Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical
company with a focus on developing novel medicines for the
management of prostate and breast cancer, announces positive Phase
2 clinical trial results for enobosarm, an oral, novel selective
androgen receptor (AR) targeting agent, for the treatment of
endocrine and chemotherapy resistant ER+/HER2- metastatic breast
cancer, which was selected as a Spotlight Presentation at the 2020
San Antonio Breast Cancer Symposium.
Estrogen receptor (ER) is present in 85% of all breast cancers,
and more than 90% of ER+ positive breast cancers also contain the
AR which has been demonstrated to be an important therapeutic
target in ER+ breast cancer. Enobosarm is an oral drug that
selectively targets the AR in breast cancer without having the
unwanted virilizing androgen adverse side effects including facial
hair, acne, increase in hematocrit, or liver toxicity, while having
potential clinical benefits including increasing muscle and
physical function as well addressing cancer treatment induced bone
loss and fractures. Enobosarm has extensive nonclinical and
clinical experience having been evaluated in 25 separate clinical
studies with 2,091 enrolled patients, including three Phase 2
clinical studies in advanced breast cancer. There are also at least
two enobosarm investigator-initiated Phase 2 clinical studies in
advanced breast cancer.
In the first enobosarm Phase 2 clinical study (G200801),
enobosarm 9mg oral daily dosing was evaluated in 22 heavily
pretreated women who have confirmed AR+/ER+/HER2- metastatic breast
cancer and who have developed resistance to estrogen receptor
targeted endocrine therapies and chemotherapy. In this first Phase
2 clinical study, enobosarm demonstrated a clinically meaningful
six-month clinical benefit rate (complete responses (CR)+partial
responses (PR)+ stable disease (SD)) of 35.3% and had a good safety
profile with no reports of virilization, increased hematocrit, or
liver toxicity.
Today Veru announces the clinical results of the second
enobosarm Phase 2 clinical study (G200802) which were presented at
the 2020 San Antonio Breast Cancer Symposium. This was an
international, Phase 2, open label, parallel design, randomized
study to investigate the efficacy and safety of enobosarm 9mg and
18mg oral daily dosing in 136 heavily pretreated women with
ER+/HER2- metastatic breast cancer who had breast cancer
progression being treated with multiple lines of endocrine therapy
and 90% who had also failed chemotherapy. Patients were randomized
to receive enobosarm 9mg (n=72) or 18mg (n=64) oral daily dosing.
The primary endpoint was clinical benefit rate at 6 months (defined
as CR+PR+SD) by RECIST 1.1. Secondary endpoints included objective
response rate, best overall response rate (complete responses +
partial responses), radiographic progression-free survival (rPFS),
and duration of clinical benefit. Median age was 60.8 years (35-83)
for 9mg and 62.1 years (42-81) for the 18mg cohort. AR positivity
(>10%) was centrally confirmed in 94.0% and 86.5% of the 9mg and
18mg cohorts, respectively.
The Phase 2 primary endpoint demonstrated clinically meaningful
clinical benefit rate of 32% and 29% in the 9mg and 18mg daily
enobosarm AR+ cohorts, respectively. At the time the study was
terminated, the median duration of clinical benefit was not reached
(NR) in the 9mg group (range 8.2 months to NR) and 14.1 months
(range 11.0 to 16.5) in the 18mg group. Best overall response
rates, AR+ patients that had complete or partial responses, were
35.3% and 25.6% for 9mg and 18mg, respectively. The median
progression-free survival was 5.6 months (2.9 to >27.5) and 4.2
months (2.8 to 11) in the 9mg and 18mg groups AR+, respectively.
Women being treated with 9mg or 18mg of enobosarm also reported
significant improvements in quality of life measurements including
mobility, anxiety/depression and pain discomfort. Overall,
enobosarm was well tolerated with most of the observed adverse
events being grade 1 and 2. Drug related severe adverse events
(SAEs) (Grades 3-4) were observed in 6 patients (8.0%) at the 9mg
and 10 patients (16.4%) at the 18mg dose. There were no reports of
virilization, increased hematocrit, and liver toxicity.
In both Phase 2 clinical studies, enobosarm demonstrated
clinically meaningful efficacy and was well tolerated with no
unwanted virilization, no increased hematocrit, and no liver
toxicity in a combined 150 women heavily pretreated women with
ER+/HER2- metastatic breast cancer who have failed estrogen
targeted endocrine therapies and chemotherapy. As the 9mg and 18mg
had similar efficacy, but the 9mg had slightly better tolerability,
the enobosarm 9mg oral daily dose is the recommended dose for the
Phase 3 study.
