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 the publication of the results from a
Phase 3 COVID-19 study evaluating the efficacy and safety of oral
sabizabulin, a novel dual antiviral and anti-inflammatory agent,
for the treatment of hospitalized moderate-severe COVID-19 patients
at high risk for acute respiratory distress syndrome (ARDS) and
death in The New England Journal of Medicine (NEJM) Evidence.
The Phase 3 COVID-19 clinical trial is a
double-blind, randomized, multicenter, and global
placebo-controlled study evaluating oral, once-a-day dosing of
sabizabulin 9 mg versus placebo in approximately 210 hospitalized
moderate to severe COVID-19 patients (≥ WHO 4, supplemental
oxygen) who were at high risk for ARDS and death. Patients were
randomized in a 2:1 ratio to the sabizabulin treatment group versus
placebo. Patients in both treatment groups were allowed to receive
standard of care treatment including remdesivir, dexamethasone,
anti-IL6 receptor antibodies, and JAK inhibitors. The trial was
conducted in the United States, Brazil, Colombia, Argentina,
Mexico, and Bulgaria. COVID-19 infections treated in the study
included the Delta and Omicron variants. A planned interim analysis
was conducted in the first 150 patients randomized into the study.
The Independent Data Safety Monitoring Committee unanimously
recommended that the Phase 3 study be halted early due to clear
efficacy benefit. For the primary efficacy endpoint, which was
death at or before day 60, sabizabulin treatment resulted in a
clinically and statistically meaningful 55.2% relative reduction in
deaths (p=0.0042) in the intent to treat population (ITT). At Day
60, the placebo group (n=52) had a 45.1% mortality rate compared to
the sabizabulin-treated group (n=98) which had a 20.2% mortality
rate. In the overall study of 204 randomized patients, the
reduction in the all-cause mortality (ITT population) was similar
to the results observed in the interim efficacy analysis patient
population with sabizabulin treatment resulting in a 51.6%
reduction in deaths compared to the placebo group.
The key secondary endpoints included effects of
sabizabulin treatment on mortality through Day 29, with a placebo
mortality rate of 35.3% compared to sabizabulin treatment mortality
rate of 17%, sabizabulin treatment resulted in an absolute
reduction of 18.3 percentage points and a relative reduction in
deaths of 51.8%. 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) compared to
placebo group. Adverse and serious adverse events were lower in the
sabizabulin group compared to the placebo group.
“We are proud and honored to have the Phase 3
COVID-19 study results published in The New England Journal of
Medicine Evidence, a highly prestigious peer reviewed medical
journal. The overall conclusion of this Phase 3 study is that
sabizabulin treatment has a clear mortality benefit compared to
placebo in hospitalized COVID-19 patients at high risk for ARDS
receiving standard of care treatment with no significant safety
signals,” said Gary Barnette, PhD, Chief Scientific Officer of Veru
and co-author of the NEJM Evidence publication.
“Unfortunately, COVID-19 is here to stay with new
variants emerging and with rising rates of new cases,
hospitalizations, and deaths. The current death rate from COVID-19
infection is unacceptable,” said Alan Skolnick, M.D., Principal
Investigator with HD Research, who conducted this Phase 3 COVID-19
study at Memorial Hermann Memorial City Medical Center in Houston
TX, co-author of the NEJM Evidence publication.
“We have battled this pandemic for two and a half
years now, and we are still in desperate need for an effective
treatment like sabizabulin to significantly reduce deaths in
hospitalized COVID-19 patients. It’s in the hospital that we have
the last real opportunity to prevent deaths from COVID-19
infection,” added Dr. Skolnick.
“This landmark study published in The New England
Journal of Medicine Evidence shows the high consistency of
sabizabulin treatment to significantly reduce deaths across patient
subgroups regardless of standard of care treatment received,
baseline WHO scores, age, comorbidities, vaccination status,
COVID-19 variant, or geography,” said Mitchell Steiner, M.D.,
Chairman, President, and Chief Executive Officer of Veru and
co-author of the NEJM Evidence publication. “We have submitted a
request for emergency use authorization with FDA and are in
discussions with other regulatory authorities across the
world.”
