Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company,
today announced that the FDA agreed in an End of Phase 2 meeting,
to advance VERU-111 into a Phase 3 registration clinical study
based on the clinically meaningful benefits observed with VERU-111
treatment in the recently completed double-blind, randomized,
placebo-controlled Phase 2 clinical trial evaluating oral,
once-a-day dosing of VERU-111 versus placebo in approximately 40
hospitalized COVID-19 patients at high risk for ARDS. The Phase 2
trial demonstrated clinically meaningful reductions in relevant
endpoints, including respiratory failure, patient mortality, days
in the ICU and days on mechanical ventilation. VERU-111 has the
potential for two-pronged action against COVID-19 as an antiviral
and an anti-inflammatory agent which is supported by positive Phase
2 clinical study results.
“We are very pleased with the outcome of the FDA meeting. FDA
was extremely collaborative and thought that the clinical data from
the Phase 2 were promising and suggest a potential clinically
meaningful benefit for the use of VERU-111 in hospitalized high
risk COVID-19 patients. Also, the FDA agreed that VERU-111 warrants
further development in a Phase 3 program,” said Mitchell Steiner,
M.D., Chairman, President and Chief Executive Officer of Veru. “Due
to the urgency of the global pandemic and need for more effective
treatment options for patients, we remain duty-bound to pursue this
indication, even though it has not been the primary focus of Veru.
We have the resources to conduct a Phase 3 trial without impacting
our cancer drugs’ clinical development.”
We have met with and will seek funding from The Biomedical
Advanced Research and Development Authority of the US Department of
Health and Human Services (BARDA) as well as other agencies to fund
the estimated amount of commercial drug to supply the needs of the
US population, assuming confirmatory positive Phase 3 clinical
results and FDA approval.
Phase 3 Clinical Trial Design:
With a similar trial design to the completed positive Phase 2
study, the Phase 3 clinical registration trial design will evaluate
daily oral doses of VERU-111 versus placebo with the primary
efficacy endpoint of proportion of patients alive at Day 29. It is
expected that the Phase 3 clinical trial will be conducted in
approximately 400 hospitalized patients who have SARS-CoV-2 virus
infection and are at high risk for ARDS at a 2:1 ratio between the
VERU-111 (approximately 267 patients) and placebo (approximately
133 patients) treated groups.
The Company has enough clinical drug supply on hand to complete
the Phase 3 clinical study. The Phase 3 clinical trial is expected
to commence in April 2021 and clinical results are expected by the
fourth quarter of calendar year 2021.
About the Phase 2 COVID-19 Clinical Trial:
Veru conducted a double-blind, randomized, placebo-controlled
Phase 2 clinical trial evaluating oral, once-a-day dosing of
VERU-111 18mg versus placebo in approximately 40 hospitalized
COVID-19 patients who were at high risk for ARDS. The trial was
conducted in five sites across the United States. Patients
hospitalized with documented evidence of COVID-19 infection and at
high risk for ARDS were enrolled. Subjects received an 18mg dose of
VERU-111 or placebo, as well as standard of care for 21 days or
until released from hospital. The primary efficacy endpoint was the
proportion of patients alive without respiratory failure at Day
29.
Clinical Efficacy and Safety Results:
For the primary endpoint in a modified intent-to-treat (MITT)
population, VERU-111 treatment compared to placebo had a
statistically significant and clinically meaningful reduction in
the proportion of patients who are treatment failures (dead or
alive with respiratory failure) with a 30% treatment failure rate
in the placebo group (n=20) compared to 5.6% in the VERU-111
treated group (n=18) at Day 29. This represents an 81% relative
reduction in the VERU-111 treatment failures and showed statistical
significance with p=0.05.
For secondary endpoints: in the Intent to Treat (ITT)
population, VERU-111 reduced the proportion of patients who died on
study from 30% (6/20) in the placebo group to 5.3% (1/19) in the
VERU-111 treated group (p=0.044). This is an 82% relative reduction
in mortality in the VERU-111 treated group. In an MITT population,
VERU-111 showed a statistically significant and clinically
meaningful reduction in days in ICU (VERU-111 patients at 3.00 ±
7.16 days versus placebo 9.55 ± 11.54; p=0.04). VERU-111 reduced
the days on mechanical ventilation from an average of 5.4 days in
the placebo group to 1.6 days in the VERU-111 treated group.
VERU-111 was tolerated with a good safety profile.
VERU-111 and Standard of Care
During the study, the standard of care included treatment with
remdesivir and/or dexamethasone under an Emergency Use
Authorization. The use of remdesivir and dexamethasone did not have
a significant effect on patient outcomes in the study. A subgroup
analysis of patients that received standard of care was conducted.
There were six patients in the entire study that did not receive
standard of care of either remdesivir or dexamethasone (four in the
VERU-111 treated group and two in the placebo group). In patients
that did not receive the standard of care, VERU-111 treatment
resulted in a statistically significant reduction in days in ICU
(VERU-111 1.43 ± 3.96 days versus placebo 8.83 ± 13.07 days;
p=0.024) and days on mechanical ventilation (VERU-111 zero days
versus placebo 6.00 ± 10.57 days; p=0.0427). In the VERU-111 group
on standard of care, no patient required mechanical ventilation on
study.
About Veru Inc.Veru Inc. is an oncology
biopharmaceutical company with a focus on developing novel
medicines for the management of prostate cancer and breast cancer.
The Veru prostate cancer pipeline includes VERU-111, VERU-100, and
Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new
chemical entity that targets, crosslinks, and disrupts alpha and
beta tubulin subunits of microtubules for the treatment of
metastatic castration and androgen receptor resistant prostate
cancer. VERU-100 is a novel, proprietary peptide formulation
designed to address the current limitations of commercially
available androgen deprivation therapies (ADT) for advanced
prostate cancer. Zuclomiphene citrate is an oral nonsteroidal
estrogen receptor agonist being developed to treat hot flashes, a
common side effect caused by ADT in men with advanced prostate
cancer. The Veru breast cancer pipeline includes enobosarm for
AR+/ER+/HER2- metastatic breast cancer and VERU-111 for taxane
resistant metastatic triple negative breast cancer. Enobosarm is an
oral, first-in-class, new chemical entity, selective androgen
receptor agonist that targets and activates the androgen receptor
in AR+/ER+/HER2- metastatic breast cancer without unwanted
masculinizing side effects. VERU-111 is also being advanced into
Phase 3 for the treatment of hospitalized patients with COVID-19
who are at high risk for acute respiratory distress syndrome.
The Company’s Sexual Health Business commercial product is the
FC2 Female Condom®/ FC2 Internal Condom (“FC2”), an FDA-approved
product for the dual protection against unintended pregnancy and
the transmission of sexually transmitted infections. The Company’s
Female Health Company Division markets and sells FC2 commercially
and in the public health sector both in the U.S. and globally. In
the U.S., FC2 is available by prescription through multiple
third-party telemedicine and internet pharmacy providers and retail
pharmacies. In the global public health sector, the Company markets
FC2 to entities, including ministries of health, government health
agencies, U.N. agencies, nonprofit organizations and commercial
partners, that work to support and improve the lives, health and
well-being of women around the world. An NDA was submitted in
February 2021 for TADFIN™ (tadalafil 5mg and finasteride 5mg)
capsule for the administration of tadalafil 5mg and finasteride 5mg
combination formulation dosed daily for benign prostatic
hyperplasia (BPH). Tadalafil (CIALIS®) is currently approved for
treatment of BPH and erectile dysfunction and finasteride is
currently approved for treatment of BPH (finasteride 5mg PROSCAR®)
and male pattern hair loss (finasteride 1mg PROPECIA®). If
approved, revenues from TADFIN™ (tadalafil 5mg and finasteride 5mg)
capsule and the current revenues from the FC2 business will be
combined in our sexual health commercial business. To learn more
about Veru products, please visit www.verupharma.com.
