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 New
England Journal of Medicine has published results of the SPRINT-MS
Phase 2b trial of MN-166 (ibudilast) in progressive multiple
sclerosis (progressive MS).
“These findings are significant for patients with progressive
MS,” says Robert Fox, M.D., the study’s principal investigator and
vice-chair for research in Cleveland Clinic’s Neurological
Institute. “Our hope is that the benefit of ibudilast in slowing
brain shrinkage will also translate to decreased progression of
associated physical disabilities in a future Phase 3 trial.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc. commented, “We are very pleased that results of
this important study were published in the New England Journal of
Medicine. We thank the NIH, the investigators, and the
National Multiple Sclerosis Society. We look forward to
moving on to Phase 3 and we are currently preparing for the
end-of-Phase 2 meeting with FDA. With a convenient oral
administration, a very favorable safety and tolerability profile,
and the potential for better efficacy than other drugs for
progressive MS, we believe ibudilast could become the
best-in-disease drug.”
About the Progressive MS Trial
The Phase 2b Secondary and Primary Progressive Ibudilast
NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) included 28
enrolling clinical sites across the U.S. and was designed to
evaluate the safety, tolerability and activity of MN-166
(ibudilast) administered orally twice daily to subjects with
primary progressive 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 were either untreated with
long-term disease modifying therapy (DMT) or continued on 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 were 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 in subjects with PPMS or SPMS. Additional
measures included disability, imaging analyses of brain and retinal
tissue integrity, cortical atrophy, cognitive impairment,
quality-of-life and neuropathic pain. Exploratory objectives
included pharmacokinetic and biomarker analyses.
About the Cooperative Effort
The collaborating entities included NeuroNEXT, the Cleveland
Clinic, the National MS Society and MediciNova. The Network
for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was
created by the National Institute of Neurological Disorders and
Stroke (NINDS), part of the National Institutes of Health, to
conduct studies of treatments for neurological diseases through
partnerships with academia, private foundations and industry.
NeuroNEXT sites are based at leading medical centers in the U.S.
(www.neuronext.org). 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 NeuroNEXT is led by Dr.
Merit Cudkowicz and is based at Massachusetts General Hospital and
the data coordinating center is led by Dr. Chris Coffey at the
University of Iowa. Principal Investigator Dr. Robert Fox and
colleagues at the Cleveland Clinic collaborated with
co-investigators at academic medical centers in the NeuroNEXT
network. The National MS Society provided patient advocate input,
trial enrollment awareness, and additional funding. MediciNova
holds the trial IND with the FDA’s Division of Neurology Products
and provided 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 neurologic function.
Approximately 15% of MS patients are diagnosed with PPMS at onset
and exhibit gradually increasing disability in walking, vision,
mental acuity, and other bodily functions without experiencing
relapses or remissions. Current therapies for MS affect the
inflammatory response, but provide limited benefit for the
neurodegeneration seen in progressive MS. There is a significant
unmet medical need for agents that may provide neuroprotection in
progressive MS.
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 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 upon acquiring and developing novel, small-molecule
therapeutics for the treatment of diseases with 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, 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'Brien
Vice President
MediciNova, Inc.
info@medicinova.com
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