MediciNova Announces Results of Phase 2 Clinical Trial of MN-166 (ibudilast) in Methamphetamine Dependence
March 29 2018 - 5:30AM
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, which was recently completed by investigators at UCLA,
did not meet the primary endpoint of methamphetamine abstinence
confirmed via urine drug screens during the final two weeks of
treatment (weeks 11 and 12). MN-166 (ibudilast) demonstrated
a favorable safety and tolerability profile. There was not an
increased rate of serious or severe adverse events in the MN-166
(ibudilast) group compared to the placebo group. There were
no infections, no cancers, no cardiovascular events (i.e. no heart
attacks or strokes), and no deaths related to MN-166 (ibudilast)
treatment. The most common treatment-related adverse events
during the study were gastrointestinal adverse events, which
occurred with a higher frequency in the MN-166 (ibudilast) group.
Dr. Keith Heinzerling, MD, principal investigator of this study,
commented, “It is disappointing that the study could not achieve
the primary endpoint with this study design and setting.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented “We will conduct further analyses of
the data with UCLA researchers, which will help us to better
understand how to optimize study design and setting for any future
clinical trials in substance dependence. We will discuss the
results with NIH/NIDA who provided the funding for this trial, the
opioid dependence trials and the alcohol dependence trial. We
plan to meet with FDA after we have data from the ongoing study of
MN-166 in methamphetamine use disorder at Oregon Health &
Science University.”
About the Methamphetamine Dependence 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 is developing MN-166 for progressive multiple sclerosis
(MS) and other neurological conditions such as 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 neurodegenerative
diseases (e.g., progressive MS and ALS), 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 progressive MS, ALS, and drug addiction.
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., opioid dependence, methamphetamine 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, 2017 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
Medicinova (NASDAQ:MNOV)
Historical Stock Chart
From Apr 2024 to May 2024
Medicinova (NASDAQ:MNOV)
Historical Stock Chart
From May 2023 to May 2024