Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
prostate and breast cancer, today announced that it has enrolled
the first patient in its Phase 3 clinical trial of sabizabulin, a
novel, proprietary, oral cytoskeleton disruptor with
anti-inflammatory and anti-viral properties, to combat the effects
of COVID-19, the global pandemic disease caused by the novel
coronavirus SARS-CoV-2.
“COVID-19 infection rates and hospitalizations are still at
serious levels. There are mutating and double mutating virus
strains, and large parts of the population either unable or
unwilling to get access to effective vaccines. In fact, global
cases of COVID-19 are at the highest levels since the start of the
pandemic. It is clear that an effective and safe oral therapeutic
that prevents deaths in hospitalized patients with moderate to
severe COVID-19 disease who are at risk for Acute Respiratory
Distress Syndrome (ARDS) is desperately needed,” said Mitchell
Steiner, MD, Chairman, President and Chief Executive Officer of
Veru Inc. “We strongly believe that sabizabulin with its
anti-inflammatory and anti-viral properties and its favorable
safety profile can be that greatly needed oral therapy. With the
aim of meeting our recruitment goals by year end, we have selected
clinical sites in locations that have been hard hit by COVID-19 in
the US, Brazil, Argentina, Colombia, and Mexico.”
Sabizabulin (VERU-111) Phase 3 Trial DesignThe
Phase 3 clinical trial is a double-blind, multicenter,
multinational, randomized (2:1), placebo-controlled trial
evaluating daily oral doses of 9mg sabizabulin for up to 21 days
versus placebo in 300 hospitalized patients (200 subjects will be
treated with sabizabulin and 100 subjects will receive
placebo/standard of care) who tested positive for the SARS-CoV-2
virus and who are at high risk for ARDS. Because of better oral
bioavailability, the systemic blood levels from the 9mg sabizabulin
dosage are similar to the 18mg sabizabulin formulation used in the
Phase 2 clinical study. Subjects in the sabizabulin and placebo
arms will also be allowed to receive standard of care. The primary
efficacy endpoint will be the proportion of patients that die on
study up to Day 60. Secondary endpoints will include the proportion
of patients without respiratory failure, days in ICU, WHO Ordinal
Scale for Clinical Improvement change from baseline, days on
mechanical ventilation, days in the hospital, and viral load. The
study will be conducted in the United States, Brazil, Argentina,
Mexico, and Colombia. Enrollment is targeted to be completed by
year-end.
About Sabizabulin (VERU-111) as a Therapeutic for
COVID-19Sabizabulin is a cytoskeleton disruptor which by
causing microtubule depolymerization has both anti-viral and
anti-inflammatory activity and could be effective against the
SARS-CoV-2 virus by disrupting its intracellular transport along
the microtubules. Microtubule trafficking is critical for viruses
to be transported, replicated, assembled, and released from the
cell. In addition, microtubule depolymerization drugs that target
the “colchicine binding site” of microtubules, like sabizabulin,
also have strong anti-inflammatory effects, including the potential
to treat the cytokine release syndrome (cytokine storm) and septic
shock induced by the SARS-CoV-2 viral infection that is associated
with high COVID-19 mortality rates.About the Phase 2
COVID-19 Clinical TrialVeru conducted a double-blind,
randomized, placebo-controlled Phase 2 clinical trial evaluating
oral, once-a-day dosing of sabizabulin versus placebo in 39
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 sabizabulin 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 hospitalized patients (a modified
intent-to-treat (MITT) population), sabizabulin treatment compared
to placebo had a 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 sabizabulin treated
group (n=18) at Day 29. This represents an 81% relative reduction
in the sabizabulin treatment failures.
For secondary endpoints: in the Intent to Treat (ITT)
population, sabizabulin reduced the proportion of patients who died
on study from 30% (6/20) in the placebo group to 5.3% (1/19) in the
sabizabulin treated group (p=0.044). This is an 82% relative
reduction in mortality in the sabizabulin treated group. In a MITT
population, sabizabulin showed a statistically significant and
clinically meaningful reduction in days in ICU (sabizabulin
patients at 3.00 ± 7.37 days versus placebo 9.55 ± 12.56; p=0.04).
Sabizabulin reduced the days on mechanical ventilation from an
average of 5.4 days in the placebo group to 1.6 days in the
sabizabulin treated group. Sabizabulin was tolerated with a good
safety profile.
Sabizabulin (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 eleven patients in the entire study that did not receive
standard of care of either remdesivir or dexamethasone (six in the
sabizabulin treated group and five in the placebo group). In
patients that did not receive the standard of care, sabizabulin
treatment resulted in a statistically significant reduction in days
in ICU (sabizabulin 0 days versus placebo 9.53 ± 12.56 days;
p=0.014) and days on mechanical ventilation (sabizabulin zero days
versus placebo 3.93 ± 8.74 days). In the sabizabulin group on
standard of care, no patient required ICU admission or 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.
Veru’s prostate cancer pipeline includes: sabizabulin, an oral,
first-in-class, new chemical entity that targets the cytoskeleton
disruptor which in prostate cancer also disrupts androgen receptor
transport, is expected to commence this month a Phase 3 VERACITY
clinical trial in approximately 245 men for the treatment of
metastatic castration and androgen receptor targeting agent
resistant prostate cancer. VERU-100, a novel, proprietary GnRH
antagonist peptide long acting 3-month subcutaneous injection
formulation for androgen deprivation therapy, is expected to start
the planned Phase 2 clinical study this month and the Phase 3
clinical study is planned to initiate in Q4 2021 to treat hormone
sensitive metastatic prostate cancer. Veru’s breast cancer pipeline
includes: enobosarm, an oral, first-in-class, new chemical entity,
selective androgen receptor agonist that targets and activates the
androgen receptor, a tumor suppressor, to treat AR+ER+HER2-
metastatic breast cancer without unwanted masculinizing side
effects; Phase 3 ARTEST clinical trial to evaluate enobosarm in a
3rd line metastatic setting in approximately 210 subjects with
AR+ER+HER2- advanced breast cancer who have failed nonsteroidal
aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor is
anticipated to commence Q2 2021. In a separate clinical development
program, a Phase 2 study to evaluate the efficacy and safety of
enobosarm in combination with CDK 4/6 inhibitor (abemaciclib)
compared to estrogen receptor blocking agent (Active Control) for
the treatment of AR+ER+HER2- metastatic breast cancer in a 2nd line
metastatic setting in approximately 106 patients who have failed an
estrogen receptor blocking agent plus a CDK 4/6 inhibitor
(palbociclib) is expected to commence in calendar Q3 2021.
Sabizabulin is also being evaluated in a three arm Phase 2b
clinical study in calendar Q3 2021 to evaluate oral daily dosing of
sabizabulin monotherapy, TRODELVY® monotherapy, and sabizabulin +
TRODELVY combination therapy in approximately 200 women with
metastatic triple negative breast cancer that have become resistant
to at least 2 systemic chemotherapies including a taxane. Based on
positive Phase 2 results on the reduction of mortality, sabizabulin
is also being evaluated in a Phase 3 trial in approximately 300
subjects 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® (internal condom) (“FC2”), an FDA-approved
product for 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. The second potential product,
if approved, expected for the Sexual Health Business is 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). An NDA was filed by
FDA in April 2021 with a PDUFA date in December 2021. To learn more
about Veru products, please visit www.verupharma.com.
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 the potential of sabizabulin
to combat COVID-19 and prevent deaths in patients with moderate to
severe COVID-19 disease who are at risk for ARDS, whether future
clinical development and results will demonstrate sufficient
efficacy and safety to secure FDA approval of the Company's drug
candidate, whether sabizabulin will serve any unmet need, what
dosage of sabizabulin, if any, might be approved for use in the US
or elsewhere, and whether the enrollment timelines will be met, and
also statements about the potential, timing and efficacy of the
rest of the Company’s development pipeline.
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
trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials 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 trials, 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; 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, 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. The Company disclaims any intent
or obligation to update these forward-looking statements.
Investor Contact: Sam
Fisch 800-972-0538Phase
3 Clinical Trial Contact:veruclinicaltrials@verupharma.com
Domingo Rodriguez MD 800-606-9382
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