--Reached agreement with FDA on single Phase 3 clinical trial design to expand treatment population to include all hospitalized adult patients with any type of virus induced ARDS including the...
Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60 Study to expand treatment population to include all...
Veru Announces Preclinical Study Results that Demonstrate Sabizabulin Inhibits Poxviruses
In the final report, sabizabulin significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome (ARDS) in H1N1 influenza pulmonary inflammation murine ARDS modelnnPositive Phase 3 COVID-19 clinical study and preclinical influenza study further support the potential use of sabizabulin as a broad antiviral and anti-inflammatory agent for viral-induced ARDSnnExpedited meeting granted by U.S. FDA in April 2023 for Phase 3 confirmatory study in hospitalized COVID-19 patients at high risk for ARDSnVeru plans Phase 3 clinical study in hospitalized influenza patients at high risk for ARDSnMIAMI, FL, April 04, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), Veru Inc., a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced results from a preclinical study of sabizabulin demonstrating robust anti-inflammatory activity with improved outcomes in an Influenza-Induced Pulmonary Inflammation Mouse Acute Respiratory Distress Syndrome (ARDS) Model.nnPreclinical study background:nnAn animal study was conducted by a team of researchers at Labcorp Early Development Laboratories, Ltd, United Kingdom. The purpose of the study was to evaluate the efficacy of sabizabulin in the influenza H1N1 pulmonary inflammation mouse ARDS model. Two hours before starting treatment, mice were administered H1N1 or saline via the intranasal route to induce a viral infection and inflammatory response in the lung followed by daily treatments with saline, sabizabulin, dexamethasone (anti-inflammatory control), or oseltamivir (direct antiviral control).nnClinical signs and longitudinal lung function (Penh) were measured, bronchioalveolar lavage (BAL), which is washings from lungs, was collected to determine both amounts of inflammatory cells and levels of cytokines, and histopathologic examination of lungs was performed to evaluate inflammation.nnPreclinical study results highlights:nnSabizabulin treatment resulted in a statistically significant decrease in the total number of inflammatory cells (-53%) (p<0.01) in BAL fluid, including statistically significant reductions in both the innate and adaptive immune cells. In addition, sabizabulin treatment showed a statistically significant reduction in key cytokines and chemokines in BAL fluid that are part of the cytokine storm responsible for the acute lung injury: Keratinocyte-derived chemokine (KC) (-38%;p<0.01), Interleukin-6 (IL-6) (-74%;p<0.001), TNF-? (-36%;p<0.05), Interferon-? ( INF-?) (-84%;p<0.001), and CXCL-10 (-60%;p<0.001). In contrast, dexamethasone treatment did not demonstrate a statistically significant reduction in the total number of inflammatory cells in the BAL fluid. Dexamethasone also had a different effect from sabizabulin on cytokine production in the BAL fluid. Dexamethasone treatment resulted in statistically significant reductions for IL-6 (-52 %;p<0.01) and INF-? (-81 %;p<0.001), but no statistically significant changes for KC (+20%), TNF-? (-13%), and CXCL- 10 (-8%).nnClinically, sabizabulin treatment resulted in a reduction in the severity of lung inflammation (by histopathology) and a dose-dependent improvement of lung function (lower Penh vs untreated H1N1 infection). Oral administration of 2 mg/kg sabizabulin resulted in the reduction of the clinical signs and body weight loss associated with H1N1 infection. From Day 11, four out of seven animals displayed no clinical signs associated with the induction of H1N1 infection. Whereas, oral administration of 1 mg/kg dexamethasone did not result in reduction of the clinical signs or body weight loss associated with H1N1 infection.nnThe Company expects to submit the full data set for presentation in future scientific meetings and peer-reviewed publications.nnSabizabulin’s anti-inflammatory effects were previously reported in a preclinical septic shock mouse model with suppression of key cytokines responsible for severe acute respiratory distress syndrome (ARDS). This mouse model predicted the clinical benefit of sabizabulin demonstrated in a positive randomized, multicenter placebo-controlled Phase 3 clinical trial in hospitalized moderate to severe COVID-19 patients who were at high risk for ARDS and death. Sabizabulin