Veru says terminating Phase 3 VERACITY trial of sabizabulin

In a regulatory filing, Veru stated that on March 14, at the Oppenheimer 33rd Annual Healthcare Conference, Dr. Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of the company, presented Veru’s updated strategy as part of the company’s ongoing effort to refocus its drug development efforts on those drug candidates which it believes have the best opportunity to lead to long-term success and shareholder value creation and conserve cash, including a reduction in personnel and certain other measures to reduce costs. "The presentation included a description of Veru’s refocused research and development strategy which includes the following: (i) plans for continued development of sabizabulin in Phase 3 COVID-19 confirmatory study in hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory disease syndrome, or ‘ARDS,’ and planned development of sabizabulin in Phase 3 clinical study in hospitalized influenza patients at high risk for ARDS, (ii) plans for an updated ongoing Phase 3 study of enobosarm and abemaciclib combination in the second line setting for AR+ ER+ HER2- metastatic breast cancer patients, into which Veru plans to roll the current ARTEST study, if agreed by the U.S. Food and Drug Administration and the company’s clinical trial partner, Eli Lilly & Company (LLY), and (iii) a planned Phase 3 study of enobosarm in bone-only non-measurable metastatic ER+ HER2- breast cancer. In addition, Dr. Steiner announced that Veru is reserving sabizabulin for clinical development only in infectious disease indications, and accordingly, terminating the Phase 3 VERACITY trial of sabizabulin in certain prostate cancer patients. Further, Phase 2 development of the Veru-100 and zuclomiphene assets will be paused. On March 2, 2023, Veru had announced that the FDA declined to grant at this time Veru’s request for Emergency Use Authorization for sabizabulin to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for ARDS," the filing stated.