Veru announces FDA comments on Phase 3 study protocol

Separately, the FDA also provided comments on a proposed confirmatory Phase 3 study protocol submitted by the Company for hospitalized moderate to severe COVID-19 patients at risk for ARDS and death that could support a new EUA authorization and/or NDA approval. FDA stated that in the potential confirmatory Phase 3 clinical study design: "strong consideration should be given to appropriate time frames for interim analyses so that – should a strong efficacy signal again be observed – the trial could be stopped in an efficient time frame." Veru expects to communicate the details of the design and timing of this potential Phase 3 confirmatory study soon. It should be noted that in the U.S. Department of Health and Human Services’ (HHS) fact sheet published on February 9, 2023, HHS and FDA made clear that FDA’s ability to continue authorizing new COVID-19 therapeutics for emergency use is not impacted by the ending of the declaration of the U.S. public health emergency on May 11, 2023. "Our team has applied its scientific rigor and clinical expertise to expeditiously investigate sabizabulin, a microtubule disruptor, for the treatment of hospitalized critically ill COVID-19 patients during the pandemic," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "We are disappointed in the FDA’s decision to decline the request for an EUA because of the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any known influences1, and we followed the unanimous recommendation of the Independent Data Monitoring Committee to stop the Phase 3 study because of clear clinical benefit. 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. Unfortunately, COVID-19 remains a serious threat as the third leading cause of death in the U.S. with over 250,000 lives lost in 2022. We lost 510 Americans to COVID-19 just yesterday despite existing FDA authorized and approved standard of care treatments. We reaffirm our strategy to deliver sabizabulin, a potentially life-saving treatment, to this vulnerable patient population facing inadequate therapeutic options to address the threat of ARDS and death from COVID-19. To that end, we 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."