Veru Inc., an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, announced that it has enrolled the first patient in its Phase 2 clinical trial of VERU-111, a novel microtubule depolymerization drug to combat COVID-19, the global pandemic disease caused by the coronavirus SARS-CoV-2.
“It’s clear that new and more effective drugs are still needed to fight the COVID-19 pandemic. We are excited to lead the effort to evaluate a novel drug like VERU-111. VERU-111 has the potential for both antiviral and anti-inflammatory treatment of patients infected with SARS-CoV-2 who are at high risk for Acute Respiratory Distress Syndrome,” said Michael S. Gordon, MD, Medical Director, HonorHeatlh Research Institute in Scottsdale, Arizona. HonorHealth is the first hospital in the State of Arizona to offer this treatment and patients may participate in the trial at HonorHealth Scottsdale Osborn Medical Center, HonorHealth Scottsdale Shea Medical Center or HonorHealth John C. Lincoln Medical Center.
“We are excited to report that we have started our Phase 2 clinical trial evaluating the safety and efficacy of VERU-111 in treating COVID-19, the disease caused by the novel coronavirus SARS-CoV-2,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Uniquely, VERU-111 has the dual potential to both inhibit the SARS-CoV-2 virus as confirmed by recent viral testing in Vero cells in a biocontainment laboratory, as well as treat the severe inflammation caused by the SARS-CoV-2 viral infection which leads to Acute Respiratory Distress Syndrome. We expect with the recent surge in COVID-19 new infections that we should quickly enroll this Phase 2 study,” added Dr. Steiner.
VERU-111 COVID-19 Trial Design
The Phase 2 clinical trial is a double-blind randomized (1:1) placebo-controlled trial evaluating daily oral doses of 18 mg VERU-111 or placebo over 21 days in 40 hospitalized patients (20 subjects will be treated with VERU-111 and 20 subjects will receive placebo) who tested positive for the SARS-CoV-2 virus and who are at high risk for Acute Respiratory Distress Syndrome. The primary efficacy endpoint will be proportion of subjects that are alive without respiratory distress at Day 29. Secondary endpoints will include measures of 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. This study is designed to evaluate VERU-111’s ability to improve pulmonary symptoms and recovery and to avoid the need for mechanical ventilation. Eligibility criteria can be found on the ClinicalTrials.gov website.
About VERU-111 as a Therapeutic for COVID-19
VERU-111, a microtubule depolymerization drug with antiviral activity, could be effective against the SARS CoV-2 virus by disrupting its intracellular transport along the microtubules. Microtubule trafficking is critical for viruses to cause infection. Furthermore, microtubule depolymerization drugs that target alpha and beta tubulin subunits of microtubules, like VERU-111, also have strong anti-inflammatory effects, including the potential to treat the cytokine release syndrome (cytokine storm) and septic shock induced by the SARS-CoV-2 viral infection that seems to be associated with high COVID-19 mortality rates.
About Veru Inc.
Veru Inc. is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. The Veru prostate cancer pipeline includes VERU-111, Zuclomiphene citrate and VERU-100. VERU-111 is an oral, next-generation, first-in-class small molecule that targets and disrupts alpha and beta tubulin subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). VERU-100 is anticipated to enter a Phase 2 dose-finding study with a potential start date in the third quarter of calendar year 2020.
Call to Action: Those interested can learn more about the trial here. The trial has multiple site locations, such as those in Arizona, Minnesota, Nevada, and New Jersey.