Based upon the efficacy and safety from these clinical studies,
the FDA recently agreed to the Company’s Phase 3 registration open
label, randomized, ARTEST clinical study to evaluate efficacy and
safety of enobosarm 9mg versus an active comparator (exemestane or
tamoxifen) for the treatment of ER+/HER2- metastatic breast cancer
in approximately 240 patients who have failed a nonsteroidal
aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a
CDK4/6 inhibitor. The primary endpoint will be radiographic
progression-free survival. In the Phase 3 ARTEST study design, the
primary endpoint assumptions anticipate, as this is an earlier
treatment cohort (2nd line of treatment for metastatic disease and
prior to chemotherapy), the median radiographic progression-free
survival will be 7 months for enobosarm treatment group and 3.5
months for the active comparator treatment group. As a comparison
from the scientific literature, the observed median radiographic
progression-free survival for chemotherapy in this treatment
setting is approximately 3.1-3.5 months.
“This Phase 2 study confirms that targeting
the androgen receptor with enobosarm results in clinical efficacy.
Furthermore, enobosarm was well tolerated as evidenced by
improvement in quality of life. These results clearly
support the further clinical development in a Phase 3
study of enobosarm for the treatment of
metastatic endocrine resistant breast cancer. For breast
cancer patients, enobosarm represents a novel class of
targeted endocrine therapy that alternatively targets the androgen
receptor when endocrine therapies targeting the estrogen receptor
stop working,” said Dr. Carlo Palmieri, BSc, MB BS, PhD, FRC,
Professor of Translational Oncology and Consultant Medical
Oncologist, Clatterbridge Cancer Centre NHS Foundation
Trust/University of Liverpool, UK.
“We are extremely excited to have exclusively licensed worldwide
rights to enobosarm to add to our oncology pipeline. Enobosarm is a
large market opportunity as it represents the first new class of
targeted endocrine therapy in ER+ advanced breast cancer in
decades. Enobosarm targets AR in ER+ HER2- metastatic breast cancer
as a potential second line and/or third line oral daily dosing
endocrine therapy option in breast cancer patients that have
exhausted endocrine therapies targeting ER, but prior to
chemotherapy,” said Mitchell Steiner, M.D., Chairman, President and
Chief Executive Officer of Veru. “We expect enobosarm, as a second
line drug for metastatic ER+HER2- breast cancer, will have a median
radiographic progression-free survival of at least 7 months versus
3.5 months for further estrogen receptor targeted endocrine
therapy. Furthermore, based on the scientific literature, when
women receive chemotherapy, their radiographic progression-free
survival was also about 3.5 months, but with all the chemotherapy
side effects. If enobosarm demonstrates efficacy, a good safety
profile, and has the potential additional benefits of improving
quality of life, increasing bone strength, and increasing muscle
and physical function, then it is clear to me that enobosarm as an
AR targeted agent could be the next drug women would consider after
failing ER targeted endocrine therapy and before having
chemotherapy.”
The Principal Investigator for both Phase 2 studies, including
the G200802 study, was Dr. Beth Overmoyer, Founder and Director of
the Inflammatory Breast Cancer Program at the Dana-Farber Cancer
Institute, and Assistant Professor of Medicine, Harvard Medical
School. Presentation was made by Professor Carlo Palmieri of the
Clatterbridge Cancer Centre NHS Foundation Trust / University of
Liverpool, UK.
The authors and affiliations of those included on the study
include Carlo Palmieri1, Hannah Linden2, Stephen Birrell3, Elgene
Lim4, Lee S Schwartzberg5, Hope S Rugo6, Patrick Cobb7, Kirti
Jain8, Charles Vogel9, Joyce A O’Shaughnessy10, Adam Brufsky11 and
Beth Overmoyer12. 1The Clatterbridge Cancer Center NHS Foundation
Trust, Liverpool, United Kingdom; 2University of Washington/
Seattle Cancer Care Associates, Seattle, WA; 3Wellend
Health/Burside Hospital, North Adelaide, Australia; 4University of
New South Wales, Australia and Garvan Institute of Medical
Research, Darlinghurst, Australia; 5The West Clinic, Memphis,
TN;6University of California San Francisco, San Francisco,
CA;7Cancer Centers of Montana, Billings, MT;8Ashland Bellefonte
Cancer Center, Ashland, KY; 9University of Miami Sylvester
Comprehensive Cancer Center, Miami, FL;10Baylor University Medical
Center, Texas Oncology, US Oncology, Dallas, TX; 11Magee-Womens's
Hospital, University of Pittsburgh Medical Center, Pittsburgh,
PA;12Dana Farber Cancer Institute, Boston, MA
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.
