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 the clinical
results from the Phase 2 clinical study of enobosarm, an oral
selective androgen receptor targeting agonist, in heavily
pretreated women with AR+ER+HER2- advanced breast cancer including
further efficacy data and an analysis of patients who have failed
both estrogen blocking agents and CDK 4/6 inhibitors, will be
presented at the European Society for Medical Oncology (ESMO)
Breast Cancer Virtual Congress 2021 to be held May 05-08, 2021.
Highlights of presentation:The subset analysis
of patients from the Phase 2 study who were heavily pretreated with
estrogen blocking agents and chemotherapy with an average of 3
prior lines of therapy in the metastatic setting and had tumor
progression on a CDK 4/6 inhibitor prior to receiving
enobosarm.
Enobosarm treatment in evaluable patients with
measurable metastatic AR+ER+ breast cancer who had progressed
following treatment with an estrogen blocking agent and CDK 4/6
inhibitor (palbociclib) resulted in a clinical benefit rate at 24
weeks of 50% and a best objective tumor response of 30% including 2
complete responses and 1 partial response. The overall mean
radiographic progression free survival for the 9mg dose was 10
months. The 9mg dose of enobosarm was selected for the Phase 3
ARTEST study that is anticipated to commence in June 2021.
“Despite progressing on the standard of care,
patients treated with enobosarm had significant clinical
responses”, said Professor Carlo Palmieri, BSc, MB BS, PhD, FRCP,
Professor of Translational Oncology & Medical Oncologist,
University of Liverpool and the presenter of the results at the
Congress. “Targeting the androgen receptor, a tumor suppressor in
breast cancer, provides us with a potential novel endocrine therapy
with an excellent safety profile.”
“Currently, CDK 4/6 inhibitors are standard
treatment for metastatic ER-positive breast cancer, and
unfortunately, these patients will eventually develop tumor
progression. Patients who have metastatic breast cancers that
progress on estrogen receptor blocking agent and CDK4/6 inhibitor
therapies are a group in which we need to define the most optimal
drug treatment. Although a small cohort in this Phase 2 study, the
ability of these refractory patients to have significant clinical
responses to enobosarm, an AR targeted treatment, is clinically
meaningful and promising,” said Dr. Mitchell Steiner, Chairman,
President and CEO of Veru Inc. “Further, enobosarm was very well
tolerated and has shown to improve the quality of life as well. We
are excited about the Phase 3 registration clinical trial ARTEST
evaluating patients in this clinical setting.”
About EnobosarmEnobosarm is an
oral, first-in-class, new chemical entity, selective androgen
receptor targeting agonist that activates the androgen receptor,
tumor suppressor, in AR+ER+HER2- metastatic breast cancer.
Enobosarm is in clinical development for the treatment of
metastatic ER+HER2- breast cancer patients whose disease has
progressed after treatment with a nonsteroidal aromatase inhibitor
(anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor.
The Phase 3 ARTEST clinical trial is expected to begin enrollment
during the second quarter of 2021.
About Phase 2 Clinical Trial
DesignThe Phase 2 clinical study (G200802) was an
international, open label, parallel design, randomized study to
investigate the efficacy and safety of enobosarm 9mg and 18mg oral
daily dosing in 136 heavily pretreated women with ER+HER2-
metastatic breast cancer who had breast cancer progression being
treated with multiple lines of endocrine therapy including CDK 4/6
inhibitors and 90% who had also failed chemotherapy. Patients were
randomized to receive enobosarm 9mg (n=72) or 18mg (n=64) oral
daily dosing. The primary endpoint was clinical benefit rate at 24
weeks (defined as CR+PR+SD) by RECIST 1.1. Secondary endpoints
included objective response rate, best overall response rate,
radiographic progression-free survival (rPFS), and duration of
clinical benefit.
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 also disrupts androgen receptor transport, is
expected to commence in Q2 2021 with 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 in Q2 2021 and the Phase 3 clinical study is planned
to initiate in Q4 2021 to treat hormone sensitive advanced 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 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. Sabizabulin is also being
evaluated for the treatment of taxane resistant metastatic triple
negative breast cancer in a planned Phase 2b clinical study in
approximately 200 subjects expected to begin Q3 2021. 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 whether future
clinical development and results will demonstrate sufficient
efficacy and safety and potential benefits to secure FDA approval
of the Company's drug candidates, the anticipated design and scope
for clinical trials and FDA acceptance of such design and scope,
whether sabizabulin, enobosarm, VERU-100 and TADFIN will serve any
unmet need, what dosage, if any, might be approved for use in the
US or elsewhere, and whether the enrollment timelines for the
clinical trials will be met, and also statements about the
potential, timing and efficacy of the rest of the Company’s
development pipeline, including the ability of the Company to
successfully launch TADFIN. 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 take
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.
Contact:Sam Fisch800-972-0538Director of
Investor Relations
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