MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced that an
abstract regarding MediciNova’s ongoing Phase 2b/3 clinical trial
of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) has
been accepted for presentation at the 32nd International Symposium
on ALS/MND (amyotrophic lateral sclerosis/motor neurone disease) to
be held virtually on December 7 - 10, 2021.
The presentation entitled "COMBAT-ALS
Phase 2b/3 Trial of MN-166 (ibudilast) in ALS: Trial
Update” will be given by Kazuko Matsuda, M.D. Ph.D.
M.P.H., Chief Medical Officer, MediciNova, Inc. Presentation
details will be disseminated as they become available.
“We are very pleased to present ongoing
activities from the COMBAT-ALS trial at the 32nd International
Symposium on ALS/MND. The purpose of presenting at this symposium
attended by ALS/MND researchers, clinicians, and patients is to
share information about this important trial to a greater number of
stakeholders in the ALS community. We want to express our deep
gratitude to patients who volunteer to participate in our trial, as
well as those who conduct the trial at their fine institutions,”
commented Dr. Yuichi Iwaki, M.D. Ph.D., President and Chief
Executive Officer, MediciNova, Inc.
About the COMBAT-ALS
Trial
This is a Phase 2b/3, multicenter, randomized,
double-blind (12 months), placebo-controlled, parallel group study
to evaluate the efficacy, safety, and tolerability of MN-166
(ibudilast) followed by an open-label extension phase (6 months) in
patients with ALS. Patients who meet entry criteria will be
randomly assigned 1:1 to one of two treatment groups, 100 mg/day of
MN-166 (ibudilast) or matching placebo. It is planned to enroll 230
subjects at 30 sites in the U.S., Canada, and Europe (NCT04057898).
The primary endpoint is change from baseline in ALSFRS-R score at
Month 12 (or last observation before death in case of censoring)
and survival time. Secondary endpoints include safety and
tolerability, responder analysis (stability or improvement in
ALSFRS-R score over 12 months), muscle strength, and quality of
life. To provide further education on the potential of MN-166
(ibudilast) to treat patients with ALS, an informational webinar
presented by MediciNova features Dr. Björn Oskarsson, lead clinical
investigator of COMBAT-ALS, and Dr. Benjamin Rix Brooks, who led
the first clinical study of MN-166 (ibudilast) in patients with
ALS, provides an overview of the drug’s mechanism of action, the
COMBAT-ALS study design, and findings from the Phase 2 trial in
ALS. A replay of the webinar can be viewed here.
About ALS
Amyotrophic lateral sclerosis (ALS), also known
as Lou Gehrig's disease, is a progressive neurodegenerative disease
that affects nerve cells in the brain and the spinal cord. The
nerves lose the ability to trigger specific muscles, which causes
the muscles to become weak. As a result, ALS affects voluntary
movement and patients in the later stages of the disease may become
completely paralyzed. Life expectancy of an ALS patient is usually
2-5 years. According to the ALS Association, there are
approximately 16,000 ALS patients in the U.S. and approximately
5,000 people in the U.S. are diagnosed with ALS each year.
About MN-166
(ibudilast)
MN-166 (ibudilast) is a small molecule compound
that inhibits phosphodiesterase type-4 (PDE4) and inflammatory
cytokines, including macrophage migration inhibitory factor (MIF).
It is in late-stage clinical development for the treatment of
neurodegenerative diseases including ALS, progressive MS (multiple
sclerosis), and DCM (degenerative cervical myelopathy);
glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy),
and substance use disorder. In addition, MN-166 (ibudilast) is
being evaluated in patients at risk for developing acute
respiratory distress syndrome (ARDS).
About MediciNova
MediciNova, Inc. is a clinical-stage
biopharmaceutical company developing a broad late-stage pipeline of
novel small molecule therapies for inflammatory, fibrotic, and
neurodegenerative diseases. Based on two compounds, MN-166
(ibudilast) and MN-001 (tipelukast), with multiple mechanisms of
action and strong safety profiles, MediciNova has 11 programs in
clinical development. MediciNova’s lead asset, MN-166 (ibudilast),
is currently in Phase 3 for ALS and DCM and is Phase 3-ready for
progressive MS. MN-166 (ibudilast) is also being evaluated in Phase
2 trials in glioblastoma, patients at risk of developing ARDS, and
substance dependence. MN-001 (tipelukast) was evaluated in a Phase
2 trial in idiopathic pulmonary fibrosis (IPF) and is in
preparation for a second Phase 2 trial in nonalcoholic
steatohepatitis (NASH). MediciNova has a strong track record of
securing investigator-sponsored clinical trials funded through
government grants.
Statements in this press release that are not
historical in nature constitute forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, without limitation, statements regarding the future
development and efficacy of MN-166, MN-001, MN-221, and MN-029.
These forward-looking statements may be preceded by, followed by or
otherwise include the words "believes," "expects," "anticipates,"
"intends," "estimates," "projects," "can," "could," "may," "will,"
"would," “considering,” “planning” or similar expressions. These
forward-looking statements involve a number of risks and
uncertainties that may cause actual results or events to differ
materially from those expressed or implied by such forward-looking
statements. Factors that may cause actual results or events to
differ materially from those expressed or implied by these
forward-looking statements include, but are not limited to, risks
of obtaining future partner or grant funding for development of
MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient
capital when needed to fund MediciNova's operations and
contribution to clinical development, risks and uncertainties
inherent in clinical trials, including the potential cost, expected
timing and risks associated with clinical trials designed to meet
FDA guidance and the viability of further development considering
these factors, product development and commercialization risks, the
uncertainty of whether the results of clinical trials will be
predictive of results in later stages of product development, the
risk of delays or failure to obtain or maintain regulatory
approval, risks associated with the reliance on third parties to
sponsor and fund clinical trials, risks regarding intellectual
property rights in product candidates and the ability to defend and
enforce such intellectual property rights, the risk of failure of
the third parties upon whom MediciNova relies to conduct its
clinical trials and manufacture its product candidates to perform
as expected, the risk of increased cost and delays due to delays in
the commencement, enrollment, completion or analysis of clinical
trials or significant issues regarding the adequacy of clinical
trial designs or the execution of clinical trials, and the timing
of expected filings with the regulatory authorities, MediciNova's
collaborations with third parties, the availability of funds to
complete product development plans and MediciNova's ability to
obtain third party funding for programs and raise sufficient
capital when needed, and the other risks and uncertainties
described in MediciNova's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2020 and its subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date hereof. MediciNova disclaims any intent or obligation to
revise or update these forward-looking statements.
INVESTOR CONTACT:
Geoff O'Brien
Vice PresidentMediciNova,
Inc.info@medicinova.com
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