Veru Moves Forward with Late-Stage COVID Study Despite FDA Roadblock

Pictured: FDA sign in front of building/Courtesy Sarah Silbiger/Getty Images

Weeks after the FDA rejected Veru’s Emergency Use Authorization (EUA) bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.

Veru will conduct a Phase III study of sabizabulin in hospitalized patients with moderate to severe COVID-19 who are at high risk of developing acute respiratory disease syndrome (ARDS). The drug will also enter a Phase III study in hospitalized influenza patients at risk of ARDS.

This announcement in an SEC filing posted Tuesday comes almost two weeks after the FDA turned down sabizabulin’s EUA. On Mar. 2, the company said the regulator rejected the application but remained open to working with Veru on the drug’s development.

Concurrent with the rejection, the regulator also provided feedback on Veru’s proposed protocol for a confirmatory Phase III study for sabizabulin, stating that the company should provide “appropriate time frames for interim analyses.” This will allow Veru to end the trial promptly “should a strong efficacy signal again be observed,” according to the FDA.

This confirmatory trial could potentially support a new EUA bid or a New Drug Application approval for sabizabulin, according to Veru’s announcement.

Sabizabulin is an investigational oral microtubule disruptor that binds to a protein called tubulin, an integral part of the cell’s cytoskeleton. In COVID-19, sabizabulin inhibits the transport of viral particles within the cells and stops the virus from replicating and assembling itself.

This mechanism of action also has therapeutic potential in cancer because it disables the formation of the mitotic spindle, preventing the uncontrolled division of tumor cells.

However, in Monday’s SEC filing, Veru also announced it was limiting sabizabulin’s clinical development to only infectious disease indications. As a result, it’s discontinuing the Phase III VERACITY study, intended to evaluate the drug in certain prostate cancers.

Cost-Cutting and Realignment

Along with its plans to pursue Phase III in COVID-19, Veru announced Monday initiatives to “refocus its drug development efforts on those drug candidates” most likely to yield “long-term success.”

The company is also implementing cost-cutting measures to conserve cash, including “a reduction in personnel,” the SEC filing read.

As for its pipeline, Veru is also updating a Phase III study of its enobosarm, a selective androgen receptor agonist, in combination with abemaciclib, a CDK 4/6 inhibitor, in specific types of metastatic breast cancer. This drug combo is being developed in partnership with Eli Lilly.

Veru is also developing enobosarm as a monotherapy in bone-only metastatic breast cancers, with a Phase II study currently planned.

Meanwhile, the company is pausing the development of Veru-100, being trialed for prostate cancer, and zuclomiphene, its candidate for hot flashes associated with androgen deprivation therapy.