GnRHR x ER x AR

MIAMI, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the Phase 3 COVID-19 study results of Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) were presented at the 11th International Conference on Emerging Infectious Diseases (ICEID) on August 8, 2022. Presentation Highlights Sabizabulin is an oral, novel microtubule disruptor that has dual antiviral and anti-inflammatory activity. In a double-blind, multicenter, and placebo-controlled Phase 3 clinical study evaluating sabizabulin 9 mg versus placebo (randomized 2:1) in 204 hospitalized moderate-severe COVID-19 patients (requiring oxygen) who were at high risk for ARDS and death (NCT04842747). At a planned interim analysis in the first 150 patients randomized, the study was halted by the Independent Data Monitoring Committee for clear demonstration of efficacy. For the primary endpoint which was all cause mortality by Day 60, a clinically meaningful and statistically significant 55.2% relative reduction in deaths was observed in the intent-to-treat population (p=0.0041). Sabizabulin treatment also resulted in a 43% relative reduction in days in ICU (p=0.0013), 49% relative reduction in days on mechanical ventilation (p=0.0013), and 26% relative reduction in days in hospital (p=0.0277) vs placebo. The proportion of patients with an adverse event or a serious adverse event was lower in the sabizabulin compared to the placebo group. August 08, 2022: 4:15 PM – 4:30 PM Eastern Time Oral Sabizabulin Reduces Mortality in Hospitalized COVID-19 Patients with at High Risk for ARDS Oral Presentation Number: E4.5 Presenter: Michael Gordon MD, Chief Medical Officer at HonorHealth Research and Innovation Institute in Scottsdale, Arizona Additional information on the meeting can be found on the ICEID website: https://www.iceid.org/ “The results of this Phase 3 trial confirm the earlier Phase 2 data affirming the value of sabizabulin in hospitalized patients with moderate to severe COVID 19 infection. It is exciting to have another option to address this difficult to treat population,” said Michael Gordon MD, Chief Medical Officer, Honor Health Research and Innovation Institute, one of the lead investigators. “We are very excited about the consistent and clinically meaningful reductions in morbidity and mortality in hospitalized COVID-19 patients at high risk for ARDS demonstrated in both the Phase 2 and 3 studies. We continue to admit COVID-19 patients to our hospitals, and we need more effective medications there to reduce complications and mortalities,” said Michael Schnaus, MD, Medical Director of the Critical Care Research Center at the Health Partners’ Institute in St. Paul, MN, which participated in the Phase 2 and Phase 3 clinical trials. “The large reduction in deaths in this high-risk population was confirmed in the Phase 3 COVID-19 study. We are currently engaged with the FDA, EMA, MHRA, and regulatory agencies in other countries to seek emergency authorization and/or expedited reviews. If authorized, we have scaled up manufacturing to meet the demands of this summer’s COVID-19 surge as well as the seasonal surges that are expected in fall and winter,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. About Veru Inc. Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers. Infectious disease program: The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (≥ WHO 4-supplemental oxygen) at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and no safety concerns. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. On June 7, 2022, the Company submitted a request for emergency use authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence®. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) informed the Company on July 25, 2022, that the sabizabulin marketing authorization application will receive expedited review. On July 26, 2022, The European Medicines Agency’s Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries. Oncology program: The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin. Current studies on the two drugs include: Enrolling Phase 3 ARTEST study of enobosarm in androgen receptor positive, estrogen receptor positive, and human epidermal growth factor receptor two negative (AR+ ER+ HER2-) metastatic breast cancer with AR ≥ 40% expression (third-line metastatic setting), and which has been granted Fast Track designation by the FDA. Enrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer with AR ≥ 40% expression (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib). Planned Phase 2b study of sabizabulin in AR+ ER+ HER2- metastatic breast cancer with AR Veru’s late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist. Current studies on these drugs include: Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy. Enrolling Phase 2 dose-finding study of VERU-100 in advanced hormone sensitive prostate cancer. Planned Phase 2b study of zuclomiphene citrate to treat hot flashes in men with advanced prostate cancer undergoing androgen deprivation therapy. Commercial sexual health program, Urev, has 2 FDA approved products: ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway. FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally.