Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company
with a focus on developing novel medicines for the management of
breast and prostate cancer, today announced that updated clinical
data from the positive Phase 1b/2 study of sabizabulin in 80 men
with metastatic castration resistant prostate cancer who have
progressed on at least one novel androgen receptor targeting agent
will be presented at the 2022 ASCO Genitourinary Cancers Symposium
being held February 17-19, 2022 in San Francisco, CA. Sabizabulin
is an oral new chemical entity that represents a novel class of
agents that target unique binding sites on microtubules to disrupt
the cytoskeleton.
Highlights of the Presentation:In this updated
analysis of all 80 patients in the Phase 1b/2 clinical study,
sabizabulin treatment demonstrated both cytotoxic and cytostatic
antitumor activity. Evidence of antitumor activity was observed
with PSA reductions and objective and durable tumor responses. For
patients with measurable disease at baseline (n=29), the overall
response rate was 20.7%. The best clinical response (stable disease
or objective tumor response) in patients with measurable disease at
study entry was 59% (17/29). At the time of data cut off for this
presentation, 5 of the responders remain on study with the longest
approaching 3 years on sabizabulin. Chronic daily dosing with
sabizabulin was feasible and well tolerated with no clinically
relevant neutropenia or neurotoxicity. This Phase1b/2 clinical
study supports the efficacy and safety assumptions for the ongoing
Phase 3 VERACITY clinical study evaluating sabizabulin in
metastatic castration and androgen receptor targeting agent
resistant prostate cancer prior to IV chemotherapy.
Presentation details:Presentation Date/Time:
February 17, 2022Abstract Title: Sabizabulin has both cytotoxic and
cytostatic activity in Phase 1b/2 clinical trials of men with
metastatic castration-resistant prostate cancer who progressed on
androgen receptor-targeting agents.Presenter: Mark C. Markowski MD,
PhD, Assistant Professor, Sidney Kimmel Comprehensive Cancer
Center, Johns Hopkins UniversityAbstract Number: 110
Additional information on the meeting can be found on the ASCO
Genitourinary Cancers Symposium website:
https://conferences.asco.org/gu/attend
“There have been significant advances in the treatment of
metastatic castration resistant prostate cancer with the use of the
latest generation of novel agents that target the androgen receptor
axis. Despite this, almost all patients will have tumor progression
on these agents. An oral, well tolerated drug that can be utilized
prior to patients moving on to intravenous chemotherapy is needed,”
said Mark Markowski, MD, PhD who is presenting the study. “Based
upon these Phase 1b/2 data and assuming that the Phase 3 study
continues to support these findings, sabizabulin appears to have
the appropriate efficacy and safety to fill this unmet medical
need.”
“In this further analysis, we are excited that sabizabulin
continues to demonstrate long-term efficacy in patients from our
Phase 1b/2 study. This may be attributed to its cytotoxic and
cytostatic effects with chronic oral administration of the
sabizabulin which appears to translate to long-term clinical
responses,” said Mitchell S. Steiner, MD, Chairman, President and
Chief Executive Officer of Veru Inc. “We are excited about the
ongoing Phase 3 VERACITY study and moving sabizabulin closer to
potentially providing a novel oral therapy prior to IV
chemotherapy.”
In addition to the presentation on the additional analysis from
the Phase 1b/2 study, a trials in progress presentation will be
given on the Phase 3 VERACITY study that is currently underway.
Presentation details:Presentation Date/Time:
February 17, 2022Abstract Title: Phase 3 VERACITY clinical study of
sabizabulin in men with metastatic castrate resistant prostate
cancer who have progressed on an androgen receptor targeting
agent.Presenter: Robert Dreicer MD, University of Virginia Cancer
CenterAbstract Number: TPS217
About VERACITY Phase 3 Clinical
TrialSabizabulin is a novel oral new chemical entity that
targets unique binding sites in microtubules to disrupt both the
cytoskeleton. In June 2021, the Company initiated the open label,
randomized (2:1), multicenter Phase 3 VERACITY clinical trial
evaluating sabizabulin 32 mg versus an alternative androgen
receptor targeting agent for the treatment of chemotherapy naïve
men with metastatic castration resistant prostate cancer who have
failed at least one androgen receptor targeting agent. The 32 mg
dose formulation being studied in the VERACITY study has similar
bioavailability to the 63 mg dose formulation used in the Phase
1b/2 study. The primary endpoint is median radiographic progression
free survival. The Phase 3 VERACITY clinical trial is anticipated
to enroll approximately 245 patients from 45 clinical centers.
About Veru Inc.Veru is an oncology
biopharmaceutical company with a principal focus on developing
novel medicines for the management of breast and prostate
cancers.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin, a cytoskeleton disruptor.
