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 clinical data
from ad-hoc subgroup 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.
The ad-hoc subgroup analyses include data from (1) the “Early
ALS subgroup” which is 31 subjects who had either bulbar onset or
upper limb onset out of a total of 49 subjects without non-invasive
ventilation in the full analysis set and (2) the “Early ALS + NIV
subgroup” which is 39 subjects who had either bulbar onset or upper
limb onset out of a total of 67 subjects with and without
non-invasive ventilation in the full analysis set. The full
analysis set includes all randomized subjects who received at least
14 days of study drug and had at least one post-dose efficacy
measurement. The subgroup analyses were completed for the ALSFRS-R
total score, the ALSAQ-5 score, and the Manual Muscle Test. A
responder was defined as a subject who did not worsen on the score
(i.e., the subject improved on the score or had no change on the
score) at the end of the 6-month double-blind period. Results of
the subgroup analyses are as follows:
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
(ALSFRS-R) Total Score
ALSFRS-R, which includes 12 questions that can have a score of 0
to 4, measures functional activity and has been useful in
diagnosing and measuring disease progression.
Early ALS subgroup
- There was a higher percentage of responders in the MN-166
(ibudilast) group compared to the placebo group. 30.0% (6/20) of
subjects in the MN-166 (ibudilast) group were responders on the
ALSFRS-R total score compared to 9.1% (1/11) of subjects in the
placebo group.
- There was a higher percentage of subjects who improved in the
MN-166 (ibudilast) group compared to the placebo group. 25.0%
(5/20) of subjects in the MN-166 (ibudilast) group improved on the
ALSFRS-R total score compared to 0.0% (0/11) of subjects in the
placebo group at the end of the 6-month double-blind period.
Early ALS + NIV subgroup
- There was a higher percentage of responders in the MN-166
(ibudilast) group compared to the placebo group. 26.9% (7/26) of
subjects in the MN-166 (ibudilast) group were responders on the
ALSFRS-R total score compared to 7.7% (1/13) of subjects in the
placebo group.
- There was a higher percentage of subjects who improved in the
MN-166 (ibudilast) group compared to the placebo group. 23.1%
(6/26) of subjects in the MN-166 (ibudilast) group improved on the
ALSFRS-R total score compared to 0.0% (0/13) of subjects in the
placebo group at the end of the 6-month double-blind period.
ALSFRS-R Total Score |
MN-166 + riluzole |
Placebo + riluzole |
p value |
Early ALS subgroup |
Responder |
30.0% (6/20) |
9.1% (1/11) |
p=0.1916 |
Improver |
25.0% (5/20) |
0.0% (0/11) |
p=0.0912 |
Early ALS + NIV subgroup |
Responder |
26.9% (7/26) |
7.7% (1/13) |
p=0.1644 |
Improver |
23.1% (6/26) |
0.0% (0/13) |
p=0.0706 |
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)
Score
ALSAQ-5 measures the physical mobility, activities of daily
living and independence, eating and drinking, communication, and
emotional functioning.
Early ALS subgroup
- There was a higher percentage of responders in the MN-166
(ibudilast) group compared to the placebo group. 60.0% (12/20) of
subjects in the MN-166 (ibudilast) group were responders on the
ALSAQ-5 score compared to 9.1% (1/11) of subjects in the placebo
group (p=0.0071).
Early ALS + NIV subgroup
- There was a higher percentage of responders in the MN-166
(ibudilast) group compared to the placebo group. 50.0% (13/26) of
subjects in the MN-166 (ibudilast) group were responders on the
ALSAQ-5 score compared to 23.1% (3/13) of subjects in the placebo
group.
ALSAQ-5 Score Responder |
MN-166 + riluzole |
Placebo + riluzole |
p value |
Early ALS subgroup |
60.0% (12/20) |
9.1% (1/11) |
p=0.0071 |
Early ALS + NIV subgroup |
50.0% (13/26) |
23.1% (3/13) |
p=0.1017 |
Manual Muscle Testing (MMT)
MMT measures the muscle strength of an ALS subject.
Early ALS subgroup
- There was a higher percentage of responders in the MN-166
(ibudilast) group compared to the placebo group. 35.0% (7/20) of
subjects in the MN-166 (ibudilast) group were responders on the MMT
score compared to 18.2% (2/11) of subjects in the placebo
group.
Early ALS + NIV subgroup
- There was a higher percentage of responders in the MN-166
(ibudilast) group compared to the placebo group. 34.6% (9/26) of
subjects in the MN-166 (ibudilast) group were responders on the MMT
score compared to 23.1% (3/13) of subjects in the placebo
group.
MMT Score Responder |
MN-166 + riluzole |
Placebo + riluzole |
p value |
Early ALS subgroup |
35.0% (7/20) |
18.2% (2/11) |
p=0.2866 |
Early ALS + NIV subgroup |
34.6% (9/26) |
23.1% (3/13) |
p=0.3626 |
MediciNova has requested a meeting with the FDA to discuss the
study design for the next ALS trial.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer
of MediciNova, Inc., commented, "We are very pleased with the
results of these new analyses which indicate that MN-166 could
improve outcomes in this devastating and fatal disease. We believe
this is a direct result of MN-166’s mechanism of enhancing the
production of neurotrophic factors including nerve growth factor.
We look forward to meeting with the 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 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). 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 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 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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