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 the presentation
of results from a completed Phase 1b trial of MN-166 (ibudilast) in
methamphetamine dependence at a symposium titled “Neuroimmune
Modulation in Addiction: Preclinical and Clinical Findings” at the
50th Winter Conference on Brain Research held from January 28 to
February 2, 2017 in Big Sky, Montana.
Keith Heinzerling, M.D., M.P.H., Associate
Professor, Department of Family Medicine and Medical Director of
the UCLA Center for Behavioral and Addiction Medicine, and Marisa
Briones, Ph.D., Postdoctoral Research Fellow, presented results for
the completed Phase 1b trial which evaluated MN-166 (ibudilast) in
patients with methamphetamine dependence.
Major highlights from the presentation, “Clinical
Development of Ibudilast for Methamphetamine Use Disorder,” include
the following:
- Ibudilast increased levels of the biomarker brain-derived
neurotrophic factor (BDNF), a growth factor which helps to support
the survival of existing neurons and encourages the growth of new
neurons and synapses, when compared to placebo;
- Ibudilast decreased levels of the biomarker tumor necrosis
factor (TNFα), a pro-inflammatory cytokine, when compared to
placebo (p=0.027);
- Ibudilast decreased levels of the biomarker vascular cell
adhesion molecule (VCAM1), which mediates leukocyte-endothelial
cell adhesion and signal transduction and may play a role in the
development of neurodegenerative disorders, when compared to
placebo (p=0.035);
- Ibudilast was safe and well tolerated during the
methamphetamine infusions;
- Ibudilast is currently being investigated in a Phase 2 study to
determine its ability to help methamphetamine users reduce or stop
use altogether.
Yuichi Iwaki, MD, PhD, President and Chief
Executive Officer of MediciNova, Inc., commented, "We are very
pleased with ibudilast’s encouraging results reported in this
study, specifically the data which demonstrates ibudilast’s
neuroprotective and anti-neuroinflammatory effects in
methamphetamine-dependent subjects. Moreover, these results
validate MN-166’s neuroprotective and anti-inflammatory properties
by evaluation of biomarkers for the first time in a clinical
trial. Based on these findings, along with the positive
safety and tolerability results, we look forward to advancing our
program to further evaluate ibudilast’s potential utility in the
treatment of methamphetamine dependence. Congratulations to the
UCLA researchers on their unwavering efforts to evaluate MN-166 for
this devastating disorder.”
About the Methamphetamine Dependence
Clinical Trial
This study was a randomized, double-blind,
placebo-controlled within-subject Phase 1b study of MN-166
(ibudilast) in methamphetamine-dependent, non-treatment seeking
abusers. The study duration was approximately 6 weeks per
subject. Participants were randomized to one of 2 medication
sequences: 1) placebo - 20 mg ibudilast – 50 mg ibudilast twice/day
or 2) 20 mg ibudilast - 50 mg ibudilast - placebo twice/day.
Methamphetamine infusions (0 mg, 15 mg, 30 mg) were given while
subjects were taking ibudilast or placebo and were followed by
cardiovascular assessments, subjective effects ratings, and
pharmacokinetic (PK) assessments.
The ongoing methamphetamine dependence study is a
randomized, placebo-controlled, double-blind, outpatient Phase 2
study of MN-166 (ibudilast) which will enroll up to 140
treatment-seeking methamphetamine dependent subjects.
Eligible participants are randomized, stratified by HIV serostatus,
to ibudilast 50 mg twice a day or placebo treatment for 12 weeks,
with twice weekly clinic visits for counseling, urine drug tests,
and safety/medication adherence monitoring. The study
is designed to detect a statistically significant benefit of MN-166
over placebo on the primary study outcome of methamphetamine
abstinence during the final two weeks of treatment.
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 progressive MS and
other neurological conditions such as ALS and drug use disorders.
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 neurodegenerative
diseases (e.g., progressive MS and amyotrophic lateral sclerosis
(ALS), also known as Lou Gehrig’s disease), substance
abuse/addiction and chronic neuropathic pain.
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., 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, 2015 and its subsequent periodic reports on
Forms 10-Q and 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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