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

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.

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-111 is being evaluated in men with metastatic castration and androgen-blocking agent resistant prostate cancer in two portions of an ongoing open label clinical trial – the Phase 1b portion and the Phase 2 portion.  The Phase 2 portion targets men who have metastatic castration-resistant prostate cancer who have also become resistant to novel androgen blocking agents, such as abiraterone or enzalutamide, but prior to proceeding to IV chemotherapy -- also referred to as the prechemotherapy stage.  VERU-111 will also be evaluated in a Phase 2 clinical trial to assess the efficacy of VERU-111 in combating COVID-19.  Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being evaluated for estrogenic activity in a Phase 2 trial (Stage 1 testing placebo, Zuclomiphene 10mg, and Zuclomiphene 50mg) to treat hot flashes, a common side effect caused by androgen deprivation therapy (ADT) in men with advanced prostate cancer.  Following an End of Phase 2 meeting with the FDA, the Company plans to advance Zuclomiphene Citrate to a Phase 3 clinical trial in men with advanced prostate cancer who experience moderate to severe hot flashes with a potential start date in late calendar year 2020.  VERU-100 is a novel, proprietary peptide formulation for ADT with multiple potential beneficial clinical attributes addressing the shortfalls of current FDA-approved ADT formulations for the treatment of advanced prostate cancer.  VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist designed to be administered as a small volume subcutaneous 3-month depot injection without a loading dose.  VERU-100 will immediately suppress testosterone with no testosterone surge upon initial or repeated administration --- a problem that occurs with currently approved luteinizing hormone-releasing hormone (LHRH) agonists used for ADT. There are no GnRH antagonists commercially approved beyond a one-month injection.  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.