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 positive
top-line results from MediciNova’s clinical trial of MN-166
(ibudilast) in amyotrophic lateral sclerosis (ALS). Data
analysis was conducted on the 51 subjects without non-invasive
ventilation in the ITT (Intent To Treat) population. The trial
achieved the primary endpoint of safety and tolerability, and also
demonstrated efficacy trends in favor of MN-166 (ibudilast).
MN-166 (ibudilast) demonstrated a favorable safety and
tolerability profile. All subjects in the study received 100
mg of riluzole per day. There were 7 serious adverse events
(SAEs) reported during the study but none of the SAEs were related
to the study drug. All treatment-related adverse events
(TRAEs) were mild to moderate in intensity and no severe or
life-threatening TRAEs were reported. The most frequently reported
TRAEs were nausea, anorexia, and loss of appetite, which were
expected and are common side effects of both riluzole treatment and
MN-166 (ibudilast) treatment.
There was a higher rate of responders on the ALSFRS-R total
score in the MN-166 (ibudilast) group compared to the placebo
group. The Amyotrophic Lateral Sclerosis Functional Rating
Scale-Revised (ALSFRS-R) total score measures the functional
activity of an ALS subject. ALS subjects decline on the
ALSFRS-R total score over time as the disease progresses and their
symptoms worsen. A responder was defined as a subject that
improved on the ALSFRS-R total score, had no change on the score,
or the score declined by 1 point. If a subject’s ALSFRS-R
total score declined by 2 points or more, they were considered a
non-responder. During the six-month, double-blind portion of
the study, 29.4% of subjects in the MN-166 (ibudilast) group were
responders compared to 17.6% of subjects in the placebo
group. For the subjects who were treated with placebo during
the six-month, double-blind portion of the study and then switched
to MN-166 (ibudilast) treatment during the six-month open-label
extension, 35.3% of subjects were responders when taking MN-166
(ibudilast).
There was a higher rate of responders on the ALSAQ-5 score in
the MN-166 (ibudilast) group compared to the placebo group.
The Amyotrophic Lateral Sclerosis Assessment Questionnaire
(ALSAQ-5) score measures the physical mobility, activities of daily
living and independence, eating and drinking, communication, and
emotional functioning. A responder was defined as a subject
that improved on the ALSAQ-5 score or had no change on the
score. If a subject’s ALSAQ-5 score worsened, they were
considered a non-responder. During the six-month,
double-blind portion of the study, 50.0% of subjects in the MN-166
(ibudilast) group were responders compared to 23.5% of subjects in
the placebo group. For the subjects who were treated with
placebo during the six-month, double-blind portion of the study and
then switched to MN-166 (ibudilast) treatment during the six-month
open-label extension, 29.4% of subjects were responders when taking
MN-166 (ibudilast). Overall, 43.1% of subjects treated with
MN-166 (ibudilast) for six months were responders, and this was
significantly higher than the 23.5% of placebo-treated subjects who
were responders (p=0.046).
This was the first study of MN-166 (ibudilast) in ALS and the
study provides the necessary clinical data for powering assumptions
for the next study of MN-166 (ibudilast) in ALS.
The top-line results will be presented as an oral presentation
at the 28th International Symposium on ALS/MND (amyotrophic lateral
sclerosis/motor neurone disease) at the Westin Boston Waterfront in
Boston, MA, USA on Friday, December 8, 2017 at 4:00 P.M., Eastern
Time. The presentation entitled "Ibudilast: Bi-modal
therapy with riluzole in early and advanced ALS patients"
will be given by principal investigator Dr. Benjamin Rix Brooks,
Director, Carolinas Neuromuscular/ALS-MDA Center at Carolinas
HealthCare System Neurosciences Institute.
Dr. Benjamin Rix Brooks, principal investigator, commented, “The
results of this study are very encouraging and indicate that MN-166
has the potential to stop disease progression and improve
functional activity in some ALS patients. This is an
impressive effect that has not been observed in studies of other
drugs for ALS. We are excited to participate in the further
development of MN-166 for this devastating disease.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are very pleased with the top-line
data as this study achieved both goals we set out to achieve: (1)
MN-166 was safe and well tolerated in ALS, and (2) MN-166
demonstrated efficacy trends that warrants further investigation in
a larger ALS study. We look forward to the results from the
second study of MN-166 in ALS, which is ongoing at Massachusetts
General Hospital and is using a higher dose of 100 mg of MN-166 per
day.”
About the 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 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).
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 6,000 people in the U.S.
are diagnosed with ALS each year.
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, 2016 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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