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 the presentation of the
Phase 1b/2 clinical trial update of sabizabulin (VERU-111), an oral
cytoskeleton disruptor which in prostate cancer also disrupts
androgen receptor transport, to treat men with metastatic
castration resistant prostate cancer who failed at least one
androgen receptor targeting agent, at the American Society of
Clinical Oncology (ASCO) 2021 Annual Meeting being held June 4-8,
2021.
The Phase 1b/2 clinical study was designed as a dynamic study
with an initial 3+3 standard safety study component followed by an
expanded study with increases in dose and schedule. The Phase 1b/2
clinical trial enrolled 80 men and is ongoing with patients in both
the Phase 1b and 2 components still on study.
Highlights of the study presentation are as follows:
- Sabizabulin oral daily dosing was well tolerated, and the most
common adverse events, being mostly Grade 1 and 2, were diarrhea,
fatigue, nausea, and decrease in appetite. There was no evidence of
clinically relevant neutropenia or neurotoxicity. Safety profile
was similar to that reported in package inserts for androgen
receptor targeting agents, abiraterone and enzalutamide.
- Clinically meaningful and durable evidence of objective tumor
responses were observed in patients on 63mg oral daily dosing
schedule:
- In the ITT population with measurable disease (n=29), the ORR
(5 partial responses + 1 complete response) was 20.7%.
- In the Phase 1b study, ITT population of men that received at
least 1 dose of 63mg daily dosing schedule (n=14), the median
progression free survival was 10.8 months (2.3-26+ months). Two of
these patients on continuous daily dosing of sabizabulin have now
reached 27 months and 23 months of treatment without prostate
cancer progression.
- In the Phase 1b/2 study of men that received at least 1 dose of
63mg daily dosing schedule (n=55), the study is still ongoing, the
median progression free survival has not been reached as 10 men
were still on study at the time of data cut off. The estimated
radiographic progression free survival is greater than 7.4
months.
“Our clinical experience with sabizabulin has demonstrated an
excellent safety profile along with significant antitumor
activity,” said Dr. Mark C. Markowski, M.D., Ph.D., Assistant
Professor of Oncology at the Johns Hopkins Sidney Kimmel
Comprehensive Cancer Center the Principal Investigator of this
Phase 1b/2 study. “A daily oral agent for men that have had disease
progression on an androgen receptor targeting agent but prior to
their advancing onto an intravenous chemotherapy would be a major
clinical advance.”
“Based on these exciting clinical results, we have reached
agreement with FDA on the design of the Phase 3 VERACITY
registration trial to evaluate the efficacy and safety of
sabizabulin in men with metastatic castration resistant prostate
cancer who have failed at least one androgen receptor targeting
agent which is expected to initiate in June 2021,” said Dr.
Mitchell Steiner, Chairman, President and CEO of Veru Inc. “Given
that sabizabulin’s safety profile appears similar to what is
reported in the package inserts for abiraterone and enzalutamide,
sabizabulin oral daily dosing may potentially be prescribed by both
urologists and medical oncologists to men with metastatic
castration and androgen targeting agent resistant prostate cancer
prior to IV chemotherapy. This is a large and growing unmet medical
need indication for the treatment of refractory prostate
cancer.”
Sabizabulin (VERU-111) Clinical Development
ProgramSabizabulin is a novel, oral, new chemical entity
that targets microtubules in the cytoskeleton to disrupt androgen
receptor transport into the nucleus. Sabizabulin is in clinical
development for: (1) Phase 3 VERACITY study for the treatment of
men with metastatic castration resistant prostate cancer who have
failed at least one androgen receptor targeting agent but prior to
receiving chemotherapy. The open-label, randomized (2:1),
multicenter Phase 3 study is expected to begin enrollment this
month to evaluate sabizabulin 32mg versus the alternative androgen
receptor targeting agent. Based on the recently conducted PK study
from the Phase 2 clinical trial, the blood levels of the Phase 3
clinical trial sabizabulin 32mg drug dose formulation were similar
to the Phase 1b/2 63mg dosage formulation. The Phase 3 VERACITY
clinical trial is expected to enroll approximately 245 patients.
(2) Phase 2 clinical study for the treatment of women with
metastatic triple negative breast cancer who have become resistant
to at least two systemic chemotherapies. The Phase 2b clinical
study will evaluate daily oral dosing of sabizabulin monotherapy,
TRODELVY® monotherapy, and sabizabulin + TRODELVY® combination
therapy in approximately 156 women. The Phase 2b clinical study is
expected to commence in the third quarter of calendar 2021. (3)
Phase 3 clinical trial for the treatment of hospitalized patients
with moderate to severe COVID-19 who are at high risk for ARDS.
Sabizabulin 9mg is being evaluated as a monotherapy versus placebo.
The Phase 3 clinical study is actively enrolling patients.
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. 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 expected to commence in June.
VERU-100, a novel, proprietary gonadotropin releasing hormone
antagonist peptide long acting 3-month subcutaneous injection
formulation for androgen deprivation therapy, is expected to start
the planned Phase 2 clinical study later this month, and the Phase
3 clinical study is planned to initiate in calendar 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
the androgen receptor, a tumor suppressor, to treat AR+ER+HER2-
metastatic breast cancer without unwanted masculinizing side effect
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
receptor 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 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 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 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 trial in approximately 300 subjects for the
treatment of hospitalized patients with moderate to severe 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
commercial 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. 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 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 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.
Contact:Sam
Fisch 800-972-0538Director
of Investor Relations
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