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 principal
investigator Dr. Benjamin Rix Brooks, Director, Carolinas
HealthCare System's Neuromuscular/ALS-MDA Center, today presented
exploratory interim data from MediciNova's ongoing clinical trial
of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) at the
American Academy of Neurology (AAN) 69th Annual Meeting in Boston.
The exploratory interim analysis of survival rate was conducted
on 47 randomized ALS patients without non-invasive ventilator
support who completed per-protocol treatment (PP group=completed
both the 6-month double-blind and the 6-month open-label extension
period, n =31) vs. subjects who withdrew from the study before the
open-label period (ET group=early terminated, n =16). Survival rate
after open-label period was significantly higher in the group of
subjects who completed the entire treatment (i.e., the PP group)
than in the group of subjects who withdrew prior to the open-label
period (i.e., the ET group p=0.007).
The exploratory interim analysis of muscle strength evaluated 26
subjects who completed the entire study period (i.e., PP group) and
post 2-week evaluation. These 26 subjects were sorted into
sub-groups by type of onset of ALS, including bulbar-onset and
limb-onset. The exploratory interim analysis compared
clinical outcomes for these subjects at two time points, Month 12
(the end of the 6-month open-label extension period) vs. Month 12 +
2 weeks (after two weeks without MN-166), to determine the effect
of stopping MN-166 (ibudilast) treatment on clinical
outcomes.
Major highlights from this exploratory interim analysis include
the sub-group analysis sorted by type of onset of ALS, which are
summarized below.
1. There were significant decreases in muscle strength two weeks
after stopping MN-166 (ibudilast) for hip, leg and neck flexion
measured by Manual Muscle Testing:Bulbar-onset sub-group
(n=9)
- hip flexion in bulbar-onset patients (p=0.023*)
- leg flexion in bulbar-onset patients (p=0.051)
- neck flexion in bulbar-onset patients (p=0.021*)
Limb–onset sub-group (n=17)
- hip flexion in limb-onset patients (p=0.020*)
- leg flexion in limb-onset patients (p=0.219)
- neck flexion in limb-onset patients (p=0.083)
All ALS patients (n=26)
- Hip Flexion, a measure of hip muscle strength (p=0.001*)
- Leg Flexion, a measure of leg muscle strength (p=0.049*)
- Neck Flexion, a measure of neck muscle strength (p=0.004*)
* statistically significant
2. Lower-motor-neuron ALS burden significantly deteriorated in
Limb-onset subjects, however, no significant change was observed in
Bulbar-onset subjects compared at baseline and Month 12 as measured
by Brisbane-Sydney UMN-LMN ALS burden scale (arm-onset patient
p=0.0001, leg-onset patients, p=0.0004).
Dr. Benjamin Brooks, Director, Carolinas HealthCare System's
Neuromuscular/ALS-MDA Center, commented “We are encouraged by the
interim data thus far from this exploratory analysis. This
sub-group analysis suggests that the bulbar-onset ALS patient may
be a target for future clinical trials because we found no change
in lower motor neuron ALS burden on the Brisbane-Sydney UMN LMN ALS
Burden Scale in this subgroup, but further analysis is needed as
perhaps this is not the only responsive group but only the group
that we can see in a clinical trial designed as we did.”
About the ALS Trial
MediciNova, in collaboration with Dr. Benjamin Rix Brooks,
Director, Carolinas HealthCare System's Neuromuscular/ALS-MDA
Center, is currently evaluating MN-166 (ibudilast) in both early
and advanced stage ALS patients. This ongoing trial is a
randomized, double-blind, placebo-controlled study which includes a
six-month treatment period followed by a six-month open-label
extension. The study is evaluating several efficacy endpoints
including functional activity (ALSFRS-R), respiratory function and
muscle strength in subjects with ALS.
About Brisbane Sydney UMN LMN ALS Burden
Scale
This scoring system was developed by Devine and colleagues
(Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration.
2016;17(3-4):184-90) to assess upper or lower motor
neuron weakness and ability to predict prognosis. When utilized in
early stage of disease, the Brisbane-Sydney UMN LMN ALS Burden
Scale, along with other variables (age, bulbar, respiratory
status), provides an accurate estimate of outcome.
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 totally
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. Riluzole is the only
pharmaceutical treatment approved for ALS, but it has limited
efficacy.
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 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 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
Forms 10-Q and 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'Brien
Vice President
MediciNova, Inc.
info@medicinova.com
Medicinova (NASDAQ:MNOV)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medicinova (NASDAQ:MNOV)
Historical Stock Chart
From Sep 2023 to Sep 2024