Veru Inc. (NASDAQ: VERU) today announced that the Independent Data
Monitoring Committee (IDMC) has conducted a planned conditional
power analysis of the first 75 randomized patients in the Global
Phase 3 COVID-19 registration study evaluating novel oral
sabizabulin in hospitalized patients with moderate to severe
COVID-19 infection who are at high risk for acute respiratory
distress syndrome (ARDS) and death and has concluded the clinical
study should continue as originally designed. The IDMC performed
this planned conditional statistical power analysis and review of
safety of the first 75 study patients to reach the primary
endpoint. Current full study recruitment is on track to yield
clinical results in the first half of calendar year 2022.
The Phase 3 COVID-19 clinical study is a double-blind,
multicenter, multinational, randomized (2:1), placebo-controlled
study evaluating daily oral 9 mg sabizabulin for up to 21 days
versus placebo in 300 hospitalized patients who have moderate to
severe infection and who are at high risk for ARDS. Subjects will
also be allowed to receive standard of care. The primary efficacy
endpoint will be the proportion of patients that die on study up to
Day 60. Secondary endpoints will include the proportion of patients
without respiratory failure, days in ICU, WHO Ordinal Scale for
Clinical Improvement change from baseline, days on mechanical
ventilation, days in the hospital, and viral load.
In January 2022, the Phase 3 COVID-19 program received Fast
Track designation by FDA. Fast Track designation aims to expedite
the development and review of new drugs that are intended to treat
serious or life-threatening conditions and demonstrate the
potential to fill unmet medical needs. Filling an unmet medical
need is defined as providing a therapy where none exists or
providing a therapy which may be potentially better than available
therapy.
The Phase 3 COVID-19 study is being conducted in the United
States, Brazil, Argentina, Mexico, Colombia and Bulgaria and is on
track. Clinical results are expected in the first half of calendar
year 2022.
“This conditional power analysis reviewed the clinical efficacy
data from the first 75 patients to make a determination whether the
study should be stopped for lack of efficacy, or continue as
planned as the current study design and sample size are
appropriate,” said Mitchell Steiner, M.D., Chairman, President and
Chief Executive Officer of Veru Inc. “We are pleased that the
Independent Data Monitoring Committee has confirmed that based on
this conditional statistical power analysis we should continue the
study as planned. The Phase 3 COVID-19 clinical study is on track
to have clinical results the first half of this year.”
Dr. Steiner further noted: “COVID-19 global cases are at
exceedingly high levels. In fact, the Omicron variant has driven
the US death toll higher than at any point during the Fall of
2021’s Delta variant peak. It is clear that an effective and safe
oral therapeutic that prevents deaths in hospitalized patients with
moderate to severe COVID-19 disease who are at high risk for ARDS
is desperately needed. FDA has confirmed by granting Fast Track
that an effective therapy for hospitalized patients with COVID-19
remains an unmet medical need. We strongly believe that sabizabulin
with its anti-viral and anti-inflammatory properties and a
favorable safety profile may be that greatly needed oral therapy
for these hospitalized COVID-19 patients at risk for ARDS.”
About Sabizabulin for COVID-19Microtubule
trafficking is critical for viruses to be transported, replicated,
assembled, and released from the cell. Microtubules also play a
role in the inflammatory process including the cytokine release
syndrome (cytokine storm). Sabizabulin is a cytoskeleton disruptor
which blocks microtubule trafficking and has the potential to treat
both the SARS-CoV-2 viral infection and the cytokine storm and
septic shock that leads to ARDS and the high COVID-19 mortality
rates.
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, including whether sabizabulin
will be an effective therapy for hospitalized COVID-19 patients,
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; 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; when commercial launch of ENTADFI will
occur and the Company’s ability to develop its own direct to
patient telemedicine and telepharmacy services platform to market
and distribute ENTADFI; the magnitude of any potential revenues
generated by ENTADFI; whether the companion diagnostic for
enobosarm will be developed successfully or be approved by the FDA
for use; that demand for the FC2 in the US prescription business
and the Company’s commercial products, including FC2 and ENTADFI,
will continue and further financially support the Company’s
clinical oncology development pipeline; and whether and when the
Company will launch its own telemedicine and internet pharmacy
services platforms to market either FC2 or ENTADFI and whether
either such platform will increase awareness or drive sales of such
products. 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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