AB Science announces the filing of masitinib in the treatment of amyotrophic lateral sclerosis (ALS) to the European Medicine...
September 29 2016 - 12:03PM
AB Science SA (NYSE Euronext - FR0010557264 - AB), a
pharmaceutical company specialized in the research, development and
marketing of protein kinase inhibitors (PKIs), announces today the
acceptance and validation from the European Medicines Agency (EMA)
of the filing of masitinib in the treatment of amyotrophic lateral
sclerosis (ALS), also known as Lou Gehrig's disease, for
conditional marketing authorization. The review process started on
12 September 2016.
Filing for the Marketing Authorization of
masitinib in ALS was done on the basis of the positive results of
the predefined interim analysis of the phase 2/3 study AB10015
(press release of April 11 2016). This filing was also done on the
basis of preclinical data showing neuroprotective effect of
masitinib in amyotrophic lateral sclerosis through targeting of
microglial cells, published in the review Journal of
Neuroinflammation (press release of July 11 2016).
On the basis of the interim analysis results,
the Rapporteurs appointed by the EMA have recommended the filing of
masitinib in combination with riluzole in the treatment of adult
patients with amyotrophic lateral sclerosis (ALS) for conditional
marketing authorization.
On the basis on these results, masitinib also
received from European Medicines Agency (EMA) Committee for Orphan
Medicinal Products (COMP) the Orphan Drug Designation and FDA
approved first compassionate use of masitinib in amyotrophic
lateral sclerosis.
The phase 2/3 study AB10015 was a double-blind,
placebo-controlled study to compare the efficacy and safety of
masitinib in combination with riluzole versus placebo in
combination with riluzole in the treatment of patients suffering
from amyotrophic lateral sclerosis (ALS). In accordance with study
protocol, an interim analysis was planned to be performed once 191
patients (50% of the study population) had reached the 48-week
treatment time point. The interim analysis primary endpoint was
based on the change from baseline to week 48 in the revised
Amyotrophic Lateral Sclerosis Functional Rating Scale
(ALSFRS-R).
The interim analysis was designed to be a
success if the pre-specified difference between treatment groups
could be detected with a p-value below 0.0311.
The primary analysis was a success, with p-value
< 0.01 in the intention-to-treat (ITT) population. All
sensitivity analyses on the primary endpoint were also positive.
The study was also successful on its secondary endpoints, FVC and
CAFS. The frequency of adverse events (AEs), serious AEs, and AEs
leading to discontinuation were similar between the two treatment
arms.
EMA decision on registering masitinib in ALS
should be known during the second half of 2017.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis is a rare
degenerative disorder that results in progressive wasting and
paralysis of voluntary muscles. There are approximately 50,000
people with ALS in the European Union and in the US, with more than
16,000 new cases diagnosed each year in Europe and in the US.
Almost 80% of ALS patients die within 5 years and 90% die within 10
years.
About masitinib
Masitinib is a new orally administered tyrosine
kinase inhibitor that targets mast cells and macrophages, important
cells for immunity, through inhibiting a limited number of kinases.
Based on its unique mechanism of action, masitinib can be developed
in a large number of conditions in oncology, in inflammatory
diseases, and in certain diseases of the central nervous system. In
oncology due to its immunotherapy effect, masitinib can have an
effect on survival, alone or in combination with chemotherapy.
Through its activity on mast cells and microglia and consequently
the inhibition of the activation of the inflammatory process,
masitinib can have an effect on the symptoms associated with some
inflammatory and central nervous system diseases and the
degeneration of these diseases.
About AB Science
Founded in 2001, AB Science is a pharmaceutical
company specializing in the research, development and
commercialization of protein kinase inhibitors (PKIs), a
class of targeted proteins whose action are key in signaling
pathways within cells. Our programs target only diseases with high
unmet medical needs, often lethal with short term survival or rare
or refractory to previous line of treatment in cancers,
inflammatory diseases, and central nervous system diseases, both in
humans and animal health.
AB Science has developed a proprietary portfolio
of molecules and the Company's lead compound, masitinib, has
already been registered for veterinary medicine in Europe and in
the USA. The company is currently pursuing twelve phase 3 studies
in human medicine in first-line and second-line GIST, metastatic
melanoma expressing JM mutation of c-Kit, multiple myeloma,
metastatic colorectal cancer, metastatic prostate cancer,
pancreatic cancer, T-cell lymphoma, severe asthma uncontrolled by
oral corticosteroid, Alzheimer's disease, progressive forms of
multiple sclerosis, and amyotrophic lateral sclerosis. The company
is headquartered in Paris, France, and listed on Euronext Paris
(ticker: AB).
Further information is available on AB Science's
website: www.ab-science.com
This document contains prospective information.
No guarantee can be given as for the realization of these
forecasts, which are subject to those risks described in documents
deposited by the Company to the Authority of the financial markets,
including trends of the economic conjuncture, the financial markets
and the markets on which AB Science is present.
AB Science - Financial Communication & Media
Relations
investors@ab-science.com
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