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 additional
data from the completed SPRINT-MS Phase 2b trial of MN-166
(ibudilast) in progressive multiple sclerosis (MS) will be
presented in three separate presentations at the American
Academy of Neurology (AAN) 71st Annual Meeting to be held May 4-10,
2019 in Philadelphia, Pennsylvania.
Presentation details:
1) "Response to Treatment According to Progressive
Disease Type: Analysis from a Phase II Progressive MS Trial of
Ibudilast" will be presented by Dr. Andrew Goodman,
Professor of Neurology and Neuroimmunology at the University of
Rochester School of Medicine and Dentistry and an investigator of
the SPRINT-MS trial. In this presentation, Dr. Goodman will present
results of the post-hoc analysis from the SPRINT-MS Phase 2b trial
evaluating the effect of MN-166 (ibudilast) on progression of brain
atrophy in subjects with primary and secondary progressive
MS.Session Date and Time: Monday, May 6, 2019 at 2:06 PM
ET.Session: Platform Presentation 007: Session S12
Progressive Multiple Sclerosis
2) "Effect of Ibudilast on Neurofilament-light Chain in
Progressive MS: Analysis from a Phase II Trial" will be
presented by Dr. Robert Fox, Principal Investigator of the
SPRINT-MS Phase 2b trial and Vice-Chair for research in the
Neurological Institute’s Mellen Center for Multiple Sclerosis at
Cleveland Clinic. In this presentation, Dr. Fox will present data
on the effect of MN-166 (ibudilast) on serum and cerebrospinal
fluid neurofilament-light from the SPRINT-MS Phase 2b trial in
subjects with primary and secondary progressive MS.
Session Date and Time: Tuesday, May 7, 2019 at 11:30 AM - 6:30
PM ET.
Session: Poster Session 3: MS Clinical Trials and
Therapeutic Research
3) "Effect of ibudilast on macular measures in
progressive MS: OCT analysis from a phase II trial" will
be presented by Dr. Robert Bermel, Staff Neurologist in the
Neurological Institute’s Mellen Center for Multiple Sclerosis at
Cleveland Clinic. In this presentation, Dr. Bermel will present
data from the SPRINT-MS Phase 2b trial evaluating the effect of
MN-166 (ibudilast) on reducing macular volume loss and ganglion
cell/inner plexiform layer (GCIP) thinning in subjects with primary
and secondary progressive MS.
Session Date and Time: Tuesday, May 7, 2019 at 11:30 AM - 6:30
PM ET.
Session: Poster Session 3: MS Clinical Trials and
Therapeutic Research
All presentations will take place at the AAN meeting site,
Pennsylvania Convention Center, 1101 Arch Street, Philadelphia, PA
19107
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. 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
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) is a first-in-class, orally bioavailable,
small molecule macrophage migration inhibitory factor (MIF)
inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that
suppresses pro-inflammatory cytokines and promotes neurotrophic
factors. It attenuates activated glial cells, which play a major
role in certain neurological conditions. MN-166 (ibudilast)'s
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical studies, which provide the
rationale for treatment of progressive multiple sclerosis (MS) and
other neurological diseases such as amyotrophic lateral sclerosis
(ALS), glioblastoma (GBM), and substance abuse/addiction.
MediciNova is developing MN-166 for progressive MS and other
neurological conditions such as ALS, glioblastoma, substance
abuse/addiction, and chemotherapy-induced neuropathy. MediciNova
has a portfolio of patents which covers 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 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 multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), 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) and MN-029 (denibulin). 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, 2018 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 CONTACTGeoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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