When Veru swiftly wrapped up a phase 3 trial of its COVID treatment last April, expectations bubbled that the company may be able to pry one more emergency use authorization from the FDA.
Those dreams were dashed Friday, after the company announced that regulators declined the EUA route for sabizabulin for now, recommending a confirmatory phase 3 trial instead. The company’s shares slid quickly on the news, down 38% in the first hours of trading from $3.78 to $2.35 per share.
It’s a disappointing ruling for Veru, which reported in April 2022 that its treatment reduced deaths among hospitalized patients with moderate to severe COVID at risk of acute respiratory distress syndrome by 55% compared to placebo. With that data in hand, the company ended its phase 3 trial early to ask regulators for authorization. The company’s share price more than doubled at the time to nearly $10.
Now, the FDA has at least made sure to hand Veru a participation trophy in the form of advice on a confirmatory trial. The company says regulators relayed that it should pay close attention to the time frame for an interim analysis, so that if a strong efficacy signal is once again seen, “the trial could be stopped in an efficient time frame.”
Veru CEO Mitchell Steiner, M.D., is not pleased that regulators are asking the company to run it back, indicating that the FDA found no issues with the phase 3 results that were submitted but remain concerned about “unknown influences, or uncertainties.”
“During our May 10, 2022 pre-EUA meeting with the FDA, the agency indicated that our clinical data package was sufficient to support an EUA submission,” he said in a release. “We lost 510 Americans to COVID-19 just yesterday despite existing FDA-authorized and approved standard of care treatments.”
Veru is the latest example of companies grappling with having missed more lenient EUA terrain. But as cases and hospitalizations of COVID-19 have fallen, the federal government, including the FDA, has signaled a return to business as usual. In October 2022, Eiger BioPharmaceuticals was told its COVID treatment wouldn’t be emergency authorized and that the company should seek full approval.
But for now, Veru says it will play ball. Steiner says that the company “will work closely with the FDA to gain clarity on advancing our sabizabulin program toward a potential new request for an EUA and an NDA submission.”