Veru Announces the Presentation of a Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castr...
June 28 2021 - 8:30AM
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
prostate and breast cancers, today announced updated clinical
results from the ongoing Phase 1b/2 clinical study of sabizabulin
(VERU-111), an oral cytoskeleton disruptor being evaluated for the
treatment of metastatic castration resistant prostate cancer in men
who progressed on an androgen receptor targeting agent, were
accepted for presentation at the European Association of Urology
36th Annual Congress. The Congress is being held virtually from
July 8-12, 2021.
Poster Discussion SessionAbstract
# P0859: Sabizabulin (VERU-111), an
oral cytoskeleton disruptor, to treat men with metastatic
castration resistant prostate cancer who progressed on an androgen
receptor targeting agent.Presenter: Dr. Robert H.
Getzenberg, Veru – Executive Vice President for Medical
AffairsPoster Discussion Session: #29 – Metastatic
Prostate CancerDate/Time: Sunday, July 11, 2021
4-5 PM CEST
Additional information on the meeting can be found on the EAU
website https://eaucongress.uroweb.org/
“The data from our Phase 1b/2 trial show that oral, daily
sabizabulin is well tolerated and based upon its efficacy has the
potential to fill the largest and growing unmet clinical 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,” said Dr. Mitchell S. Steiner, Chairman,
President and CEO of Veru Inc. “We are excited to be initiating the
Phase 3 VERACITY trial in this patient population.”
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 to treat hormone sensitive advanced
prostate cancer, is currently enrolling in a Phase 2 trial, and the
Phase 3 clinical trial is planned to initiate in calendar Q4 2021.
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 initially 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 of sabizabulin
to treat metastatic castration and androgen receptor targeting
agent resistant prostate cancer and the share and size of the
market to treat the unmet medical need , 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 VERU-100 as an androgen
deprivation therapy for advanced prostate cancer; the potential for
enobosarm to treat AR+ER+HER2- metastatic breast cancer and without
the unwanted masculinizing side effects; 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, including trials related to Covid-19 due to increased
vaccination rates in the U.S., 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 and the inability to enroll patients in the
trials for the treatment of Covid-19; 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.
Contact:Sam Fisch Director of Investor
Relations800-972-0538
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