Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company,
today announced positive efficacy and safety results from a planned
interim analysis of the double-blind, randomized,
placebo-controlled Phase 3 COVID-19 clinical trial evaluating oral
sabizabulin 9 mg versus placebo in 150 hospitalized COVID-19
patients at high risk for Acute Respiratory Distress Syndrome
(ARDS). The Independent Data Safety Monitoring Committee
unanimously recommended that the Phase 3 study be halted early due
to efficacy, and they further remarked that no safety concerns were
identified.
Phase 3 COVID-19 Trial Design
The Phase 3 COVID-19 study is a double-blind, randomized,
placebo-controlled Phase 3 clinical trial evaluating oral,
once-a-day dosing of sabizabulin 9 mg versus placebo in
approximately 210 hospitalized moderate to severe COVID-19 patients
(≥WHO 4) 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 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
primary efficacy endpoint was the proportion of patients that died
by Day 60.
Clinical Efficacy and Safety ResultsThe
prespecified primary endpoint was death at or before day 60.
Sabizabulin treatment resulted in a clinically and statistically
meaningful 55% relative reduction in deaths (p=0.0029) in the
intent to treat population. Placebo group (n=52) had a 45%
mortality rate compared to the sabizabulin-treated group (n=98)
which had a 20% mortality rate. The secondary efficacy endpoints
are still being analyzed at the time of this release.
Sabizabulin treatment was well tolerated in this patient
population with no clinically relevant safety observations in the
sabizabulin treated group compared to placebo.
Regulatory Discussions and Planning
The Company plans to meet with FDA to discuss next steps
including the submission of an emergency use authorization
application. As previously disclosed, the FDA granted Fast Track
designation to the sabizabulin COVID-19 clinical program in January
2022, which the Company hopes will help streamline the emergency
use authorization process.
The Company has scaled up manufacturing processes to produce
commercial drug supply to address anticipated drug needs following
potential FDA authorization.
The Company has been in discussions with BARDA and other US
government agencies in an effort to secure an advance purchasing
agreement of drug product for the U.S. “This study represents a
significant milestone in the global fight against COVID-19 as
sabizabulin is the first drug to demonstrate a clinically and
statistically meaningful reduction in deaths in hospitalized
patients with moderate to severe COVID-19,” said Mitchell Steiner,
M.D., Chairman, President and Chief Executive Officer of Veru. “We
strongly believe that sabizabulin, with its dual anti-viral and
anti-inflammatory properties which demonstrated positive efficacy
and safety results in the Phase 3 COVID-19 study, can be that
greatly needed oral therapy for hospitalized moderate to severe
COVID-19 patients,” Dr. Steiner continued.
“What makes these findings more relevant is that the
pharmacological activity of sabizabulin is independent of COVID-19
variant type. Pending upcoming discussion with FDA, this treatment
option may be made available soon so we can be ready for when the
next clinically important wave of COVID infections comes,” said
Gary Barnette, PhD, Chief Scientific Officer of Veru.
“We expect new COVID-19 variant infections and new challenges in
the treatment of hospitalized patients, particularly as the country
heads into the fall and winter seasonal cycle. With the results of
this Phase 3 COVID-19 study, we now have a treatment option for the
sickest hospitalized COVID patients,” 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. “We have battled this pandemic for almost two and a
half years now. A 55% reduction in deaths in hospitalized patients
is tremendously meaningful to patients, their families, doctors,
nurses, hospital staff and the communities they serve,” added Dr.
Skolnick.
Event DetailsThe Company will host a conference
call today at 8:00 am ET to discuss the positive efficacy and
safety results from the interim analysis and next steps. Interested
parties may access the call by dialing 1-800-341-1602 from the U.S.
or 1-412-902-6706 from outside the U.S. and asking to be joined
into the Veru Inc. call. The call will also be available through a
live, listen-only audio broadcast via the Internet at
www.verupharma.com. Listeners are encouraged to visit the website
at least 10 minutes prior to the start of the scheduled
presentation to register, download and install any necessary
software. A playback of the call will be archived and accessible on
the same website for at least three months. A telephonic replay of
the conference call will be available, beginning the same day at
approximately 12 p.m. (noon) ET by dialing 1-877-344-7529 for U.S.
callers, or 1-412-317-0088 from outside the U.S., passcode 5820166,
for one week.
About Veru Inc.Veru is an oncology
biopharmaceutical company with a principal focus on developing
novel medicines 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, a cytoskeleton disruptor.
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.
- Planned 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).
The Company has determined that patients who have ≥ 40% androgen
receptor nuclei staining by immunohistochemistry in their breast
cancer tissue, a measure of AR expression, are most likely to
respond to enobosarm. Consequently, Veru is developing a companion
diagnostic test to determine a patient’s androgen receptor
expression status and has partnered with Roche/Ventana Diagnostics,
a world leader in oncology companion diagnostic tests, which will
develop and, if it is approved, commercialize the AR companion
diagnostic test.
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.
In addition, sabizabulin, which has dual antiviral and
anti-inflammatory effects, has completed a Phase 3 COVID-19
clinical study for the treatment of hospitalized moderate to severe
COVID-19 patients ( WHO 4) who were at high risk for ARDS and
death. The Phase COVID-19 clinical study was stopped early for
positive efficacy following a planned interim analysis. The Company
is seeking an emergency use authorization.
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 meet with FDA or receive an emergency use authorization or any
approval from FDA for sabizabulin for certain COVID-19 patients;
whether and when sabizabulin will become an available treatment
option for certain COVID-19 patients; whether the Company will have
sufficient supply of sabizabulin to meet demand, if an emergency
use authorization or other approval is granted; whether the Company
will secure any advance purchase agreement with the U.S.
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 US 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. 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 and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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