Regulatory Discussion and
Planning
The Company submitted a request for an EUA
application on June 7, 2022.
The Company has scaled up manufacturing and expects
to be able to produce sufficient commercial drug supply to address
anticipated drug needs following potential FDA authorization in the
U.S. and subsequent authorizations in other countries and
regions.
The Company is having discussions with government
agencies to discuss purchases and reimbursement for sabizabulin in
the U.S. and other countries around the world.
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.
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 < 40% expression (third-line
metastatic setting).
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.
Veru also has a commercial sexual health division –
Urev, the proceeds of which help fund its drug development
programs, comprised of 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.
Forward-Looking StatementsThe
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: whether
and when the Company will receive an emergency use authorization or
any approval from FDA or from any regulatory authority outside the
U.S. for sabizabulin for certain COVID-19 patients; whether and
when sabizabulin will become an available treatment option for
certain COVID-19 patients in the U.S. or anywhere outside the U.S.;
whether the Company will have sufficient supply of sabizabulin to
meet demand, if an emergency use authorization or other approval is
granted in the U.S. or in any other country; whether the Company
will secure any advance purchase agreement with the U.S. government
or any foreign government; whether the current and future clinical
development and results will demonstrate sufficient efficacy and
safety and potential benefits to secure FDA approval of the
Company’s drug candidates and companion diagnostic; whether the
drug candidates will be approved for the targeted line of therapy;
the anticipated design and scope of clinical studies and FDA
acceptance of such design and scope; whether any regulatory
pathways, including the accelerated Fast Track designations, to
seek FDA approval for sabizabulin, enobosarm or any of the
Company’s drug candidates are or continue to be available; whether
the expected commencement and timing of the Company’s clinical
studies, including the Phase 3 ENABLAR-2 study, the sabizabulin
monotherapy Phase 2b clinical study for 3rd line treatment of
metastatic breast cancer, the Phase 2 registration clinical study
for VERU-100, and the development of the companion diagnostic will
be met; when clinical results from the ongoing clinical studies
will be available, whether sabizabulin, enobosarm, VERU-100,
zuclomiphene, and ENTADFI will serve any unmet need or, what
dosage, if any, might be approved for use in the U.S. or elsewhere,
and also statements about the potential, timing and efficacy of the
rest of the Company’s development pipeline, and the timing of the
Company’s submissions to FDA and FDA’s review of all such
submissions; whether any of the selective clinical properties
previously observed in clinical studies of sabizabulin, enobosarm,
VERU-100 or other drug candidates will be replicated in the current
and planned clinical development program for such drug candidates
and whether any such properties will be recognized by the FDA in
any potential approvals and labeling; whether the companion
diagnostic for enobosarm will be developed successfully or be
approved by the FDA for use; and whether and when ENTADFI will be
commercialized successfully. 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; the timing of any submission to the FDA and
any determinations made by the FDA or any other regulatory
authority; the possibility that as vaccines become widely
distributed the need for new COVID-19 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 treatment, including
favoring other treatment alternatives or imposing price controls on
COVID-19 treatments; the Company’s existing products and any future
products, if approved, possibly not being commercially successful;
the effects of the COVID-19 pandemic and measures to address the
pandemic on the Company’s clinical studies, supply chain and other
third-party providers, commercial efforts, and business development
operations; 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; the Company’s ability to successfully
commercialize any of its products, if approved; 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, and development costs; 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, COVID-19 (including the
impact of COVID-19 on suppliers of key raw materials), product
testing, transportation delays or regulatory actions; costs and
other effects of litigation, including product liability claims;
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, 2021
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.
Verzenio® is a registered trademark of Eli Lilly
and Company
Investor Contact: Veruinvestor@verupharma.com Samuel Fisch -
Executive Director, Investor Relations and Corporate
Communications
Media Contact: Anthony.berry@canalecomm.com Anthony Berry -
Evoke Canale
Medical Contact: Medical@verupharma.com Tara Gonzales - Vice
President, Medical Affairs Infectious Diseases Franchise
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