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 an
abstract regarding the completed SPRINT-MS Phase 2b Trial of MN-166
(ibudilast) in progressive multiple sclerosis (progressive MS),
which was conducted through the National Institutes of Health
(NIH)-sponsored NeuroNEXT network, has been selected for plenary
presentation at the American Academy of Neurology (AAN) 70th Annual
Meeting to be held April 21-27, 2018 in Los Angeles,
California.
The presentation entitled "A Phase II Trial of
Ibudilast in Progressive Multiple Sclerosis" will be presented by
Dr. Robert Fox, Staff Neurologist at the Cleveland Clinic and the
principal investigator of this clinical trial.
Presentation details are as
follows:
Date and Time: Tuesday, April 24, 2018, 9:15
am - 11:30 am
Session: Clinical Trials Plenary Session
Location: Los Angeles Convention Center, 1201
South Figueroa Street, Los Angeles, CA 90015
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 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. (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
collaborate 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 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
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 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 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., 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, 2017 and its subsequent periodic reports on Form
10-Q and current reports on Form 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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