Early wrap up for Veru's COVID trial spurs doubling of share price, race to regulators

Veru is quitting while it's ahead, closing up shop early on a phase 3 trial for a COVID-19 treatment in the sickest patients after initial data found that it reduced deaths by more than 50%. 

The decision came unanimously from Veru's independent safety monitoring committee after sabizabulin was found to reduce deaths by 55% compared to placebo among hospitalized patients with moderate to severe COVID, the company said Monday. The quality of the initial analysis has Veru racing to regulators to make a case for emergency use authorization.

As one might expect, Wall Street grinned at the news and rewarded Veru with a whopping share rise of nearly 130% from $2.60 to $9.95 around 11:11 a.m. ET. 

The study was a randomized, double-blinded phase 3 study among 210 hospitalized COVID patients with moderate to severe disease. Patients were able to receive the standard of care, dexamethasone and Gilead's Veklury, although no difference in effectiveness was seen based on that care, said Veru CEO Mitch Steiner, M.D., in an investor call. COVID infections in the trial included both delta and omicron variants but data isn’t yet available on potential differences in efficacy between the two. 

The mortality rate among the placebo group was 45%—indicative of disease severity—compared to 20% for the treatment arm. 

Sabizabulin is a small molecule that tackles replication of a virus by targeting cells’ microtubules, which act as railway tracks. Usually, a virus hijacks those microtubules to access the nucleus and join in replication. By stymying this effort, the virus can’t replicate. Because this mechanism is so essential to basic virology, the treatment is unlikely to be variant-dependent, according to Steiner.

There’s currently no authorized or approved COVID-19 treatment for severely hospitalized patients, so Veru could find a lucrative niche in the treatment chain if authorized. The next best thing, Veklury, was approved in late 2020 to treat hospitalized patients with mild-to-moderate COVID. 

Veru will now head to regulators for the coveted authorization. Steiner said the company would likely meet with the FDA this month. Sabizabulin received fast track designation in January. The company is also consulting with the Biomedical Advanced Research and Development Authority and other U.S. agencies to discuss the advance purchasing of the drug, although it's unknown how dwindling federal COVID funds may impact the government’s purchasing options.

Regardless, Steiner said governments’ contributions will likely just be “priming the pump”, given the primary buyer will ultimately be hospitals. Veru expects that governments will also purchase enough doses for stockpiling. 

“[S]tockpiling so that they’re ready for the next epidemic is probably going to be another piece of the revenue that we can count on for the company,” he said.

Veru’s news comes as treatment options remain scattered and inconsistent in the U.S. Recent authorizations for Pfizer’s Paxlovid, Merck’s molnupiravir and AstraZeneca’s Evusheld have boosted supply, but have been hard to obtain for some. Other options, like GlaxoSmithKline and Vir’s sotrovimab, have fallen by the wayside as stunted efficacy versus the omicron BA.2 subvariant has led the FDA to restrict use nationwide

Even if these treatment options were more abundant, there remains a clinical—and subsequently economic—gap to fill for the sickest patients. That’s where Veru hopes it can make an impact. 

The company is also testing sabizabulin in patients with prostate and breast cancer, with the drug currently in a phase 3 trial for the former indication as well. While the company is now focused on bringing the drug to market for COVID, Steiner said the oncology program will continue to chug along as planned.