Veru Reaches Agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication: Hospitalized Adult Patients with Any Type of Viral Acute Respiratory Distress Syndrome (ARDS)
--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 “tripledemic viruses”: Influenza, RSV, and SARS-CoV-2--
-- Based on high mortality rate for viral ARDS, expected sabizabulin Phase 3 study size is 408 patients with all-cause mortality at Day 60 as the primary endpoint--
--The Company plans to conduct the “all comers” viral ARDS Phase 3 study instead of the second confirmatory Phase 3 COVID-19 study--
-- Enrollment could begin as early as calendar Q4 2023--
MIAMI, FL, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for viral induced ARDS, today announced that in a September 21, 2023 meeting, the Company and FDA reached agreement on the design of a new Phase 3 clinical trial study to evaluate sabizabulin plus standard of care treatment in an expanded patient population, hospitalized adult patients who have broadly any type of virus causing ARDS. The Phase 3 study may suffice as a single study for NDA submission.
Highlights from the September 21st FDA meeting
FDA agreed to a Phase 3, randomized (1:1), multicenter, placebo-controlled, parallel group design study to evaluate the efficacy and safety of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in hospitalized adult patients with any type of virus inducing ARDS:
- Novel indication (patient population) for sabizabulin has been expanded to include all hospitalized adult patients with any type of viral induced ARDS
- Primary efficacy endpoint is all-cause mortality at day 60
- Secondary endpoints include days in the hospital, days in the ICU, days on mechanical ventilation, and proportion of patients alive without respiratory failure
- Given the high mortality rate for viral induced ARDS (27-45%), the expected size of the study is 408 patients
- If Phase 3 study were to demonstrate sufficient benefit on all-cause mortality at Day 60, then this study could potentially be sufficient for NDA submission
- As the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin
"As sabizabulin has broad host directed antiviral and anti-inflammatory activities and an already completed, positive well controlled and adequate Phase 3 COVID-19 clinical study in patients at risk for or had ARDS, we felt compelled to reengage with FDA to consider the possibility of expanding the patient population to include hospitalized adult patients that have any type of viral induced ARDS, especially in light of the CDC expecting a high rate of tripledemic virus hospitalizations this fall and winter,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We are pleased with the outcome of our meeting with FDA in which they agreed to a Phase 3 study design that allows the treatment of sabizabulin to be evaluated on top of standard of care in a broader hospitalized viral induced ARDS patient population. FDA agrees that ARDS is a well-defined disease with a high mortality rate in which there is a compelling unmet medical need.”
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for metastatic breast cancer and for viral ARDS.
Oncology program: metastatic breast cancer
The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist.
- Phase 3 clinical ENABLAR-2 study – enobosarm +/- abemaciclib combination versus estrogen blocking agent (active control) as a 2nd line treatment in AR+ ER+ HER2- metastatic breast cancer is open and active. The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly supplies Verzenio® (abemaciclib).
Infectious disease program: viral ARDS
- COVID-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. In April 2023, the Company reached agreement with FDA on design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. Although the Company reached agreement with FDA for the design of Phase 3 confirmatory COVID-19 clinical trial, the Company met with FDA in September and reached agreement on the design of Phase 3 study design evaluating sabizabulin 9mg for the broader treatment of hospitalized adult patients who have any type of viral ARDS.
- Smallpox virus: The Company had a pre-IND meeting in August with FDA to discuss the development of sabizabulin for smallpox virus. FDA agreed that the Animal Rule pathway is acceptable for evaluating the efficacy of smallpox virus. The Company will work with FDA to develop a plan for the nonclinical studies that could support a smallpox indication.
Sexual health program – Urev
Veru has a commercial sexual health division called Urev that is comprised of 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. The Company has launched its own independent, FC2-dedicated direct to patient telehealth and pharmacy services portal. The Company is focused on executing new contracts with additional telehealth partners and has internet fulfillment pharmacy partners that provide coverage in all 50 states in the U.S.
The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: the planned design, enrollment, timing, commencement, interim and full data readout timing, scope, regulatory pathways, and results of the Company’s current and planned clinical trials, including the planned Phase 3 study of sabizabulin in hospitalized adult patients with viral induced ARDS, the Phase 3 study of enobosarm alone or in combination with abemaciclib for the 2nd line treatment of AR+ ER+ HER2 metastatic breast cancer, the Phase 3 study of enobosarm in bone-only non-measurable hormone receptor and HER2- metastatic breast cancer, the Phase 3 study of sabizabulin in hospitalized influenza patients at high risk of ARDS, and studies of sabizabulin in smallpox virus and Ebola virus, and whether any of such studies will meet any of its primary or secondary endpoint; whether the results of the planned sabizabulin ARDS study will be sufficient to support the submission of an NDA and the timing of any such data reading out; whether the Company will pursue any Phase 3 study of sabizabulin for COVID-19 alone; whether and when the Company will receive the future installment payments of the ENTADFI purchase price or sales milestone payments; and the outlook for growth in the Company's FC2 business through telehealth customers, our direct to patient telehealth portal and the global public health sector. These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the possibility that as vaccines, antivirals and other treatments become widely distributed the need for new COVID-19 or other ARDS treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 or other ARDS treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 or other ARDS treatments; the Company’s existing products, including FC2 and, if authorized, sabizabulin, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telemedicine and telepharmacy services platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company’s ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s and third party manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the fiscal year ended September 30, 2022 and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. The Company disclaims any intent or obligation to update these forward-looking statements.
Executive Director, Investor Relations and Corporate Communications