MediciNova, Inc., a biopharmaceutical company traded on
the NASDAQ Global Market (NASDAQ:MNOV) and the Standard
Market of the Tokyo Stock Exchange (Code Number: 4875),
today announced that Principal Investigator, Lara Ray, PhD,
Professor, Department of Psychology, University of California Los
Angeles (UCLA) presented the results of the Phase 2b trial of
MN-166 (ibudilast) in alcohol use disorder (AUD) at the 46th Annual
Research Society on Alcoholism (RSA) Scientific Meeting held June
24 - 28, 2023, in Bellevue, Washington.
The clinical trial was a collaborative effort
between MediciNova and Dr. Lara Ray, Professor, Department of
Psychology and Department of Psychiatry and Biobehavioral Sciences,
Brain Research Institute at UCLA, and was funded by the National
Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of
the National Institutes of Health (NIH).
This study was a randomized, double-blind,
placebo-controlled, Phase 2b clinical trial in treatment-seeking
men and women with moderate or severe AUD. Participants took MN-166
(ibudilast) 50 mg or placebo twice a day for 12 weeks. A total of
102 subjects were enrolled in this trial. The primary objective of
the trial was to evaluate the effects of MN-166 (ibudilast) vs.
placebo on percent heavy drinking days defined as ≥5 drinks for men
and ≥4 drinks for women over the course of a 12-week treatment
period.
MN-166 (ibudilast) treatment was not superior to
placebo for reducing percent heavy drinking days. Also, MN-166
(ibudilast) treatment was not superior to placebo for the secondary
endpoints of 1) the number of drinks consumed per day, 2) the
number of drinks consumed per drinking day, 3) the percentage of
days abstinent, 4) the percentage of subjects with no heavy
drinking days, and 5) the percentage of subjects who are
abstinent.
Kazuko Matsuda MD, PhD, MPH, Chief Medical
Officer of MediciNova, Inc. commented, “Unfortunately,
there was no evidence of efficacy of MN-166 treatment for AUD in
this study population, the first study targeting
“treatment-seeking” individuals who met the criteria for moderate
or severe AUD. We observed a so-called placebo effect – both
placebo and MN-166 treatments decreased heavy drinking by equal
magnitudes. We look forward to future discussions with Dr. Ray on
further analyses, including subgroup analyses, and the future
direction of MN-166 and AUD.”
About the Clinical Trial
This study was a randomized, double-blind,
placebo-controlled, outpatient clinical trial that targeted
treatment-seeking men and women who met current DSM-5 diagnostic
criteria for moderate or severe AUD. Participants took MN-166
(ibudilast) 50 mg or placebo twice a day for 12 weeks and completed
the NIAAA-developed computer-delivered program “Take Control”
during the study. The primary objective of the trial was to test
whether MN-166 (ibudilast) will decrease percent heavy drinking
days (defined as ≥5 drinks for men and ≥4 drinks for women), as
compared to placebo, over the course of the 12-week treatment
period. The secondary objectives were to evaluate the efficacy of
MN-166 (ibudilast) on 1) the number of drinks consumed per day, 2)
the number of drinks consumed per drinking day, 3) the percentage
of days abstinent, 4) the percentage of subjects with no heavy
drinking days, and 5) the percentage of subjects who were
abstinent, as well as measures of alcohol craving and negative
mood, over the course of the 12-week treatment period. Exploratory
endpoints included evaluation of whether the effects of MN-166
(ibudilast) on the primary and secondary endpoints are moderated by
depressive symptomatology and whether MN-166 (ibudilast) reduces
neuroinflammation over the course of the 12-week treatment
period.
About Alcohol Use Disorder
Alcohol use disorder (AUD) is a prevalent and
disabling psychiatric disorder with limited treatment options.
AUD is a chronic relapsing brain disease characterized by
compulsive alcohol use, loss of control over alcohol intake, and a
negative emotional state when not using alcohol. According to
the National Institute on Alcohol Abuse and
Alcoholism (NIAAA), an estimated 29.5 million people in the
U.S. have AUD and only 5% received treatment for the disease in the
past year. There is a high unmet medical need for better treatments
for AUD.
About MN-166
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 such as ALS (amyotrophic lateral
sclerosis), progressive MS (multiple sclerosis), and DCM
(degenerative cervical myelopathy); and is also in development for
glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy),
Long COVID, and substance use disorder. In addition, MN-166
(ibudilast) was evaluated in patients that are 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 amyotrophic lateral sclerosis (ALS) and
degenerative cervical myelopathy (DCM) and is Phase 3-ready for
progressive multiple sclerosis (MS). MN-166 (ibudilast) is also
being evaluated in Phase 2 trials in glioblastoma, Long COVID, and
substance dependence. MN-001 (tipelukast) was evaluated in a Phase
2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2
trial in non-alcoholic fatty liver disease (NAFLD) is ongoing.
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, 2022 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: |
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Geoff O'Brien |
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Vice President |
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MediciNova, Inc. |
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info@medicinova.com |
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