Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical
company focused on developing novel medicines for metastatic breast
cancer and for viral induced acute respiratory distress syndrome
(ARDS), today announced clinical data from the discontinued Phase 3
ARTEST clinical trial of enobosarm monotherapy for the 3rd line or
greater in the metastatic setting of AR+ER+HER2- breast cancer.
Enrollment was discontinued in order to prioritize and focus the
clinical development of enobosarm therapy earlier in the treatment
sequence, the 2nd line metastatic setting, for AR+ER+HER2-
metastatic breast cancer in the Phase 3 ENABLAR-2 (enobosarm +/-
abemaciclib CDK 4/6 inhibitor) study. Data reported from the
discontinued trial, which is based on an analysis of available
data, may not be predictive of the results of larger, later-stage
controlled clinical trials.
Highlights of clinical data from discontinued Phase 3
ARTEST clinical study
At the time enrollment was stopped, there were 34 evaluable
patients randomized to either 9mg enobosarm monotherapy (n=16) or a
standard of care active control (n=18) in the Phase 3 open label,
randomized (1:1) clinical trial for the treatment of AR+ER+HER2-
metastatic breast cancer with sufficient AR expression in their
breast cancer tissue who had previously received at least a
nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6
inhibitor.
Active control treatment group received an average of 2.6 (range
1-5) and enobosarm 9mg monotherapy an average of 2.9 (range 1-5)
prior lines of treatment. On average, enobosarm or the active
control was given in the 4th line treatment for AR+ER+HER2-
metastatic breast cancer.
Summary of Overall Response Rate Data*:
|
Enobosarm monotherapy |
Estrogen blocking agentactive
control |
Evaluable patients |
2 PR /16 (12.5%) |
0 PR/18 (0%) |
Evaluable patients - including an unconfirmed
response |
3 PR /16 (18.8%) |
0 PR/18 (0%) |
Patients with ≤3 lines of prior endocrine therapy |
2 PR /10 (20%) |
0 PR/15 (0%) |
Patients with ≤3 lines of prior endocrine therapy with ≤1 prior
treatment with CDK 4/6 inhibitor |
2 PR /6 (33.3%) |
0 PR/10 (0%) |
*unaudited data, overall response rate = partial response (PR) +
complete response (CR)
Safety: Enobosarm monotherapy was generally
well tolerated without masculinizing adverse events or increases in
hematocrit.
“Enobosarm is a new and different hormone agent that targets the
androgen receptor to suppress metastatic breast cancer with
potential improvements in quality of life without the unwanted
masculinizing side effects and increase in hematocrit typically
associated with androgens,” said Mitchell Steiner, M.D., Chairman,
President and Chief Executive Officer of Veru.
“The clinical results from the ARTEST study provide promising
scientific support and validation for the potential of enobosarm
therapy in the ongoing Phase 3 ENABLAR-2 study. The AR+ER+HER2-
metastatic breast cancer patients enrolled in the Phase 3 ARTEST
study were heavily pretreated. On average, either enobosarm or the
standard of care active control in ARTEST was given as 4th line
treatment. Although sicker patients and smaller sample size, the
antitumor activity and safety of enobosarm are promising. Tumor
response rates of 20% for enobosarm monotherapy versus 0% for
active control in patients with ≤3 lines of prior therapy are
highly encouraging because they represent a patient population that
is similar to that being tested in ENABLAR-2. Additionally, this is
consistent with what we observed in the Phase 2 (G200802) study
where enobosarm treatment resulted in a tumor response rate of 3/10
(30%) in a subgroup of heavily pretreated ER+HER2- metastatic
breast cancer patients who also had a prior CDK 4/6 inhibitor. To
put these tumor response rates into context, it has been reported
that treatment with either elacestrant (selective estrogen receptor
degrader) or standard of care treatment in the 2nd line metastatic
setting in ER+HER2- metastatic patients who had tumor progression
following CDK 4/6 inhibitor treatment resulted in tumor response
rates of about 4.5%.”
“Based on the ARTEST study, our expectation for the ENABLAR-2
study is that enobosarm could have greater activity either as
monotherapy or in combination with abemaciclib compared to an
estrogen blocking agent active control earlier in the treatment
sequence, 2nd line treatment, for AR+ER+HER2- metastatic breast
cancer after receiving a prior CDK 4/6 inhibitor + estrogen
blocking agent. In fact, in stage 1 of the ENABLAR-2 study, we have
already observed 2 partial responses in the first 3 patients
enrolled who were treated with enobosarm 9mg plus abemaciclib
combination in the 2nd line metastatic setting after having tumor
progression while receiving CDK 4/6 inhibitor plus an estrogen
blocking agent. We are encouraged by these early results, and it
appears to be the right decision to move and focus enobosarm’s
clinical development earlier to the 2nd line metastatic setting for
ER+HER2- metastatic breast cancer patients in the Phase 3 ENABLAR-2
study.”
About Enobosarm
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 approximately 1450 dosed patients, including three
Phase 2 clinical studies in advanced breast cancer.
About Phase 3 ENABLAR-2 clinical study:
Phase 3 clinical ENABLAR-2 study – Enobosarm +/- abemaciclib
(CDK 4/6 inhibitor) combination versus estrogen blocking agent
(active control) as a 2nd line treatment for
AR+ ER+ HER2- metastatic breast cancer
In March 2023, the Company announced that it was prioritizing
the clinical development of enobosarm in the Phase 3 ENABLAR-2
(enobosarm +/- abemaciclib CDK 4/6 inhibitor) in the 2nd line
metastatic setting in AR+ER+HER2- breast cancer and discontinuing
the Phase 3 ARTEST (enobosarm monotherapy) clinical study in the
3rd line metastatic setting in AR+ER+HER2- breast cancer. Reasons
the company prioritized the development of enobosarm in the Phase 3
ENABLAR-2 study included:
- The desire to focus enobosarm treatment earlier in a
potentially more responsive, 2nd line metastatic setting in the
sequence of therapies for patients with ER+HER2- breast cancer
- 2nd line treatment is a larger patient population than 3rd line
or greater in the metastatic setting for ER+HER2- breast
cancer
- The Phase 3 ENABLAR-2 and the Phase 3 ARTEST studies had an
overlapping target patient population based on current and evolving
standards of care, therefore closing the ARTEST study would
decrease competition for the recruitment of similar patients
- Veru has a clinical collaboration and supply agreement for
abemaciclib with Eli Lilly for the Phase 3 ENABLAR-2 study
On March 30, 2023, the Company met with the FDA to gain
further agreement on Phase 3 clinical trial design and program. The
Phase 3 study has been amended to accommodate the FDA’s latest
recommendations to support registration as a second line treatment
for patients with AR+ ER+ HER2- metastatic breast cancer
who have tumor progression while receiving a CDK 4/6 inhibitor plus
an estrogen blocking agent (nonsteroidal aromatase inhibitor or
selective estrogen receptor degrader). The Phase 3 ENABLAR-2 study
has 2 distinct study stages:
In Stage 1 of the Phase 3 study which will enroll 160 patients,
the objectives are to optimize the dose of enobosarm in the
abemaciclib combination and to assess the efficacy of enobosarm as
a monotherapy compared to an estrogen blocking agent active
control. The primary endpoint for Stage 1 is ORR. The Stage 1
initial run-in enrolled 3 patients to assess the safety and
pharmacokinetics of the abemaciclib + enobosarm 9mg combination. In
this run-in portion, there were no drug-to-drug interactions
between abemaciclib and enobosarm, and there were no new safety
findings. Further, the early preliminary clinical results showed 2
partial responses and 1 stable disease in the first 3 patients
based on local assessments, and all patients have been on study for
over 9 months. Our current plan is to have Phase 3 Stage 1 clinical
results by late 2024 or early 2025. If enobosarm monotherapy or
abemaciclib + enobosarm combination therapy compared to estrogen
blocking agent (active control) demonstrates significant
improvement in ORR, which is considered a surrogate endpoint for
clinical benefit, then the Company plans to meet with the FDA to
consider an accelerated approval regulatory pathway based on the
clinical data from the Stage 1 portion of the Phase 3 study.
In Stage 2 of the Phase 3 study, we plan to enroll approximately
200 subjects in a multicenter, open label, randomized (1:1), active
control clinical study, to evaluate the efficacy and safety of
enobosarm with or without abemaciclib therapy (depending on the
outcome of Stage 1) versus an alternative estrogen blocking agent
(selective estrogen receptor degrader or an aromatase inhibitor) in
subjects with AR+ ER+ HER2- metastatic breast cancer who
have failed a CDK 4/6 inhibitor plus an estrogen blocking agent
(nonsteroidal aromatase inhibitor or selective estrogen receptor
degrader). The primary endpoint for Stage 2 of the Phase 3 study is
progression-free survival.
In January 2022, Veru entered into a clinical trial
collaboration and supply agreement through which Eli Lilly supplies
abemaciclib for the ENABLAR-2 trial.
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.
- Enrolling 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. 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 has reached
agreement with FDA for the design of Phase 3 confirmatory COVID-19
clinical trial, the Company now plans to meet with FDA to reach
agreement on the design of a proposed expanded Phase 3 confirmatory
study evaluating sabizabulin 9mg for the treatment of hospitalized
adult patients who have and type of viral lung infection and on
oxygen support who are at high risk for ARDS and death. The FDA has
granted a meeting with Veru for September 2023.
- Smallpox and Ebola viruses: The Company is
planning a pre-IND meeting with FDA to discuss the development of
sabizabulin for Ebola virus under the Animal Rule FDA regulatory
approval pathway. Veru had pre-IND meeting with FDA in August 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 confirmatory
Phase 3 study of sabizabulin for certain COVID-19 patients, the
Phase 3 study of enobosarm 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 ENABLAR-2 study will show results
consistent with or greater than the ARTEST results reported above;
whether and when any of the planned interim analyses in the planned
Phase 3 confirmatory study of sabizabulin for certain COVID
patients will occur and what the results of any such interim
analyses will be; whether the results of such interim analyses or
the completed confirmatory Phase 3 study or any other interim data
will be sufficient to support a new EUA application or an NDA;
whether and when the Company will expand the study of sabizabulin
into other ARDS indications; 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, anti-virals 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 and Media Contact:
Samuel FischExecutive Director, Investor
Relations and Corporate CommunicationsEmail:
veruinvestor@verupharma.com
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