Veru Reaches Agreement with FDA on New Phase 3 Clinical Trial for Sabizabulin for Broader Indication: Hospitalized Adult Patients with Any Type of Viral Acute Respiratory Distress Syndrome (ARDS)
2023年9月26日 - 9:30PM
Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for the treatment of
breast cancer and for viral induced ARDS, today announced that in a
September 21, 2023 meeting, the Company and FDA reached agreement
on the design of a new Phase 3 clinical trial study to evaluate
sabizabulin plus standard of care treatment in an expanded patient
population, hospitalized adult patients who have broadly any type
of virus causing ARDS. The Phase 3 study may suffice as a single
study for NDA submission.
Highlights from the September
21st FDA meeting
FDA agreed to a Phase 3, randomized (1:1), multicenter,
placebo-controlled, parallel group design study to evaluate the
efficacy and safety of sabizabulin 9mg oral daily dose plus
standard of care treatment versus placebo plus standard of care
treatment in hospitalized adult patients with any type of virus
inducing ARDS:
- Novel indication (patient population) for sabizabulin has been
expanded to include all hospitalized adult patients with any type
of viral induced ARDS
- Endpoints:
- Primary efficacy endpoint is all-cause mortality at day 60
- Secondary endpoints include days in the hospital, days in the
ICU, days on mechanical ventilation, and proportion of patients
alive without respiratory failure
- Given the high mortality rate for viral induced ARDS (27-45%),
the expected size of the study is 408 patients
- If Phase 3 study were to demonstrate sufficient benefit on
all-cause mortality at Day 60, then this study could potentially be
sufficient for NDA submission
- As the program has FDA Fast Track designation, a rolling NDA
submission is a possibility for sabizabulin
"As sabizabulin has broad host directed antiviral and
anti-inflammatory activities and an already completed, positive
well controlled and adequate Phase 3 COVID-19 clinical study in
patients at risk for or had ARDS, we felt compelled to reengage
with FDA to consider the possibility of expanding the patient
population to include hospitalized adult patients that have any
type of viral induced ARDS, especially in light of the CDC
expecting a high rate of tripledemic virus hospitalizations this
fall and winter,” said Mitchell Steiner, M.D., Chairman, President
and Chief Executive Officer of Veru. “We are pleased with the
outcome of our meeting with FDA in which they agreed to a Phase 3
study design that allows the treatment of sabizabulin to be
evaluated on top of standard of care in a broader hospitalized
viral induced ARDS patient population. FDA agrees that ARDS is a
well-defined disease with a high mortality rate in which there is a
compelling unmet medical need.”
About Veru Inc.Veru is a late clinical stage
biopharmaceutical company focused on developing novel medicines for
metastatic breast cancer and for viral ARDS.
Oncology program: metastatic breast cancer
The Company’s late-stage breast cancer development portfolio
comprises enobosarm, a selective androgen receptor targeting
agonist.
- Phase 3 clinical ENABLAR-2 study – enobosarm +/- abemaciclib
combination versus estrogen blocking agent (active control) as a
2nd line treatment in AR+ ER+ HER2- metastatic breast
cancer is open and active. The Company and Eli Lilly and Company
have entered into a clinical study collaboration and supply
agreement for the ENABLAR-2 study. Lilly supplies Verzenio®
(abemaciclib).
Infectious disease program: viral ARDS
- COVID-19: Sabizabulin is an
oral, first-in-class, new chemical entity, microtubule disruptor
that has dual anti-inflammatory and host mediated antiviral
properties. Veru has conducted a positive double-blind, randomized,
placebo-controlled Phase 3 COVID-19 clinical trial in 204
hospitalized moderate to severe COVID-19 patients at high risk for
ARDS and death. The primary endpoint was the proportion of deaths
by Day 60. Treatment with sabizabulin resulted in a clinically
meaningful and statistically significant 51.6% relative reduction
in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track
designation to the Company’s COVID-19 program in January
2022. In April 2023, the Company reached agreement with FDA on
design of the Phase 3 confirmatory COVID-19 clinical trial to
evaluate sabizabulin in hospitalized moderate to severe COVID-19
patients at high risk for ARDS. Although the Company reached
agreement with FDA for the design of Phase 3 confirmatory COVID-19
clinical trial, the Company met with FDA in September and reached
agreement on the design of Phase 3 study design evaluating
sabizabulin 9mg for the broader treatment of hospitalized adult
patients who have any type of viral ARDS.
- Smallpox virus: The Company had a pre-IND
meeting in August with FDA to discuss the development of
sabizabulin for smallpox virus. FDA agreed that the Animal Rule
pathway is acceptable for evaluating the efficacy of smallpox
virus. The Company will work with FDA to develop a plan for the
nonclinical studies that could support a smallpox indication.
Sexual health program – Urev
Veru has a commercial sexual health division called Urev that is
comprised of 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. The Company has launched its own independent,
FC2-dedicated direct to patient telehealth and pharmacy services
portal. The Company is focused on executing new contracts with
additional telehealth partners and has internet fulfillment
pharmacy partners that provide coverage in all 50 states in the
U.S.
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: the planned design,
enrollment, timing, commencement, interim and full data readout
timing, scope, regulatory pathways, and results of the Company’s
current and planned clinical trials, including the planned Phase 3
study of sabizabulin in hospitalized adult patients with viral
induced ARDS, the Phase 3 study of enobosarm alone or in
combination with abemaciclib for the 2nd line treatment of AR+ ER+
HER2 metastatic breast cancer, the Phase 3 study of enobosarm in
bone-only non-measurable hormone receptor and HER2- metastatic
breast cancer, the Phase 3 study of sabizabulin in hospitalized
influenza patients at high risk of ARDS, and studies of sabizabulin
in smallpox virus and Ebola virus, and whether any of such studies
will meet any of its primary or secondary endpoint; whether the
results of the planned sabizabulin ARDS study will be sufficient to
support the submission of an NDA and the timing of any such data
reading out; whether the Company will pursue any Phase 3 study of
sabizabulin for COVID-19 alone; whether and when the Company will
receive the future installment payments of the ENTADFI purchase
price or sales milestone payments; and the outlook for growth in
the Company's FC2 business through telehealth customers, our direct
to patient telehealth portal and the global public health sector.
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 as well
as other operations of the Company; the timing of any submission to
the FDA or any other regulatory authority and any determinations
made by the FDA or any other regulatory authority; the possibility
that as vaccines, antivirals and other treatments become widely
distributed the need for new COVID-19 or other ARDS 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 or other
ARDS treatment, including favoring other treatment alternatives or
imposing price controls on COVID-19 or other ARDS treatments; the
Company’s existing products, including FC2 and, if authorized,
sabizabulin, and any future products, if approved, possibly not
being commercially successful; 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; 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, development costs, and
market awareness and acceptance of any telehealth platform we
develop; risks relating to our ability to increase sales of FC2
after significant declines in recent periods due to telehealth
industry consolidation and the bankruptcy of a large telehealth
customer; 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, product testing, transportation delays or regulatory
actions; costs and other effects of litigation, including product
liability claims and securities litigation; 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, 2022 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.
Investor Contact:Samuel FischExecutive Director, Investor
Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
Veru (NASDAQ:VERU)
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