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 Principal Investigator, Lara Ray, PhD,
Professor at the Department of Psychology, University of California
Los Angeles (UCLA) presented the results of the Ibudilast and
Alcohol Use Disorder Phase 2 trial at the American Psychological
Association 2020 Annual Convention held online.
The clinical trial is 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 is 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 heavy drinking days and
alcohol neural cue reactivity, and to test if neural activation to
alcohol cues, evaluated by functional magnetic resonance (fMRI)
neuroimaging, is predictive of drinking outcomes. A total of 52
alcohol use disorder (AUD) patients were enrolled in this
trial.
The highlights of Dr. Ray’s presentation are as follows:
- Drinking Outcomes: Ibudilast significantly reduced the number
of heavy drinking days compared to placebo (p=0.03)
- Alcohol Neural Cue Reactivity: There was a significant effect
of ibudilast on alcoholic beverage images (ALC) vs. non-alcoholic
beverage images (BEV) percent signal change in the bilateral
ventral striatum (VS) evaluated by fMRI (p=0.02)
- Ibudilast attenuated alcohol cue-elicited activation in the VS
relative to placebo
- Predicting Drinking by Medication: Significant interaction
between ibudilast and activation in the VS on subsequent drinking
(p=0.02)
- Patients treated with ibudilast and had attenuated VS
activation drank the least in the week after the scan
- Illustrates how neuroimaging (alcohol cue reactivity paradigm)
can help inform the neurobiological mechanism of action of a novel
pharmacotherapy
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer
of MediciNova, Inc. commented, “We are extremely pleased
with the positive results from the UCLA alcohol use disorder
Phase 2 trial conducted by Dr. Ray. This is the first study to show
the positive effect of MN-166 to attenuate activation in the brain
in a neuroimaging study. It is quite impressive that ibudilast
significantly reduced binge drinking after only 14 days of
treatment. According to Nielsen, alcohol sales in stores were up
54% in late March compared to a year ago, online sales were up
nearly 500% in late April compared to a year ago, and there has
been unprecedented demand for larger pack sizes of wine and
spirits. According to the American Heart Association, the COVID-19
pandemic brings new concerns about excessive drinking. We are
thrilled that MN-166 has demonstrated great potential to reduce the
increasing problem of alcohol use disorder.”
Professor Lara Ray commented, “We are very excited to report the
positive data from our Phase 2 clinical trial in AUD. Our first
clinical trial demonstrated that ibudilast significantly reduced
basal, daily alcohol craving in AUD patients. In the current study,
we found that ibudilast improved drinking outcomes and reduced the
rewarding response to alcohol in the brain of AUD patients, which
demonstrates its potential as a novel AUD pharmacotherapy.”
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
MN-166 (ibudilast) has been marketed
in Japan and Korea since 1989 to treat
post-stroke complications and bronchial asthma. MN-166 (ibudilast)
is a first-in-class, orally bioavailable, small molecule
phosphodiesterases (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 substance use disorders, neurodegenerative
diseases (e.g., ALS and progressive MS), and chronic neuropathic
pain. MediciNova is developing MN-166 for various neurological
conditions such as progressive MS, ALS and substance
abuse/addiction as well as prevention of acute respiratory distress
syndrome (ARDS) caused by COVID-19.
About MediciNova
MediciNova, Inc. is a publicly traded biopharmaceutical company
focused on developing novel therapeutics for the treatment of
diseases with high unmet medical needs with a primary commercial
focus on the U.S. market. MediciNova’s current strategy is to focus
on BC-PIV vaccine for COVID-19, MN-166 (ibudilast) for neurological
disorders such as progressive multiple sclerosis (MS), amyotrophic
lateral sclerosis (ALS), degenerative cervical myelopathy (DCM),
glioblastoma (GBM), and substance dependence (e.g., alcohol use
disorder, methamphetamine dependence, opioid dependence), as well
as prevention of acute respiratory distress syndrome (ARDS) caused
by COVID-19, 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) and MN-029 (denibulin). 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 BC-PIV vaccine, 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, 2019 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
President MediciNova,
Inc.
info@medicinova.com
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