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 positive
results from a Phase 2 trial of MN-166 (ibudilast) in alcohol use
disorder (AUD) were published in Nature’s Translational Psychiatry.
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 the University of California at Los Angeles
(UCLA) and was funded by the Center for Study of Opioid
Receptors and Drugs of Abuse (CSORDA; National Institute
on Drug Abuse Grant P50-DA005010). This study was a randomized,
double-blind, placebo-controlled Phase 2 trial to evaluate the
effect of 14 days of ibudilast treatment on mood, heavy drinking,
and neural reward signals in individuals with AUD. A total of 52
AUD patients were enrolled in this trial.
The publication, entitled “Ibudilast, a neuroimmune
modulator, reduces heavy drinking and alcohol cue-elicited neural
activation: a randomized trial” was authored by Dr. Lara Ray and
colleagues at UCLA.
Key results reported in the publication include the
following:
- Ibudilast did not have a
significant effect on negative mood.
- Ibudilast, relative to placebo,
reduced the odds of heavy drinking across time by 45% (OR=0.55,
(95% CI: 0.30, 0.98)).
- Ibudilast attenuated alcohol
cue-elicited activation in the ventral striatum (VS) compared to
placebo (p=0.01).
- Alcohol cue-elicited activation in
the VS predicted subsequent drinking in the ibudilast group
(p=0.02), such that individuals who had attenuated ventral striatal
activation and took ibudilast had the fewest number of drinks per
drinking day in the week following the scan.
- Ibudilast reduced alcohol craving
compared to placebo on non-drinking days (p=0.02).
- These findings extend preclinical
and human laboratory studies of the utility of ibudilast to treat
AUD and suggest a biobehavioral mechanism through which ibudilast
acts, namely, by reducing the rewarding response to alcohol cues in
the brain leading to a reduction in heavy drinking.
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer
of MediciNova, Inc., commented, “We are very pleased that the
results from this Phase 2 trial in alcohol use disorder
have been published. We are excited that MN-166 reduced the odds of
heavy drinking by 45% after only 14 days of treatment. Our first
clinical trial demonstrated that ibudilast significantly reduced
basal, daily alcohol craving in AUD patients. We are thrilled that
MN-166 has demonstrated great potential to reduce the increasing
problem of alcohol use disorder.”
Professor Lara Ray commented, “During the COVID-19 pandemic,
uncertainty, unemployment, and isolation were factors that
increased anxiety and stress, and led to new cases of alcohol
misuse and AUD. Our findings from this Phase 2 clinical
trial─ibudilast improved drinking outcomes and reduced the
rewarding response to alcohol in brains of individuals with AUD─are
timely and very encouraging for the treatment of AUD.”
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 16 million people in the U.S. have AUD and less
than 10% receive treatment for the disease. There is a high unmet
medical need for better treatments for AUD.
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 such as ALS (amyotrophic lateral
sclerosis), progressive MS (multiple sclerosis), and DCM
(degenerative cervical myelopathy); and for glioblastoma, CIPN
(chemotherapy-induced peripheral neuropathy), and substance use
disorder. In addition, MN-166 (ibudilast) is being 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, patients at risk
of developing acute respiratory distress syndrome (ARDS), and
substance dependence. MN-001 (tipelukast) is being 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'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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