Veru Inc. (NASDAQ: VERU), a biopharmaceutical company, today
announced that results from the randomized placebo-controlled Phase
2 study of daily, oral sabizabulin in patients with severe COVID-19
at high risk for acute respiratory distress syndrome (ARDS) were
presented at the 32nd European Congress of Clinical Microbiology
& Infectious Diseases (ECCMID) being held in Lisbon, Portugal
on April 23-26, 2022.
“The data observed in this small Phase 2 study are quite
dramatic and provided the support for pursuing sabizabulin in the
Phase 3 setting,” said Michael Gordon MD, Chief Medical Officer,
Honor Health Research and Innovation Institute, one of the lead
investigators on the study. “We need a safe drug that can be
utilized in the most severely ill COVID-19 patients to save lives
and sabizabulin appears to meet this need.”
“We are very excited about the clinically meaningful reduction
in deaths in hospitalized COVID-19 patients at high risk for ARDS
and death being presented from this Phase 2 study. The clinically
meaningful and statistically significant reduction in deaths in
this high risk population was confirmed in a Phase 3 COVID-19 study
which was stopped for overwhelming efficacy based on a planned
interim analysis, said Mitchell S. Steiner MD, Chairman, President
and Chief Executive Officer of Veru Inc. “Sabizabulin appears to
have the ability to prevent deaths in the sickest of COVID-19
patients and we are working diligently to bring sabizabulin to
these patients.”
The oral, late-breaking presentation was given during Session 12
– Current treatment approach to COVID-19 and was held on April 23,
2022 at 11:15 AM – 1:15 PM EDT.Abstract number:
4407Presentation title: Phase 2 study of oral
sabizabulin for the treatment of SARS-CoV-2 in hospitalized
patients at high risk for ARDSPresentation being given
by: Michael Gordon MD, Chief Medical Officer at
HonorHealth Research and Innovation Institute in Scottsdale,
Arizona
Phase 2 Trial Design: Veru conducted a
double-blind, randomized, placebo-controlled Phase 2 clinical trial
evaluating oral, once-a-day dosing of sabizabulin versus placebo in
approximately 40 hospitalized COVID-19 patients who were at high
risk for ARDS. The trial was conducted in five sites across the
United States. Patients hospitalized with documented evidence of
COVID-19 infection and at high risk for ARDS were enrolled.
Subjects received daily oral dosing of sabizabulin or placebo, as
well as standard of care for 21 days or until released from
hospital. The primary efficacy endpoint was the proportion of
patients alive without respiratory failure at Day 29. Respiratory
failure was defined as endotracheal intubation and mechanical
ventilation, extracorporeal membrane oxygenation, high-flow nasal
cannula oxygen delivery, noninvasive positive pressure ventilation,
and/or clinical diagnosis of respiratory failure with initiation of
none of these measures only when clinical decision making is driven
solely by resource limitation.
Results: In this cohort of patients with severe
COVID-19, sabizabulin treatment resulted in an 82% relative
reduction in deaths (p=0.0442) in the ITT population. Further,
sabizabulin treatment resulted in a reduction in mean days in the
ICU from 9.6 ± 12.40 days in the placebo group to 2.6 ± 5.78 days
(p=0.0261) in the sabizabulin treated group, a 73% relative
reduction in the mean days in the ICU. Similarly, there was a
reduction in mean days on mechanical ventilation from 5.1 ± 11.24
days in the placebo group to 1.2 ± 6.06 days (p=0.1437), a 78%
relative reduction in days on mechanical ventilation. Sabizabulin
was safe and well tolerated with no treatment related adverse
events observed on the study.
The severity of the COVID-19 infection at baseline, as measured
by the WHO scale, was a significant predictor of patient outcomes.
The disease severity at baseline was not different between the
treatment groups.
About Veru Inc.Veru is a biopharmaceutical
company with a principal focus 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 followup, 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 and an advance purchase agreement from the US
Government. 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 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 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; 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
FischExecutive Director, Investor Relations and Corporate
CommunicationsEmail: veruinvestor@verupharma.com
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