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 2 clinical trial of VERU-100, a
novel, proprietary gonadotropin-releasing hormone (GnRH) antagonist
decapeptide, three-month subcutaneous depot injection formulation,
for the treatment of hormone sensitive advanced prostate cancer.
Androgen deprivation therapy, also known as ADT, is currently
the mainstay of advanced prostate cancer treatment and is used as a
foundation of treatment throughout the course of the disease.
Furthermore, ADT is continued even as other endocrine,
chemotherapy, or radiation treatments are added or stopped. The ADT
market is well-established for advanced prostate cancer and is
estimated to be approximately $2.8 billion worldwide. Standard
medical practice for urologists and medical oncologists is to
administer ADT every 3-4 months which coincides with follow-up
office medical visits and ensures maximum compliance with ADT for
patients with advanced prostate cancer.
Androgen deprivation therapy using a GnRH antagonist is
preferred because castration occurs rapidly within a week with no
surges or flares in testosterone levels. Testosterone also tends to
reach lower levels which may improve tumor control. GnRH antagonist
ADT also lowers FSH levels which is thought to be the reason why,
in published studies, there are fewer cardiovascular side effects
with GnRH antagonists versus GnRH agonists (LUPRON and ELIGARD).
Unfortunately, there are no GnRH antagonist depot injection
formulations for ADT approved by FDA for treatment beyond a
one-month duration. VERU-100 is a novel, proprietary long-acting
peptide, 3-month subcutaneous depot formulation injection that does
not require a loading dose designed to address these current
limitations of commercially available androgen deprivation
therapies.
VERU-100 Phase 2 Trial Design
The Phase 2 clinical trial is an open label, multicenter, dose
finding study evaluating the efficacy and safety of subcutaneous
injected doses of VERU-100 in 35 men with hormone sensitive
advanced prostate cancer. The primary efficacy endpoint is percent
of men that reach castrate levels of total testosterone (<50
ng/dL) by Day 28 and maintain castrate testosterone levels beyond
90 days. The secondary endpoint is the percent of men that reach
<20 ng/dL of total testosterone levels by Day 28 that are
maintained at <20 ng/dL through Day 91.
“I am excited about the clinical development of
VERU-100. While GnRH antagonists are the preferred approach, a
long-acting injectable alternative does not exist. VERU-100 would
fill an unmet clinical need and provide an opportunity for the
urologist to maintain the continuity of care with our patients and
maximize drug compliance for their cancer treatment,” said Ronald
Tutrone, MD, FACS, CPI, Chair, William H. Kalhert Endowment for
Urological Research and Medical Director, Chesapeake Urology
Research Associates.
“If successful and approved, VERU-100 could address an unmet
medical need by providing a long-acting GnRH antagonist formulation
as a low volume injection treatment option with immediate
castration, drug compliance, and potentially less concerns for
cardiovascular safety events without disrupting current standard of
medical care. We expect the Phase 2 clinical results to be
available in the second half of this calendar year. Further, we
have already reached FDA agreement on the Phase 3 registration
trial design. It will be an open label multicenter study to
evaluate the efficacy and safety of VERU-100 in approximately 100
men with hormone sensitive advanced prostate cancer and is
anticipated to start towards the end of calendar year 2021,” said
Mitchell Steiner, MD, Chairman, President and Chief Executive
Officer of Veru Inc.
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 the transport of
the androgen receptor. A Phase 3 VERACITY clinical trial evaluating
the efficacy and safety of sabizabulin in approximately 245 men for
the treatment of metastatic castration and androgen receptor
targeting agent resistant prostate cancer is anticipated to start
in early calendar Q3 2021. VERU-100, a novel, proprietary
gonadotropin releasing hormone antagonist peptide long acting
3-month subcutaneous injection formulation for androgen deprivation
therapy, is currently enrolling, and the Phase 3 clinical study is
planned to initiate in calendar 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 the androgen receptor, a
tumor suppressor, to treat AR+ER+HER2- metastatic breast cancer
without unwanted masculinizing side effects. The enobosarm clinical
program is initially focusing on 2 indications: 1) Phase 3 ARTEST
clinical trial to evaluate enobosarm monotherapy in a 3rd line
metastatic setting in approximately 210 subjects with AR+ER+HER2-
metastatic breast cancer (≥ 40% AR positivity) who have failed
nonsteroidal aromatase inhibitor, fulvestrant, and a CDK 4/6
inhibitor which is anticipated to commence calendar Q3 2021; 2)
Phase 2 study to evaluate the efficacy and safety of enobosarm and
CDK 4/6 inhibitor, abemaciclib, combination compared to estrogen
blocking agent (Active Control) for the treatment of AR+ER+HER2-
metastatic breast cancer (≥ 40% AR positivity) in a 2nd line
metastatic setting in approximately 106 patients who have failed
1st line treatment in a metastatic setting with CDK 4/6
inhibitor, palbociclib, in combination with either an aromatase
inhibitor or fulvestrant which is expected to commence in calendar
Q3 2021. Sabizabulin will also be evaluated in a three arm Phase 2b
clinical study planned to initiate in calendar Q3 2021 to evaluate
oral daily dosing of sabizabulin monotherapy, TRODELVY®
monotherapy, and sabizabulin + TRODELVY combination therapy in
approximately 156 women with metastatic triple negative breast
cancer that have become resistant to at least two 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 clinical trial for the treatment of
hospitalized patients with moderate to severe COVID-19 who are at
high risk for acute respiratory distress syndrome in approximately
300 subjects and is currently enrolling.
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 commercial product, if approved, expected for
the Sexual Health Business is TADFIN™ (tadalafil 5mg and
finasteride 5mg) capsule dosed daily for benign prostatic
hyperplasia (BPH). An NDA was filed by FDA in April
2021 with a PDUFA date in December 2021. The Company
plans to launch through telemedicine and telepharmacy sales
channels. 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 for VERU-100 as
an androgen deprivation therapy for advanced prostate cancer; what
share of the worldwide ADT market in advanced prostate cancer
VERU-100, if successful and approved, might achieve; whether
VERU-100 will fill an unmet need in prostate cancer treatment or
will be safe; when the Phase 2 data will be available and when the
planned Phase 3 study for VERU-100 will commence; the potential of
sabizabulin to treat metastatic castration and androgen receptor
targeting agent resistant prostate cancer, taxane resistant
metastatic triple negative breast cancer and COVID-19 and prevent
deaths in patients with moderate to severe COVID-19 disease who are
at risk for ARDS; the potential for enobosarm to treat AR+ER+HER2-
metastatic breast cancer; the potential for TADFIN to treat BPH;
whether the VERU-100 studies, the VERACITY study or any other
current or future clinical development and results will demonstrate
sufficient efficacy and safety and potential benefits to warrant
further development or secure FDA approval of the Company’s drug
candidates; the anticipated design and scope of the Company’s
clinical trials and FDA acceptance of such design and scope;
whether sabizabulin, enobosarm, VERU-100 or TADFIN will serve any
unmet need and the potential size of any patient population; what
dosage, if any, might be approved for use in the US or elsewhere;
whether the enrollment timelines for the Company’s clinical trials
will be met; and also statements about the potential, timing and
efficacy of the rest of the Company’s development pipeline,
including whether and when TADFIN might be approved by the FDA and
the ability of the Company to successfully launch TADFIN, if
approved.
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
800-972-0538Clinical Trial
Contact:veruclinicaltrials@verupharma.com Domingo
Rodriguez MD 800-606-9382
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