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
analyses of MediciNova’s completed clinical trial of MN-166
(ibudilast) in ALS (amyotrophic lateral sclerosis), which was
conducted at Carolinas HealthCare System’s Neuromuscular/ALS-MDA
Center at Carolinas HealthCare System Neurosciences Institute,
will be presented on December 5, 2019 at 10:30 am local time at the
30th International Symposium on ALS/MND (amyotrophic lateral
sclerosis/motor neurone disease) in Perth, Australia.
Highlights of the presentation, entitled "Interaction
(nonuniformity) of ALS Progression and the Efficacy of MN‑166
(ibudilast)”, which will be presented by Kazuko Matsuda,
M.D. Ph.D. M.P.H., Chief Medical Officer of MediciNova, Inc.,
include the following:
- We evaluated the potential background factors of patients’
characteristics that could reasonably predict both ALS disease
progression and treatment efficacy. These factors included
gender, age, race, site of onset (upper limb, lower limb, bulbar
onset), UMN (upper motor neuron) / LMN (lower motor neuron) symptom
involvement, and ALS history (i.e. days from first onset of symptom
to trial enrollment).
- Regression Tree Analysis and Stepwise Regression Analysis were
performed to determine which potential factors have an impact on
the treatment effect of MN-166 as assessed by the ALSFRS-R
score.
- The regression analyses determined that ALS history was a
statistically significant factor affecting treatment effect
(p=0.015).
- Correlational Analysis was conducted to analyze the correlation
between (1) ALS history and baseline ALSFRS-R score, and (2) ALS
history and disease progression, measured as change in ALSFRS-R
score from baseline to end of treatment.
- A significant negative correlation (-0.72, p<0.01) was
observed between ALS history and baseline ALSFRS-R scores in
patients with ALS onset <600 days prior to enrollment (i.e.
short ALS history), but not in patients with ALS onset >600 days
prior to enrollment (i.e. long ALS history).
- A significant positive correlation (0.63, p<0.05) was
observed between ALS history and ALS disease progression in the
placebo group. With riluzole treatment only (without MN-166
treatment), greater disease progression was observed in short ALS
history patients.
- No correlation was observed between ALS history and ALS disease
progression in the MN-166 group, which was attributed to the
treatment effect in short ALS history patients.
- The results of these analyses indicate that the efficacy of
MN-166 is expected to be more robust in patients with a short ALS
history.
Yuichi Iwaki, M.D. Ph.D., President and Chief Executive Officer
of MediciNova, Inc., commented, “We are very pleased to present
these additional analyses from the completed ALS trial. The
conclusions from this work and our other analyses completed
previously have already been incorporated into the design of our
Phase 3 trial. We believe our improved study design, which
includes only ALS subjects with symptom onset of less than 18
months, gives this trial a much higher probability of success.”
About the Phase 2 ALS Trial
MediciNova, in collaboration with Dr. Benjamin Rix Brooks,
Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas
HealthCare System Neurosciences Institute, evaluated 60 mg of
MN-166 (ibudilast) per day in both early and advanced stage ALS
patients. All subjects in the study received 100 mg of riluzole per
day. This trial was a randomized, double-blind, placebo-controlled
study which included a six-month treatment period followed by a
six-month open-label extension. The primary endpoint was safety and
tolerability and the study also evaluated several efficacy
endpoints including functional activity (ALSFRS-R). Data analyzed
from the 51 early ALS subjects (the intent-to-treat/ITT population)
was presented at the 29th International Symposium on ALS/MND in
Glasgow, Scotland, UK in December 2018. There was a higher
percentage of responders on the ALSFRS-R total score, MMT (manual
muscle testing) and ALSAQ-5 score (subjective quality-of-life
questionnaire) in the MN-166 (ibudilast) group compared to the
placebo group. This was the first study of MN-166 (ibudilast) in
ALS and the study provides the necessary clinical data for powering
assumptions for the Phase 3 trial of MN-166 (ibudilast) in ALS.
About ALS
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's
disease, is a progressive neurodegenerative disease that affects
nerve cells in the brain and the spinal cord. The nerves lose the
ability to trigger specific muscles, which causes the muscles to
become weak. As a result, ALS affects voluntary movement and
patients in the later stages of the disease may become completely
paralyzed. Life expectancy of an ALS patient is usually 2-5 years.
According to the ALS Association, there are approximately 20,000
ALS patients in the U.S. and approximately 5,000 people in the U.S.
are diagnosed with ALS each year.
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 amyotrophic lateral sclerosis (ALS),
progressive multiple sclerosis (MS) and other neurological diseases
such as glioblastoma (GBM), and substance abuse/addiction.
MediciNova is developing MN-166 for ALS, progressive MS and other
neurological conditions such as degenerative cervical myelopathy
(DCM), glioblastoma, substance abuse/addiction, and
chemotherapy-induced peripheral neuropathy. MediciNova has a
portfolio of patents which covers the use of MN-166 (ibudilast) to
treat various diseases including ALS, progressive MS, 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), degenerative cervical myelopathy (DCM), 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 CONTACT:Geoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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