| Veru Enrolls First Patient in Phase 2 Clinical Trial of Novel Drug, VERU-111, to Combat COVID-19 --VERU-111 has potential to treat both the SARS-CoV-2 virus infection and the severe inflammation leading to acute respiratory distress syndrome-- MIAMI, June 19, 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, 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-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 is also being 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 should immediately suppress testosterone with no testosterone surge upon initial or repeated administration --- a problem which 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. Veru is also advancing new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology such as the Tadalafil and Finasteride Combination (TADFIN(R) ) for the administration of tadalafil 5mg and finasteride 5mg combination formulation dosed daily for benign prostatic hyperplasia (BPH). Tadalafil (CIALIS(R) ) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5mg PROSCAR(R)) and male pattern hair loss (finasteride 1mg PROPECIA(R) ). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than by finasteride alone. The Company had a successful pre-NDA meeting with the FDA and the expected submission of the NDA for TADFIN is the fourth quarter of calendar year 2020 or early 2021. Veru is also developing Tamsulosin XR capsules which is a formulation of tamsulosin, the active ingredient in FLOMAX(R) , which Veru has designed to avoid the "food effect" inherent in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance. The Company's commercial products include the FC2 Female Condom / FC2 Internal Condom(R) ("FC2"), an FDA-approved product for the dual protection against unwanted pregnancy and the transmission of sexually transmitted infections, and the PREBOOST(R) 4% benzocaine medicated individual wipe for the treatment of premature ejaculation. The Company's Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the U.S. and globally. In the U.S., FC2 is available by prescription through multiple third party telemedicine and internet pharmacy providers, retail pharmacies, as well as OTC via the Company's website at www.fc2.us.com. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, U.N. agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. PREBOOST(R) is marketed exclusively through online sales in the U.S. under the Roman Swipes brand name by Roman Health Ventures Inc. Roman is a leading telemedicine company that discreetly sells men's health products via the internet website www.getroman.com. To learn more about Veru products please visit www.verupharma.com. About HonorHealth: HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses five acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation and community services with approximately 12,300 employees, 3,700 affiliated physicians and 3,100 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth's mission is to improve the health and well-being of those we serve. Learn more at HonorHealth.com. |
