MediciNova Announces the Completion of Enrollment in the Phase 2 Clinical Trial of MN-166 (ibudilast) in Methamphetamine Depe...
September 19 2017 - 06:00AM
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 the Phase
2 clinical trial of MN-166 (ibudilast) in methamphetamine
dependence has completed enrollment.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are pleased that enrollment is now
completed in the first study to evaluate MN-166’s (ibudilast)
potential clinical utility for methamphetamine dependence. We
look forward to the final results of the study which we expect by
the first quarter of 2018."
About the Clinical Trial: This study was a
randomized, double-blind, placebo-controlled, outpatient Phase 2
study of MN-166 (ibudilast) in treatment-seeking individuals with
methamphetamine dependence, stratified by HIV serostatus, at a UCLA
research clinic. Eligible participants were randomly assigned to
MN-166 (ibudilast) 100 mg/day or placebo treatment for 12 weeks,
with twice-weekly clinic visits for counseling, urine drug tests,
and safety/medication adherence monitoring. The study was designed
to detect a statistically significant benefit of MN-166 (ibudilast)
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 licensed MN-166
(ibudilast) from Kyorin Pharmaceutical Co., Ltd. for potential
utility in RRMS. Intellectual property was additionally established
or obtained by MediciNova in progressive MS and other neurological
conditions. 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 on acquiring and developing novel, small-molecule
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 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-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, 2016 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'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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