Current studies on the two drugs include:
- Enrolling Phase 3 ARTEST study of enobosarm in androgen
receptor positive, estrogen receptor positive, and human epidermal
growth factor receptor two negative (AR+ ER+ HER2-) metastatic
breast cancer with AR ≥ 40% expression (third-line metastatic
setting), and which has been granted Fast Track designation by the
FDA.
- Planned Q1 2022 Phase 3 ENABLAR-2 study of enobosarm +
abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2-
metastatic breast cancer with AR ≥ 40% expression (second-line
metastatic setting). The Company has entered into a clinical study
collaboration and supply agreement with Lilly regarding Lilly’s
supply of Verzenio® (abemaciclib) for the ENABLAR-2 study.
- Planned Q1 2022 Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% expression (third-line
metastatic setting).
The Company has determined that patients who have ≥ 40% androgen
receptor nuclei staining by immunohistochemistry in their breast
cancer tissue, a measure of AR expression, are most likely to
respond to enobosarm. Consequently, Veru is developing a companion
diagnostic to determine a patient’s androgen receptor expression
status, and has partnered with Roche/Ventana Diagnostics, a world
leader in oncology companion diagnostics, which will develop and,
if it is approved, commercialize the companion AR diagnostic.
Veru’s late-stage prostate cancer portfolio comprises
sabizabulin, VERU-100, a long-acting GnRH antagonist, and
zuclomiphene citrate, an oral nonsteroidal estrogen receptor
agonist.
Current studies on these drugs include:
- Enrolling Phase 3 VERACITY in metastatic castration and
androgen receptor targeting agent resistant prostate cancer prior
to IV chemotherapy.
- Enrolling Phase 2 dose-finding study of VERU-100 in advanced
hormone-sensitive prostate cancer.
- Planned Phase 2b study of zuclomiphene citrate in men with
advanced prostate cancer undergoing androgen deprivation therapy
who suffer from hot flashes.
In addition, sabizabulin, which has dual antiviral and
anti-inflammatory effects, is currently enrolling in a Phase 3
COVID-19 study for the treatment of hospitalized COVID-19 patients
at high risk for acute respiratory distress syndrome, and which has
been granted Fast Track designation by the FDA.
Veru also has a commercial sexual health division - Urev, the
proceeds of which help fund its drug development programs,
comprised of 2 FDA approved products:
- ENTADFI™ (finasteride and tadalafil) capsules for oral use, a
new treatment for benign prostatic hyperplasia, commercialization
launch plans are underway.
- FC2 Female Condom® (internal condom), for the dual protection
against unplanned pregnancy and the transmission of sexually
transmitted infections which is sold in the U.S. and globally.
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 whether current and future
clinical development and results will demonstrate sufficient
efficacy and safety and potential benefits to secure FDA approval
of the Company’s drug candidates and companion diagnostic; whether
the drug candidates will be approved for the targeted line of
therapy, including sabizabulin in metastatic castration resistant
prostate cancer; the anticipated design and scope for clinical
studies and FDA acceptance of such design and scope, whether any
regulatory pathways, including the accelerated Fast Track
designations, to seek FDA approval for sabizabulin, enobosarm or
any of the Company’s drug candidates are or continue to be
available; whether the expected commencement and timing of the
Company’s clinical studies, including the Phase 3 ENABLAR-2 study,
the sabizabulin monotherapy Phase 2b clinical study for 3rd line
treatment of metastatic breast cancer, the Phase 2 registration
clinical study for VERU-100, and the development of the companion
diagnostic will be met, including the Phase 3 VERU-100 clinical
study and the sabizabulin clinical study for the treatment of
hospitalized Covid-19 patients at high risk of ARDS; when clinical
results from the ongoing clinical studies will be available,
whether sabizabulin, enobosarm, VERU-100, zuclomiphene, and ENTADFI
will serve any unmet need or, what dosage, if any, might be
approved for use in the US or elsewhere, and also statements about
the potential, timing and efficacy of the rest of the Company’s
development pipeline, and the timing of the Company’s submissions
to FDA and FDA’s review of all such submissions; whether any of the
selective clinical properties previously observed in clinical
studies of sabizabulin, enobosarm, VERU-100 or other drug
candidates will be replicated in the current and planned clinical
development program for such drug candidates and whether any such
properties will be recognized by the FDA in any potential approvals
and labeling; whether the companion diagnostic for enobosarm will
be developed successfully or be approved by the FDA for use. 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 studies
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical studies 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 studies, 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; risks relating to the Company's development
of its own dedicated direct to patient telemedicine and
telepharmacy services platform, including the Company's lack of
experience in developing such a platform, potential regulatory
complexity, and development costs; 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, 2021 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.
Verzenio® is a registered trademark of Eli Lilly and Company
Investor and Media Contact:Samuel FischExecutive Director,
Investor Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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