according to the company’s latest earnings report, in which Veru said that, despite having clear guidance from the FDA on sabizabulin’s potential approval path, it will seek grants, partnerships and “similar sources” of cash to fund further development. Without an assist, Veru does not expect to advance the asset into a phase 3 study.
The clear-eyed assessment of sabizabulin’s future follows a directive from regulators that the treatment would not be considered under emergency use authorization. It was made more disappointing by the fact that Veru halted a previous phase 3 study early in April 2022 after finding hospitalized patients with moderate to severe COVID-19 had a 55% reduction in death when treated with sabizabulin compared to placebo. Veru said then that the move was a unanimous decision from the study’s data monitoring board.
But the FDA was not convinced, declining the emergency use route in March 2023. CEO Mitchell Steiner, M.D., at the time said the FDA’s reasoning was based on “unknown influences, or uncertainties,” despite agreeing that the submitted phase 3 data passed the primary endpoint.
Veru ultimately put its head down and went back to the drawing board. In September, the company said it had agreed with the FDA on a new single phase 3 study design that widened the use to sabizabulin to acute respiratory distress syndrome stemming from any type of virus, not just COVID-19. The primary endpoint was all-cause mortality at Day 60, and the expected study size was 408 patients. Veru said then that enrollment could begin before 2023 concluded.
Veru closed 2023 with $40.6 million, thanks to a $35.2 million public offering in December. The biotech is also working on a muscle-preserving med for patients on GLP-1s, among other assets. Enobosarm has long been used to treat patients with cancer who had significant muscle loss.