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 the
presentation of additional positive top-line results from the
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.
The top-line results from the SPRINT-MS Phase 2b Trial of MN-166
(ibudilast) in progressive MS were presented by Dr. Robert Fox,
Staff Neurologist at the Cleveland Clinic and the principal
investigator of this clinical trial, as a late-breaking oral
platform presentation, on Saturday, October 28, 2017 at the 7th
Joint ECTRIMS* – ACTRIMS** Meeting in Paris, France. The top-line
results include the following:
Primary Endpoint #1: MN-166 (ibudilast) demonstrated a
statistically significant 48% reduction in the rate of progression
of whole brain atrophy compared to placebo (p=0.04) as measured by
MRI analysis using brain parenchymal fraction (BPF).
Primary Endpoint #2: MN-166 (ibudilast) demonstrated a
favorable safety and tolerability profile. There was not an
increased rate of serious adverse events in the MN-166 (ibudilast)
group compared to the placebo group. There were no
opportunistic infections, no cancers, no cardiovascular events
(i.e. no heart attacks or strokes), and no deaths related to MN-166
(ibudilast) treatment, as determined by an Independent Medical
Monitor. There was no statistically significant difference in
tolerability between the MN-166 (ibudilast) group and the placebo
group. The most common treatment-emergent adverse events
during the study were gastrointestinal adverse events, which
occurred with a higher frequency in the MN-166 (ibudilast) group,
and upper respiratory tract infections, which occurred with a
higher frequency in the placebo group.
Analysis of additional endpoints, including clinical endpoints,
is currently ongoing and is being conducted by the NeuroNEXT
network. The study was conducted by the NeuroNEXT network
with funding from the NIH National Institute of Neurological
Diseases and Stroke (NINDS), the National Multiple Sclerosis
Society, and MediciNova, Inc.
Dr. Robert Fox commented, “Ibudilast demonstrated a robust
reduction in the rate of progression of whole brain atrophy, which
is considered an important Phase 2 outcome measure in progressive
MS. In addition, ibudilast appears to have a favorable safety and
tolerability profile, which is just as important in developing
therapies for progressive MS.” Yuichi Iwaki, MD, PhD,
President and Chief Executive Officer of MediciNova, Inc.
commented, “We are thrilled with these results as ibudilast’s
effect on brain atrophy was even better than we expected.
This is very encouraging because brain atrophy is correlated with
disability progression. As soon as NeuroNEXT completes the
data analysis, we plan to get feedback from FDA so we can move this
program forward as fast as possible.”
* ECTRIMS (European Committee for Treatment and Research in
Multiple Sclerosis)
**ACTRIMS (Americas Committee for Treatment and Research in
Multiple Sclerosis)
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 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 in subjects with PPMS or SPMS. Additional
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. (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 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, 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