treatment plus standard of care resulted in a 51.6% relative reduction in deaths compared to placebo plus standard of care (odds ratio, 2.77; 95% CI confidence interval, 1.37 to 5.60; p=0.0046).nnThese data suggest that sabizabulin has the potential to be an effective treatment for hospitalized influenza patients at high risk for ARDS and death. Pathogenesis and mortality rates for patients with hospitalized influenza ARDS are similar to COVID-19-associated ARDS, representing a high unmet need with very limited treatment options. According to CDC, the influenza burden estimates in the United States were up to 630,000 hospitalizations and up to 55,000 deaths in the past 6 months. Accordingly, Veru is planning a double-blind randomized placebo-controlled Phase 3 clinical trial evaluating sabizabulin in hospitalized adult influenza patients at high risk for ARDS.nn“Viral-induced acute respiratory distress syndrome is a leading cause of death in patients with COVID-19 and influenza and remains an unmet medical need worldwide,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “Sabizabulin, as a host targeted antiviral and broad spectrum anti-inflammatory agent, has the potential to address the two most common causes of viral-induced ARDS: COVID-19 and influenza. Based on the preclinical data highlighted today, we plan to initiate a Phase 3 study of sabizabulin in influenza patients at high risk for ARDS, as well as expand the sabizabulin program into other serious virus infections that result in ARDS and potentially death. Furthermore, we look forward to providing an update on the upcoming FDA meeting we will be having this month to finalize the clinical trial design for the Phase 3 confirmatory COVID-19 study and to confirm the requirements for an EUA submission and new drug application.”nnAbout Veru Inc.nVeru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the treatment of breast cancer.nnInfectious disease programnnCOVID-19: Sabizabulin is an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and host mediated antiviral properties. Veru has conducted a positive double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. The Company is planning to conduct a Phase 3 confirmatory clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. Veru has been granted a meeting with U.S. FDA in April 2023 to finalize clinical trial design and requirements for an EUA submission and new drug application.nInfluenza: The Company is planning a Phase 3 clinical trial to evaluate sabizabulin in hospitalized influenza patients at high risk for ARDS.nOncology programnThe Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist.nnEnrolling Phase 3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer (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).nPlanned Phase 3 study of enobosarm in nonmeasurable bone only metastatic breast cancer.nSexual health program - UrevnVeru also has a commercial sexual health division - Urev - comprised of 2 FDA approved products:nnENTADFI® (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia, for which commercialization launch plans are underway.nFC2 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.
March 14 (Reuters) - Drug developer Veru Inc (VERU.O) on Tuesday said it plans to proceed with a late-stage trial of its COVID-19 pill, weeks after the U.S. health regulator declined to authorize the oral drug to treat high-risk patients hospitalized with COVID-19.
Following the advice of a panel of outside experts, the FDA has turned down a potential Covid-19 drug that only had data from a small trial.
MIAMI, FL, March 02, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).
Nov 9 (Reuters) - A panel of outside advisers to the U.S. health regulator on Wednesday voted against authorizing Veru Inc's (VERU.O) drug for treating high-risk patients hospitalized with COVID-19, citing multiple concerns over efficacy and safety data being based on a small trial.
While acknowledging that Veru’s potential drug for Covid-19 hospitalizations hit the mark on mortality in a small trial, and may have enough for an EUA with a confirmatory trial add-on, the FDA also pointed to uncertainties in the data ahead of an adcomm meeting Wednesday.
MIAMI, Oct. 13, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that data from the Phase 3 trial of sabizabulin for hospitalized moderate to severe COVID-19 patients who required supplemental oxygen has been accepted as a late-breaker oral presentation at the upcoming IDWeek (Infectious Disease Week) 2022 taking place October 19-23, 2022, in Washington, D.C.