The Veru prostate cancer pipeline includes VERU-111, VERU-100, and
Zuclomiphene citrate. VERU-111 is an oral, first-in-class, new
chemical entity that targets, crosslinks, and disrupts alpha and
beta tubulin subunits of microtubules. VERU-111 is being evaluated
in open label Phase 1b and Phase 2 clinical trials in men with
metastatic castration and androgen receptor targeting agent
resistant prostate cancer. The Phase 1b clinical trial completed
enrollment of 39 men and is ongoing. The Phase 2 clinical trial has
completed the enrollment of 40 men who have metastatic castration
resistant prostate cancer and who have also become resistant to at
least one novel androgen receptor targeting agent, such as
abiraterone or enzalutamide, but prior to IV chemotherapy, and is
ongoing. The Company anticipates proceeding to its Phase 3 VERU-111
VERACITY registration clinical trial in the first quarter of
calendar 2021.VERU-111 is also being evaluated in a Phase 2
clinical trial to assess the efficacy of VERU-111 in combating
COVID-19 in subjects at high risk for ARDS. VERU-100 is a novel,
proprietary peptide formulation designed to address the current
limitations of commercially available androgen deprivation
therapies (ADT) for advanced prostate cancer. VERU-100 is a
long-acting gonadotropin-releasing hormone (GnRH) antagonist
administered as a small volume, subcutaneous 3-month depot
injection without a loading dose. VERU-100 immediately suppresses
testosterone with no testosterone surge upon initial or repeated
administration — a problem which occurs with currently approved
luteinizing hormone-releasing hormone (LHRH) agonists used for ADT.
There are no GnRH antagonists commercially approved beyond a
one-month injection. A Phase 2 trial to evaluate VERU100 dosing is
anticipated to begin in the first quarter of calendar year 2021 and
a Phase 3 registration clinical trial is anticipated to begin the
second half of calendar year 2021. Zuclomiphene citrate is an oral
nonsteroidal estrogen receptor agonist being developed to treat hot
flashes, a common side effect caused by ADT in men with advanced
prostate cancer. Following an End of Phase 2 meeting with the FDA,
the Company plans to advance Zuclomiphene citrate to a Phase 3
clinical trial in men with advanced prostate cancer who experience
moderate to severe hot flashes.
The Veru breast cancer pipeline includes enobosarm for hormone
sensitive metastatic ER+/HER2- metastatic breast cancer and
VERU-111 for taxane resistant metastatic triple negative breast
cancer. Enobosarm is an oral, first-in-class, new chemical entity,
selective androgen receptor agonist that targets the androgen
receptor (AR) in AR+/ER+/HER2- metastatic breast cancer without
unwanted virilizing side effects. Enobosarm is the first new class
of targeting endocrine therapy in advanced breast cancer in
decades. In October 2020, the FDA agreed to the Phase 3
registration clinical trial design to evaluate the efficacy and
safety of enobosarm, selective androgen receptor targeting agent,
versus physician’s choice of either exemestane or tamoxifen as an
active comparator for the treatment of metastatic ER+/HER2- breast
cancer in approximately 240 patients who have failed a nonsteroidal
aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a
CDK4/6 inhibitor. The primary endpoint is radiographic
progression-free survival. The pivotal Phase 3, open label,
randomized, active control trial is anticipated to commence in the
first half of calendar year 2021. VERU111 is an oral,
first-in-class, new chemical entity that targets, crosslinks, and
disrupts alpha and beta tubulin subunits of microtubules and is not
a substrate for P-glycoprotein drug resistance protein. Over
expression of P-glycoprotein is a common mechanism that results in
taxane resistance in TNBC. Using the safety information from the
Phase 1b and Phase 2 VERU111 prostate cancer clinical studies in a
total of approximately 80 men, the Company plans to meet with the
FDA in the first half of calendar year 2021 and to commence a Phase
2b registration clinical trial in the second half of calendar year
2021 to evaluate oral daily dosing of VERU111 in approximately 100
women with metastatic TNBC that have become resistant to taxane IV
chemotherapy.
Veru is also advancing a new drug formulation in its specialty
pharmaceutical pipeline addressing unmet medical needs in urology
such as the Tadalafil and Finasteride Combination (TADFYN®) for the
administration of tadalafil 5mg and finasteride 5mg combination
formulation dosed daily for benign prostatic hyperplasia (BPH).
Tadalafil (CIALIS®) is currently approved for treatment of BPH and
erectile dysfunction and finasteride is currently approved for
treatment of BPH (finasteride 5mg PROSCAR®) and male pattern hair
loss (finasteride 1mg PROPECIA®). The co-administration of
tadalafil and finasteride has been shown to be more effective for
the treatment of BPH than by finasteride alone. The Company expects
to submit the NDA for TADFYN® in early calendar year 2021.
