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
initiate a biomarker study for evaluating MN-166 (ibudilast) in
methamphetamine (MA) use disorder.
The clinical trial is a collaborative effort between MediciNova,
Inc., Dr. William Hoffman, Associate Professor of Psychiatry and
Behavioral Neuroscience at Oregon Health & Science University
(OHSU), Staff Psychiatrist, Mental Health and Clinical
Neurosciences Division at the Portland VA Medical Center, and
Investigator in the Methamphetamine Abuse Research Center at OHSU,
and Dr. Aaron Janowsky, Professor of Psychiatry and Behavioral
Neuroscience, OHSU, Director, Methamphetamine Abuse Research
Center, and Research Career Scientist at the Portland VA Medical
Center in Portland, Oregon.
The proposed clinical trial will evaluate MN-166 (ibudilast) as
a potential treatment for individuals diagnosed with MA use
disorder with or without post-traumatic stress disorder (PTSD).
This study has already completed FDA review and will be initiated
by Dr. William Hoffman at Portland VA Medical Center and Oregon
Health & Science University.
Dr. Yuichi Iwaki, President and CEO of MediciNova, Inc.,
commented, “We are excited to collaborate with Dr. Hoffman and Dr.
Janowsky to explore the potential for MN-166 as a pharmacotherapy
for methamphetamine use disorder. There is a large unmet
medical need for patients with methamphetamine use disorder as
there are no pharmaceutical treatments approved for this
indication.”
Dr. William Hoffman, the Principal Investigator for this
project, commented, “We are pleased to partner with MediciNova to
evaluate MN-166 in the treatment of methamphetamine use disorder.
Methamphetamine induces neuroinflammation in animal models and in
humans, and recent studies have shown MN-166 to have positive
results in methamphetamine craving and favorable toxicology.”
About the Trial
This is a double-blind, randomized, single-center, outpatient
pilot study to evaluate MN-166’s (ibudilast) ability to decrease
neuroinflammation and alter brain function in recently abstinent MA
users (N=28). The study endpoints are 1) to determine the
relationship between positron emission tomography (PET) /magnetic
resonance spectroscopy (MRS) markers of neuroinflammation and
ventral striatal responses to reward as assessed by the Monetary
Incentive Delay Task (MID) with functional magnetic resonance
imaging (fMRI) and mesocorticolimbic resting-state functional
connectivity (RSFC) with resting-state fMRI; 2) to determine
whether a 4-week treatment of ibudilast reduces neuroinflammation
and alters brain function compared to placebo; and, 3) to determine
if changes in neuroinflammation track with changes in
mesocorticolimbic RSFC and in ventral striatal responses to reward.
Studies have shown that neuroinflammation plays a role in abnormal
brain function and MA induces neuroinflammation. Eligible subjects
will receive 50 mg of MN-166 (ibudilast) or placebo twice a day for
4 weeks, with a Week 1 visit to evaluate safety and study
medication adherence and a visit at Day 30 for assessments
including laboratory tests, safety/medication adherence, and
behavioral and cognitive questionnaires. Brain imaging
assessments will be conducted on Day 0 (baseline) and Day 30. This
study is supported by the U.S. Department of Veterans Affairs.
MediciNova plans to provide regulatory, scientific and analytical
support, as well as study drug and placebo supply.
About the Methamphetamine Abuse Research Center at OHSU
and the Portland VA Medical Center
The Methamphetamine Abuse Research Center (MARC) at OHSU and the
Portland VA Medical Center is a NIDA center that approaches drug
research at all levels including brain, body, cognition, and
genetics. These two institutions work in collaboration to advance
the treatment of illnesses, especially co-existing conditions such
as MA use disorder and PTSD in the military veteran
population.
About Methamphetamine Use Disorder
According to the Substance Abuse and Mental Health Services
Administration’s (SAMHSA) 2016 National Survey on Drug Use and
Health, there are approximately 684,000 people aged 12 or older
with methamphetamine use disorder (includes those with dependence
or abuse) in the U.S. According to the Rand Corporation, the
estimate of the economic burden in the U.S. of methamphetamine use,
based on the most recent year for which data are available, is
approximately $23.4 billion. Currently, there is no pharmaceutical
treatment approved for methamphetamine dependence. Among
veterans with substance use disorders, those with MA use disorder
have additional behavioral, health care utilization, and
psychiatric characteristics (US Department of Veterans Affairs
2017).
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/addiction. 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 commercial focus on the U.S. market. MediciNova's current
strategy is to focus on MN-166 (ibudilast) for neurological
disorders such as progressive MS, ALS and substance dependence
(e.g., alcohol use disorder, methamphetamine dependence and 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, 2016 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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