Veru Pushes Ahead with Final-Stage COVID Trial Despite FDA Setback

Veru has announced its intention to press forward with the late-stage development of sabizabulin, despite the FDA’s rejection of its Emergency Use Authorization (EUA) application for the drug in the treatment of COVID-19. The company is determined to bring this potential therapy to the public despite the challenges it faces.

Veru Pharmaceuticals is set to launch a groundbreaking Phase III trial to assess the efficacy of sabizabulin in hospitalized patients with moderate to severe COVID-19 and influenza, who are at high risk of developing acute respiratory distress syndrome (ARDS). This clinical trial has the potential to revolutionize the way we treat ARDS and provide a much-needed ray of hope in the fight against these life-threatening illnesses.

The U.S. Food and Drug Administration (FDA) recently declined Veru Inc.’s application for an emergency use authorization (EUA) of its experimental drug, sabizabulin. This announcement, which was made in an SEC filing posted on Tuesday, comes almost two weeks after the FDA’s decision. Despite this setback, Veru remains open to working with the regulator to further develop sabizabulin.

The FDA has rejected Veru’s Phase III study protocol for sabizabulin, while providing essential feedback to the company. They suggested that Veru should include appropriate time frames for interim analyses in order to end the trial quickly if a strong efficacy signal is detected. This will enable Veru to reap the rewards of their efforts more quickly.

Veru’s announcement suggests that a confirmatory trial could be a potential stepping stone to obtaining an EUA or NDA approval for sabizabulin. This trial could pave the way to a new era of healthcare, revolutionizing the way we treat certain conditions.

Sabizabulin is an exciting new investigational oral microtubule disruptor that has shown promise in combating COVID-19. By binding to a protein called tubulin, an integral part of the cell’s cytoskeleton, sabizabulin has the potential to inhibit the spread of the virus by blocking viral particles from replicating and assembling within the cells. This innovative technology could become a powerful tool in the fight against the virus.

This mechanism of action holds promise for cancer treatment, as it is capable of disabling the formation of the mitotic spindle, thus preventing the unrestrained division of cancer cells. By blocking this process, the uncontrolled growth of tumors can be halted, providing an avenue for targeted therapies.

Veru Inc. announced in Monday’s SEC filing that it is limiting the clinical development of sabizabulin to infectious disease indications, thus discontinuing the Phase III VERACITY study, which was intended to evaluate the drug in certain prostate cancers. Thus, the company is now focusing solely on developing the drug for infectious diseases.

Cost-Cutting and Realignment

On Monday, Veru announced a bold move to refocus its drug development efforts on those candidates most likely to bring long-term success. This new initiative comes alongside the company’s plans to pursue Phase III in its COVID-19 research, a promising sign of its dedication to providing effective treatments.

The company is taking drastic steps to preserve cash, including reducing staff and other cost-cutting measures. The details were revealed in a recent SEC filing. This move signals a major shift for the company, which could have far-reaching implications for its future.

Veru is making strides in its drug development pipeline, with a Phase III study underway for its enobosarm and abemaciclib combination. Enobosarm is a selective androgen receptor agonist, and abemaciclib is a CDK 4/6 inhibitor. This promising drug combo is being developed in partnership with Eli Lilly, and could offer a potential therapeutic option for people with specific types of metastatic breast cancer.

Veru is currently planning a Phase II study to investigate the potential of its enobosarm as a monotherapy for bone-only metastatic breast cancers. This could be a revolutionary new treatment for this cancer, offering hope to patients worldwide.

Veru Inc. has decided to take a step back from the development of Veru-100, which was being tested for prostate cancer, and zuclomiphene, a potential treatment for hot flashes caused by androgen deprivation therapy. Both medications have been put on hold for the time being.

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