FDA Has Granted Veru a Pre-Emergency Use Authorization (EUA) Meeting Date for Positive Sabizabulin Phase 3 COVID-19 Study
May 02 2022 - 8:30AM
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, today
announced that the FDA has granted the Company a pre-Emergency Use
Authorization (EUA) meeting on May 10, 2022, for the positive Phase
3 COVID-19 study for sabizabulin.
“We want to keep our investors informed of the important steps
as we proceed through the EUA process. We appreciate FDA’s actions
to expedite this process as COVID-19 cases are on the rise again,”
said Mitchell S. Steiner MD, Chairman, President and Chief
Executive Officer of Veru Inc.
About Veru Inc.
Veru is a biopharmaceutical company focused on developing novel
medicines for COVID-19 and other viral and ARDS-related diseases
and for the management of breast and prostate cancers.
A double-blind, randomized, placebo-controlled Phase 3 COVID-19
clinical trial was conducted in approximately 210 hospitalized
COVID-19 patients with moderate to severe COVID (≥ WHO 4) at high
risk for ARDS and death. The primary endpoint was the proportion of
deaths by Day 60. Based on a planned interim analysis of the first
150 patients to complete 60 days of follow-up, the Independent Data
Monitoring Committee unanimously halted the study for overwhelming
efficacy and safety. Treatment with sabizabulin 9mg once daily, an
oral, first-in-class, new chemical entity, cytoskeleton disruptor
that has dual anti-inflammatory and antiviral properties, resulted
in a clinically meaningful and statistically significant 55%
relative reduction in deaths. The Company is seeking FDA emergency
use authorization. FDA granted Fast Track designation to the
Company’s COVID-19 program in January 2022.
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist, and sabizabulin.
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.
- Enrolling 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 and Eli Lilly and Company have entered into a clinical
study collaboration and supply agreement for the ENABLAR-2 study.
Lilly will supply Verzenio® (abemaciclib).
- Planned Phase 2b study of sabizabulin in AR+ ER+ HER2-
metastatic breast cancer with AR < 40% expression (third-line
metastatic setting).
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 study 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 to treat hot
flashes in men with advanced prostate cancer undergoing androgen
deprivation therapy.
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, for which
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 and when the Company
will meet with FDA, submit an EUA application, or receive an
emergency use authorization or any approval from FDA for
sabizabulin for certain COVID-19 patients; whether and when
sabizabulin will become an available treatment option for certain
COVID-19 patients; whether the Company will have sufficient supply
of sabizabulin to meet demand, if an emergency use authorization or
other approval is granted; whether the Company will secure any
advance purchase agreement with the U.S. government; whether the
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; the anticipated design and scope
of 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; 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 U.S. 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; and whether and when ENTADFI will be
commercialized successfully. 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 Fisch Executive Director,
Investor Relations and Corporate Communications Email:
veruinvestor@verupharma.com
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