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

--VERU-111 significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome in COVID-19 in a toxic shock model--

 --VERU-111’s ability to disrupt microtubules has potential for dual drug action against COVID-19: treat SARS-CoV-2 virus infection and reduce Inflammation caused by viral infection-induced Cytokine Storm—

-- Phase 2 clinical study in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome actively enrolling patients --
             

MIAMI, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that it has confirmed in an in vitro study that VERU-111 has anti-inflammatory action against the key cytokines involved in the cytokine storm triggered by the SARS-CoV-2 infection.

In critically ill patients with COVID-19, SARS-CoV-2 infection triggers an overwhelming release of immune proteins called cytokines referred to as a cytokine storm.  The cytokine storm may lead to acute respiratory distress syndrome (ARDS), acute renal failure, blood clots, multi-organ failure, shock, heart arrhythmias, and death. Key cytokines released during the storm and detected in high levels in the blood from COVID-19 patients include interleukin (IL)-1α, IL-1ß, IL-6, IL-8, and Tumor Necrosis Factor α (TNFα).

VERU-111 is an oral, first-in-class microtubule depolymerization agent that has potentially both antiviral and anti-inflammatory dual action to broadly treat the cytokine storm which is associated with high COVID-19 mortality rates.

An in vitro study was conducted by a team of researchers at the University of Tennessee Health Science Center (Ms. Rui Wang, Ms. Patricia Wheller, Dr. Arnold Postlethwaite and Dr. Wei Li) to determine if VERU-111 can suppress toxic shock levels of these key cytokines of the cytokine storm. The effects of VERU-111 on cytokine production was assessed by stimulating isolated mouse spleen cells with an endotoxin that causes shock called lipopolysaccharide (LPS). The cells were stimulated with 5 μg/ml LPS for 1 hour and then incubated overnight (approximately 21 hours) with VERU-111 to mimic the clinical situation, and cytokine levels were analyzed.