"Safe Harbor" statement under the Private Securities
Litigation Reform Act of 1995: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 expected timing of studies
for the treatment of COVID-19 using VERU-111, the therapeutic
potential for VERU-111 to treat COVID-19,whether funding from BARDA
or other agencies will be forthcoming, the regulatory pathway to
secure FDA approval of the Company's drug candidates, the
anticipated design and scope of the clinical trial, the anticipated
timeframe for clinical studies and FDA submissions, clinical study
results including potential benefits and the absence of adverse
events, and our resources to conduct clinical trials. Any
forward-looking statements in this release are based upon the
Company's current plans and strategies and reflect the Company's
current assessment of the risks and uncertainties related to its
business and are made as of the date of this release. The Company
assumes no obligation to update any forward-looking statements
contained in this release because of new information or future
events, developments or circumstances. Such forward-looking
statements are subject to known and unknown risks, uncertainties
and assumptions. If any such risks or uncertainties materialize or
if any of the assumptions prove incorrect, our actual results could
differ materially from those expressed or implied by such
statements. Factors that may cause actual results to differ
materially from those contemplated by such forward-looking
statements include, but are not limited to, the following: risks
related to the development of the Company's product portfolio,
including clinical trials, regulatory approvals and time and cost
to bring to market; potential delays in the timing of and results
from clinical trials and studies, including potential delays in the
recruitment of patients and their ability to effectively
participate in such trials and studies due to COVID-19, and the
risk that such results will not support marketing approval and
commercialization; potential delays in the timing of any submission
to the FDA and regulatory approval of products under development
and the risk that disruptions at the FDA caused by the COVID-19
pandemic may delay the review of submissions or approvals for new
drugs; the risk of a delay or failure in reaching agreement with
the FDA on the design of a clinical trial or in obtaining
authorization to commence a clinical trial; clinical results or
early data from clinical trials may not be replicated or continue
to occur in additional trials or may not otherwise support further
development in the specified product candidate or at all; our
pursuit of a COVID-19 treatment candidate is at an early stage and
we may be unable to develop a drug that successfully treats the
virus in a timely manner, if at all; risks related to our
commitment of financial resources and personnel to the development
of a COVID-19 treatment which may cause delays in or otherwise
negatively impact our other development programs, despite
uncertainties about the longevity and extent of COVID-19 as a
global health concern and the possibility that as vaccines become
widely distributed the need for new COVID-19 treatment candidates
may be reduced or eliminated; government entities may take actions
that directly or indirectly have the effect of limiting
opportunities for VERU-111 as a COVID-19 treatment, including
favoring other treatment alternatives or imposing price controls on
COVID-19 treatments; the risk that the Company's products may not
be commercially successful; risks related to the impact of the
COVID-19 pandemic on our business, the nature and extent of which
is highly uncertain and unpredictable; risks relating to the
ability of the Company to obtain sufficient financing on acceptable
terms when needed to fund development and operations, including our
ability to secure timely grant or other funding to develop VERU-111
as a potential COVID-19 treatment; product demand and market
acceptance; competition in the Company's markets and therapeutic
areas and the risk of new or existing competitors with greater
resources and capabilities and new competitive product approvals
and/or introductions; the risk that the Company will be affected by
regulatory developments, including a reclassification of products;
price erosion, both from competing products and increased
government pricing pressures; manufacturing and quality control
problems; compliance and regulatory matters, including costs and
delays resulting from extensive governmental regulation, and
effects of healthcare insurance and regulation, including
reductions in reimbursement and coverage or reclassification of
products; some of the Company's products are in development and the
Company may fail to successfully commercialize such products; risks
related to intellectual property, including the uncertainty of
obtaining patents, the effectiveness of the patents or other
intellectual property protections and ability to enforce them
against third parties, the uncertainty regarding patent coverages,
the possibility of infringing a third party’s patents or other
intellectual property rights, and licensing risks; government
contracting risks, including the appropriations process and funding
priorities, potential bureaucratic delays in awarding contracts,
process errors, politics or other pressures, and the risk that
government tenders and contracts may be subject to cancellation,
delay, restructuring or substantial delayed payments; the risk 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; a
governmental tender award indicates acceptance of the bidder's
price rather than an order or guarantee of the purchase of any
minimum number of units, and as a result government ministries or
other public sector customers may order and purchase fewer units
than the full maximum tender amount or award; penalties and/or
debarment for failure to satisfy tender awards; 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; risks related to
concentration of accounts receivable with our largest customers and
the collection of those receivables; the economic and business
environment and the impact of government pressures; risks involved
in doing business on an international level, including currency
risks, regulatory requirements, political risks, export
restrictions and other trade barriers; 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; risks related
to the 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 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, 2020 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.
|
|
Investor Contact: |
Sam Fisch |
800-972-0538 |
|
Phase 3 Clinical Trial
Contact: |
veruclinicaltrials@verupharma.com |
Domingo Rodriguez MD 800-445-6348 |
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