MediciNova Announces Initiation of Interim Efficacy Analysis in Phase 2b Trial of MN-166 (ibudilast) in Progressive MS
13 July 2016 - 8:30PM
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 50% of
patients (127 out of 255 enrolled patients) have completed the
96-week treatment period in the ongoing Phase 2b clinical trial of
MN-166 (ibudilast) in progressive multiple sclerosis (progressive
MS). The trial’s external Data Safety Monitoring Board will review
the results of an interim efficacy analysis in the fourth quarter
of 2016. The purpose of the analysis will be to make
recommendations to the National Institute of Neurological Diseases
and Stroke (NINDS) regarding the trial.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc. commented, "We are very pleased to have reached
the 50% completion milestone in this important study. The unmet
medical need for progressive MS patients is extremely high as there
is no treatment approved for long-term use for these patients. We
look forward to providing further updates as we receive results of
the interim analysis."
About the Progressive MS Trial
The Phase 2 Secondary and Primary Progressive Ibudilast
NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) involves 28
enrolling clinical sites across the U.S. and is designed to
evaluate the safety, tolerability and efficacy of MN-166
(ibudilast) administered twice daily to subjects with primary or
secondary progressive multiple sclerosis (PPMS or SPMS,
respectively). 255 qualifying subjects were randomly assigned
1:1 to inactive control (placebo) or MN-166 (ibudilast)
administered at a dose of up to 100 mg/day (50 mg twice daily). The
progressive MS subjects may be either untreated with long-term
disease modifying therapy (DMT) or may continue either glatiramer
acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b) treatment.
Hence, randomization was controlled (stratified) by two factors:
therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs.
SPMS). The primary objectives of the study are to 1) evaluate the
activity of ibudilast (MN-166) versus placebo at 96 weeks as
measured by quantitative magnetic resonance imaging (MRI) analysis
for whole brain atrophy using brain parenchymal fraction (BPF) and
2) evaluate the safety and tolerability of ibudilast (MN-166)
versus placebo administered orally in subjects with PPMS or SPMS.
Secondary measures include disability, imaging analyses of brain
and retinal tissue integrity, cortical atrophy, cognitive
impairment, quality-of-life and neuropathic pain. Exploratory
objectives include pharmacokinetic and biomarker analyses.
About the Cooperative Effort
The collaborating entities include NeuroNEXT, the Cleveland
Clinic, the National MS Society and MediciNova. NINDS's Network for
Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was
created to conduct studies of treatments for neurological diseases
through partnerships with academia, private foundations and
industry. NeuroNEXT sites include many of the leading medical
centers in the U.S. The goals of NeuroNEXT include testing of
promising neurological therapies in Phase 2 clinical trials,
optimizing drug development time and cost components through an
established clinical trials infrastructure, and the coordination of
public/private sector efforts by leveraging NINDS’s existing
relationships with academic investigators and patient advocacy
groups. A clinical coordinating center for the network is based at
Massachusetts General Hospital and the data coordinating center is
at University of Iowa. Principal Investigator Dr. Robert Fox and
colleagues at the Cleveland Clinic collaborate with
co-investigators at academic medical centers in the NeuroNEXT
network. The National MS Society is providing patient advocate
input and trial enrollment awareness. MediciNova holds the trial
IND with the FDA Division of Neurology Products and provides
scientific and analytical support, as well as drug and placebo
supply.
About Progressive Multiple Sclerosis
According to the National MS Society, MS affects approximately
2.3 million people worldwide. Approximately 85% of MS patients are
initially diagnosed with relapsing remitting MS (RRMS). Most RRMS
patients will eventually transition into SPMS in which there are
fewer or no relapses but gradual worsening of health. Approximately
10% of MS patients are diagnosed with PPMS at onset and exhibit
increasing disabilities in walking, vision, mental acuity, and
other bodily functions that are typical in both PPMS and SPMS
without ever experiencing relapses or remissions. Current therapies
for MS affect the inflammatory response, but provide limited
benefit for neurodegeneration and/or brain tissue repair. There is
an unmet medical need for agents that may provide
neuroprotection.
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
for potential utility in relapse-remitting multiple sclerosis
(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 glial 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.
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, 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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