Veru Secures FDA Agreement to Initiate Phase 2 Study of VERU-111, Novel Drug to Combat COVID-19

Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, announced that it has received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111, a microtubule depolymerization agent, in combating COVID-19, the global pandemic disease caused by the novel coronavirus SARS-CoV-2.

VERU-111 is an oral, first-in-class microtubule depolymerization agent that targets the colchicine binding site of a and b tubulin subunits to inhibit microtubules and is currently under clinical development in prostate cancer.  Drugs that target microtubules have broad antiviral activity by disrupting the intracellular transport of viruses such as SARS CoV-2, along microtubules. Microtubule trafficking is critical for viruses to cause infection. Furthermore, microtubule depolymerization agents that target a and b tubulin subunits of microtubules also have strong anti-inflammatory effects including the potential to treat the cytokine release syndrome (cytokine storm) induced by the SARS-CoV-2 viral infection that seems to be associated with high COVID-19 mortality rates.

The Company met with FDA and received agreement on the clinical development program for VERU-111 as a potential dual antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program–Coronavirus Treatment Acceleration Program (CTAP).

The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients (VERU-111 20 subjects and placebo 20 subjects) who tested positive for the SARS-CoV-2 virus and are at high risk for Acute Respiratory Distress Syndrome (ARDS).  The primary efficacy endpoint will be the proportion of patients that are alive and without respiratory failure at Day 29.  Secondary endpoints include the measured improvements on the WHO Disease Severity Scale (8-point ordinal scale) which captures COVID-19 disease symptoms and signs including hospitalization to progression of pulmonary symptoms to mechanical ventilation as well as death. The study is expected to commence in the next 2 weeks.

VERU-111 has been shown to be well tolerated in the Phase 1b clinical study of 39 men as recently reported. VERU-111 is currently being administered as a 63mg daily dose in the ongoing Phase 2 clinical trial in men with metastatic castration resistant prostate cancer. The Phase 2 COVID-19 study will evaluate an 18mg oral daily dosing single treatment for 21 days.

“VERU-111 has demonstrated promising anticancer activity and a good safety profile in the recently completed Phase 1b metastatic castration resistant prostate cancer trial. We are now actively enrolling men into our Phase 2 prostate cancer clinical trial.  Although Veru is focused in prostate cancer and oncology, due to the urgency of the current global pandemic and the fact that VERU-111 has the potential to treat both SARS-CoV-2 infection and the associated reactive severe lung inflammation in COVID-19 patients at high risk for ARDS, the Company is duty-bound to pursue this COVID-19 indication even though it is not the primary focus of the Company,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Based on the strong pharmacologic rationale as well as the preclinical and clinical studies supporting that VERU-111 may have both antiviral and anti-inflammatory effects along with acceptable safety against the SARS-CoV-2 virus, we will initiate this placebo controlled Phase 2 study in patients that have been hospitalized for SARS-CoV-2 at high risk for ARDS to improve symptoms and recovery and to avoid the need for mechanical ventilation. We plan to dose the first patient in the next 2 weeks,” said Dr. Steiner.

Because of the urgent need for effective and timely therapeutics to combat COVID-19, the Company has applied for significant grant funding through both The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) and The Defense Advanced Research Projects Agency of the US Department of Defense (DARPA) to expedite the clinical development program of VERU-111 for COVID-19. There is no guarantee that such grant funding will be provided.

Source: Veru, Inc.