VERU-111 Suppresses Key Cytokines Responsible for Severe Acute Respiratory Distress Syndrome in COVID-19 - Seite 2

At a concentration that represents the blood levels of VERU-111 observed in clinically dosed patients, VERU-111 (40 nM) significantly reduced the production of key cytokines known to be involved with COVID-19 cytokine storm: TNFα (-31%) (p=0.006), IL-1α (-123%) (p=0.0005), IL-1β(-97%) (p=0.0003), IL-6 (-85%) (p<0.00008), and IL-8 homologue (-96%) (p<0.0000007). This reduction was similar to, or greater than, depending on the specific cytokine, to that observed with dexamethasone (10nM), a steroid and a known inhibitor of cytokine production during inflammation.  

Suppression of these key cytokines may be an effective way to prevent clinical deterioration of patients with COVID-19 to ARDS. Veru is currently enrolling a double-blind randomized (1:1) placebo-controlled Phase 2 clinical trial evaluating daily oral doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients who tested positive for the SARS-CoV-2 virus and are at high risk for ARDS.  The primary efficacy endpoint will be the proportion of patients that are alive and without respiratory failure at Day 22. 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.

“Although Veru is focused on prostate cancer and oncology, due to the urgency of the current global pandemic and the need for effective drugs against COVID-19, 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 having antiviral activity, and now confirmed in this in vitro study that VERU-111 also has the ability to suppress key cytokines in COVID-19 patients, we are even more hopeful that VERU-111 should show in the Phase 2 study with COVID-19 patients at high risk for ARDS, an improvement in patient outcomes.”

Dr. Steiner added, “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 nearing completion of enrollment into our Phase 2 prostate cancer clinical trial. This current cytokine study also further supports the use of VERU-111 in prostate cancer as cytokines IL-6, IL-1, and IL-8 appear to play key roles in the promotion of prostate cancer progression, metastases, and drug resistance. The ability of VERU-111 to suppress these cytokines may benefit men who have metastatic castration resistant prostate cancer which is the primary indication that VERU-111 is being developed for.”