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), announced that principal
investigator Dr. Benjamin Rix Brooks, Director, Carolinas
HealthCare System’s Neuromuscular/ALS-MDA Center at Carolinas
HealthCare System Neurosciences Institute, will present
additional clinical data from MediciNova’s completed clinical trial
of MN-166 (ibudilast) in ALS (amyotrophic lateral sclerosis)
tomorrow at the American Academy of Neurology (AAN) 70th Annual
Meeting in Los Angeles, California.
Highlights of the presentation entitled "Ibudilast –
Phosphodiesterase Type 4 Inhibitor – Bi-Modal Therapy with Riluzole
in Early [Not Requiring Non-Invasive Ventilation (NIV)] Cohort (EC)
and Advanced [Requiring NIV] (ANC) Amyotrophic Lateral Sclerosis
(ALS) Patients - Single-Center Adaptive Design Six-Month
Double-Blind (DB) - Placebo-Controlled Phase 1b/2a Epoch Followed
by Six-Month Open Label Extension (OLE) Epoch, Washout (WO) and
Post-Washout Epoch (PWO) - Final Report and Future Directions"
include the following:
- A responder was defined as a subject who achieved the composite
endpoint of (1) less than 12 unit decline in ALSFRS-R total score
at the end of the open-label extension period (i.e. average of less
than one unit decline per month over entire 12 month period),
and/or (2) less than one MMT unit decline in neck and/or leg
muscles at the end of the open-label extension period.
- There was a higher rate of responders in the MN-166 (ibudilast)
group compared to the placebo group. 32.4% (11/34) of
subjects in the MN-166 (ibudilast) group were responders compared
to 11.8% (2/17) of subjects in the placebo group (p=0.11).
- Responders showed improved survival (p=0.0010) in the 30 months
post MN-166 (ibudilast) treatment.
- Subjects who completed 6 months or 12 months MN-166 (ibudilast)
treatment per protocol showed improved survival (p=0.0025) in the
30 months post MN-166 (ibudilast) treatment.
The Amyotrophic Lateral Sclerosis Functional Rating
Scale-Revised (ALSFRS-R) total score, which ranges from 0 to 48,
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. Manual muscle
testing (MMT), which is graded on a scale from 0 to 5, measures the
muscle strength of an ALS subject. ALS subjects decline on the MMT
scale over time as the disease progresses and their symptoms
worsen.
Dr. Benjamin Rix Brooks, principal investigator, commented,
“This composite endpoint provides information that ibudilast may
delay ALS progression in some patients and this may benefit
survival. The proportion of responders was higher,
approximately one in three (11/34), in ALS subjects who started
ibudilast rather than placebo during the Double-Blind epoch. This
degree of response is more than seen in natural history studies
involving thousands of ALS patients in the PRO-ACT database and is
greater than those provided by current ALS treatments. Future
clinical trials of ibudilast and other treatments in ALS may
benefit from use of this novel clinical endpoint in Phase 2 and
Phase 3 clinical trials.”
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer
of MediciNova, Inc., commented, "We are very pleased with the
results of this analysis which indicates that MN-166 may improve
survival in this devastating and fatal disease. Based on the
positive results from this study, we are planning to discuss the
next steps in our development plan with FDA.”
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 60mg of MN-166
(ibudilast) per day in early and advanced stage ALS patients.
All subjects in the study received 100mg 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 28th International Symposium on ALS/MND in
Boston, MA in December 2017. There was a higher rate 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 next
study 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 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, 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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