The Company’s Sexual Health Business commercial product is the
FC2 Female Condom / FC2 Internal Condom® (“FC2”), an FDA-approved
product for the 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. 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 regulatory pathway to
secure FDA approval of the Company's drug candidates, the
anticipated timeframe for clinical studies and FDA submissions,
clinical study results including potential benefits and the absence
of adverse events and anticipated results of future clinical
trials, and the anticipated design and scope for clinical trials
and FDA acceptance of such design and scope. Any forward-looking
statements in this release are based upon the Company's current
plans and strategies and reflect the Company's current assessment
of the risks and uncertainties related to its business and are made
as of the date of this release. The Company assumes no obligation
to update any forward-looking statements contained in this release
because of new information or future events, developments or
circumstances. Such forward-looking statements are subject to known
and unknown risks, uncertainties and assumptions. If any such risks
or uncertainties materialize or if any of the assumptions prove
incorrect, our actual results could differ materially from those
expressed or implied by such statements. Factors that may cause
actual results to differ materially from those contemplated by such
forward-looking statements include, but are not limited to, the
following: risks related to the development of the Company's
product portfolio, including clinical trials, regulatory approvals
and time and cost to bring to market; potential delays in the
timing of and results from clinical trials and studies, including
potential delays in the recruitment of patients and their ability
to effectively participate in such trials and studies due to
COVID19, and the risk that such results will not support marketing
approval and commercialization; potential delays in the timing of
any submission to the FDA and regulatory approval of products under
development and the risk that disruptions at the FDA caused by the
COVID-19 pandemic may delay the review of submissions or approvals
for new drugs; the risk of a delay or failure in reaching agreement
with the FDA on the design of a clinical trial or in obtaining
authorization to commence a clinical trial; clinical results or
early data from clinical trials may not be replicated or continue
to occur in additional trials or may not otherwise support further
development in the specified product candidate or at all; our
pursuit of a COVID-19 treatment candidate is at an early stage and
we may be unable to develop a drug that successfully treats the
virus in a timely manner, if at all; risks related to our
commitment of financial resources and personnel to the development
of a COVID-19 treatment which may cause delays in or otherwise
negatively impact our other development programs, despite
uncertainties about the longevity and extent of COVID-19 as a
global health concern; government entities may take actions that
directly or indirectly have the effect of limiting opportunities
for VERU-111 as a COVID-19 treatment, including favoring other
treatment alternatives or imposing price controls on COVID-19
treatments; the risk that the Company's products may not be
commercially successful; risks related to the impact of the
COVID-19 pandemic on our business, the nature and extent of which
is highly uncertain and unpredictable; risks relating to the
ability of the Company to obtain sufficient financing on acceptable
terms when needed to fund development and operations, including our
ability to secure timely grant or other funding to develop VERU-111
as a potential COVID-19 treatment; product demand and market
acceptance; competition in the Company's markets and therapeutic
areas and the risk of new or existing competitors with greater
resources and capabilities and new competitive product approvals
and/or introductions; the risk that the Company will be affected by
regulatory developments, including a reclassification of products;
price erosion, both from competing products and increased
government pricing pressures; manufacturing and quality control
problems; compliance and regulatory matters, including costs and
delays resulting from extensive governmental regulation, and
effects of healthcare insurance and regulation, including
reductions in reimbursement and coverage or reclassification of
products; some of the Company's products are in development and the
Company may fail to successfully commercialize such products; risks
related to intellectual property, including the uncertainty of
obtaining patents, the effectiveness of the patents or other
intellectual property protections and ability to enforce them
against third parties, the uncertainty regarding patent coverages,
the possibility of infringing a third party’s patents or other
intellectual property rights, and licensing risks; government
contracting risks, including the appropriations process and funding
priorities, potential bureaucratic delays in awarding contracts,
process errors, politics or other pressures, and the risk that
government tenders and contracts may be subject to cancellation,
delay, restructuring or substantial delayed payments; the risk 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; a
governmental tender award indicates acceptance of the bidder's
price rather than an order or guarantee of the purchase of any
minimum number of units, and as a result government ministries or
other public sector customers may order and purchase fewer units
than the full maximum tender amount or award; penalties and/or
debarment for failure to satisfy tender awards; 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; risks related to
concentration of accounts receivable with our largest customers and
the collection of those receivables; the economic and business
environment and the impact of government pressures; risks involved
in doing business on an international level, including currency
risks, regulatory requirements, political risks, export
restrictions and other trade barriers; 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; risks related
to the 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 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.
Contact:Sam Fisch, Director of Investor
Relations800-972-0538
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