AB Science announced that it has received new authorizations to resume patient enrollment in its Phase 3 studies of masitinib
15 September 2021 - 2:01AM
AB Science announced that it has received new authorizations to
resume patient enrollment in its Phase 3 studies of masitinib
PRESS RELEASE
AB SCIENCE ANNOUNCES THAT IT HAS
RECEIVED NEW AUTHORIZATIONS TO RESUME PATIENT ENROLLMENT IN ITS
PHASE 3 STUDIES OF MASITINIB, CONFIRMING
A GLOBAL RESUMPTION OF
THESE STUDIES
Paris, September 14 2021, 6pm CET
AB Science SA (Euronext -
FR0010557264 - AB) announced today that it has received
authorization from the French National Agency for the Safety of
Medicines and Health Products (ANSM) to resume patient enrollment
in the confirmatory Phase 3 study of masitinib (AB19001) in
amyotrophic lateral sclerosis, and also authorization from the UK
(MRHA) and Dutch (CCMO) National Agencies of Medicine in the
confirmatory Phase 3 study of masitinib (AB15003) in
mastocytosis.
These authorizations follow the validation in
July 2021 by the ANSM [1] of the measures proposed by AB Science to
reinforce patient safety related to cardiac risk in its ongoing
studies.
These authorizations follow those already
received from European agencies [2], in amyotrophic lateral
sclerosis (Norway) and in mastocytosis (France), and confirm a
global resumption of these studies.
[1] Press release dated July 12, 2021[2] Press releases of
August 23, 2021 and August 25, 2021
About amyotrophic lateral
sclerosisAmyotrophic lateral sclerosis (ALS) is a fatal
motor neuron disorder that is characterized by progressive loss of
the upper and lower motor neurons at the spinal or bulbar level.
The disease belongs to a group of disorders known as motor neuron
diseases, which are characterized by the gradual degeneration and
death of motor neurons. In ALS, both the upper motor neurons and
the lower motor neurons degenerate or die, and stop sending
messages to muscles. The prevalence of ALS in western countries is
fairly uniform at 6 per 100,000 persons, corresponding to around
30,000 cases in Europe and 20,000 in the USA.The first drug
treatment for ALS, riluzole (Rilutek), was approved in 1995. In
Europe, there has been no new treatment approved since
riluzole.
About indolent systemic
mastocytosisIndolent systemic mastocytosis (ISM) is a
hematological disease characterized by an abnormal number and
activation of mast cells in the bone marrow and other organs. The
disease if characterized by multiple symptoms that are disabling
and can in some cases be life-threatening. Symptoms associated ISM
are predominantly associated with neurological disorders
(depression, fatigue, cognitive impairment, headache), skin
disorders (pruritus, skin lesions), flushing and gastro-intestinal
disorders. ISM affects approximately 40,000 people in Europe and
25,000 in the USA. There is currently no therapy approved for the
treatment of ISM.
About masitinibMasitinib is a
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 ScienceFounded 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.
AB Science has developed a proprietary portfolio of molecules and
the Company’s lead compound, masitinib, has already been registered
for veterinary medicine and is developed in human medicine in
oncology, neurological diseases, inflammatory diseases and viral
diseases. 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.
Forward-looking Statements - AB
ScienceThis press release contains forward-looking
statements. These statements are not historical facts. These
statements include projections and estimates as well as the
assumptions on which they are based, statements based on projects,
objectives, intentions and expectations regarding financial
results, events, operations, future services, product development
and their potential or future performance.
These forward-looking statements can often be
identified by the words "expect", "anticipate", "believe",
"intend", "estimate" or "plan" as well as other similar terms.
While AB Science believes these forward-looking statements are
reasonable, investors are cautioned that these forward-looking
statements are subject to numerous risks and uncertainties that are
difficult to predict and generally beyond the control of AB Science
and which may imply that results and actual events significantly
differ from those expressed, induced or anticipated in the
forward-looking information and statements. These risks and
uncertainties include the uncertainties related to product
development of the Company which may not be successful or to the
marketing authorizations granted by competent authorities or, more
generally, any factors that may affect marketing capacity of the
products developed by AB Science, as well as those developed or
identified in the public documents published by AB Science. AB
Science disclaims any obligation or undertaking to update the
forward-looking information and statements, subject to the
applicable regulations, in particular articles 223-1 et seq. of the
AMF General Regulations.
For additional information, please contact:
AB ScienceFinancial
Communication & Media Relations investors@ab-science.com
Media Relations – USA
RooneyPartnersKate
Barrettekbarrette@rooneyco.com
+1 646 432 0191
Media Relations – France
NewCapArthur
Rouilléarouille@newcap.fr
+33 (0)1 44 71 00 15
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