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 it plans
to initiate a clinical trial of MN-166 (ibudilast) in alcohol
dependence and withdrawal in collaboration with researchers at the
University of California, Los Angeles (UCLA).
The clinical trial is a collaborative effort between MediciNova,
Inc., and Dr. Lara Ray, Professor, Department of Psychology and
Department of Psychiatry and Biobehavioral Sciences, Brain Research
Institute at the University of California, Los Angeles and is
funded by the Center for Study of Opioid Receptors and Drugs of
Abuse (CSORDA; National Institute on Drug Abuse Grant
P50-DA005010). The proposed clinical trial will evaluate MN-166
(ibudilast) as a potential treatment for individuals diagnosed with
alcohol use disorder (AUD), and test whether MN-166 is more
effective for those patients who experience withdrawal-related
dysphoria than those who do not experience withdrawal. Previous
findings showed that MN-166 was effective in blunting alcohol
reward among participants with greater depressive symptoms, a
hallmark symptom of prolonged alcohol withdrawal.
Lara Ray, PhD, Principal Investigator of the study, commented,
“We are pleased to collaborate with MediciNova to continue our
evaluation of MN-166 in the treatment of alcohol use disorder. The
interplay between affect, withdrawal, and response to MN-166 in
this population is an intriguing one.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are excited to collaborate with
Dr. Ray again to explore further the effects of MN-166 as a
pharmacotherapy in AUD. We appreciate the continued grant
support for this program by the NIH."
About the Clinical Trial:
This randomized, double-blind, placebo-controlled, outpatient
study plans to enroll 50 non-treatment seeking individuals with
moderate-to-severe AUD. Participants will be stratified based on
presence or absence of withdrawal-related dysphoria and will be
randomly assigned to a 14-day treatment period involving repeat
oral administration of either MN-166 escalated up to 100 mg/day or
placebo. Ecological Momentary Assessment (EMA), a research method
which allows for the examination of dynamic processes associated
with depression and depression-related phenomena, will be done on a
daily basis. During the treatment period, participants will take
the study medication and will report on their alcohol craving as
well as mood surveys and standard safety tests. The key study
outcomes include whether MN-166 reduces basal level negative affect
during abstinence, and in doing so, will interfere with
alcohol-induced blunting of negative affectivity as captured during
naturalistic drinking episodes. This study will also test whether
the clinically beneficial effects of MN-166 are greater in the
group with withdrawal-related dysphoria than the non-withdrawal
group.
About Alcohol Use Disorder
Alcohol use disorder (AUD) is a prevalent and disabling
psychiatric disorder with limited treatment options. 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) has
been marketed in Japan and Korea since 1989 to treat post-stroke
complications and bronchial asthma. MediciNova is developing
MN-166 for various neurological conditions such as progressive MS,
ALS and substance abuse disorder. MN-166 (ibudilast) is a
first-in-class, orally bioavailable, small molecule
phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage
migration inhibitory factor (MIF) inhibitor that suppresses
pro-inflammatory cytokines and promotes neurotrophic factors. It
attenuates activated glia cells, which play a major role in certain
neurological conditions. Ibudilast's anti-neuroinflammatory and
neuroprotective actions have been demonstrated in preclinical and
clinical study results and provide the rationale for its
therapeutic utility in drug use disorders, neurodegenerative
diseases (e.g., ALS and progressive MS), substance abuse/addiction
and chronic neuropathic pain. MediciNova has a portfolio of
patents which cover the use of MN-166 (ibudilast) to treat various
diseases including drug use disorders, ALS, and progressive MS.
MN-166 (ibudilast) was granted Fast-Track Designation for the
treatment of methamphetamine dependence by the U.S. Food and Drug
Administration.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company
founded upon acquiring and developing novel, small-molecule
therapeutics for the treatment of diseases with unmet medical needs
with a primary commercial focus on the U.S. market. MediciNova's
current strategy is to focus on MN-166 (ibudilast) for neurological
disorders such as progressive multiple sclerosis (MS), amyotrophic
lateral sclerosis (ALS) and substance dependence (e.g., alcohol use
disorder, methamphetamine dependence, opioid dependence) and MN-001
(tipelukast) for fibrotic diseases such as nonalcoholic
steatohepatitis (NASH) and idiopathic pulmonary fibrosis
(IPF). MediciNova’s pipeline also includes MN-221
(bedoradrine) for the treatment of acute exacerbations of asthma
and MN-029 (denibulin) for solid tumor cancers. MediciNova is
engaged in strategic partnering and other potential funding
discussions to support further development of its programs. For
more information on MediciNova, Inc., please visit
www.medicinova.com.
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-221, MN-001, 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-221, MN-001, 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, 2017 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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