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 VERACITY clinical trial of
sabizabulin, an oral, first-in-class, new chemical entity, androgen
receptor transport disruptor (targets and inhibits microtubules to
disrupt androgen receptor transport into the nucleus), for
metastatic castration and androgen receptor targeting agent
resistant prostate cancer.
The Phase 3 VERACITY clinical trial is an open label, randomized
(2:1), multicenter registration study to evaluate the efficacy and
safety of sabizabulin 32mg oral daily dosing versus an alternative
androgen receptor targeting agent for the treatment of chemotherapy
naïve men with metastatic castration resistant prostate cancer who
have progressed on at least one androgen receptor targeting agent.
The primary endpoint is median radiographic progression free
survival and key secondary endpoints are overall response rate,
duration of objective response, overall survival, time to
chemotherapy, and pain progression. The study is expected to enroll
245 patients and will be conducted in over 45 clinical sites across
the United States.
“Unfortunately, advanced prostate cancer patients receiving
androgen receptor targeting agents in combination with standard ADT
will eventually have tumor progression. There is a significant need
for new therapies with novel mechanisms of action. Sabizabulin is a
novel, oral agent with provocative levels of activity and safety in
early studies and we are now prospectively evaluating this agent in
a Phase 3 study,” said Robert Dreicer, M.D., Deputy Director, UVA
Cancer Center, Director of Solid Tumor Oncology, Professor,
Medicine: Hematology and Oncology and lead principal investigator
for the VERACITY study.
“We are excited to begin enrolling patients in our open label
Phase 3 VERACITY clinical trial,” said Mitchell Steiner, MD,
Chairman, President and CEO of Veru Inc. “As we have previously
reported, in the Phase 1b/2 clinical trial sabizabulin had
significant evidence of tumor efficacy including PSA declines and
responses as well as objective and durable tumor responses.
Furthermore, sabizabulin was well tolerated without neutropenia. In
fact, the safety profile of sabizabulin appears to be similar to
what is reported in the package inserts for an androgen receptor
targeting agent such as enzalutamide or abiraterone. If the Phase 3
is successful, sabizabulin could be the next ‘go to drug’ in the
largest and growing unmet medical need in men who have metastatic
castration resistant prostate cancer and who have developed
progression of prostate cancer while being treated with an androgen
receptor targeting agent, but prior to using IV chemotherapy.”
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 enrolling. 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.
"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 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 VERU-100 as an androgen deprivation
therapy for advanced prostate cancer; the potential for TADFIN to
treat BPH; whether the VERACITY study or any other current or
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
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 |
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800-972-0538 |
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Phase 3 Clinical Trial
Contact:veruclinicaltrials@verupharma.com Domingo
Rodriguez MD 800-445-6348 |
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