AB Science announces a voluntary hold in the clinical studies of masitinib worldwide
01 Giugno 2021 - 6:59AM
PRESS RELEASE
AB SCIENCE ANNOUNCES A VOLUNTARY HOLD
IN THE CLINICAL STUDIES OF
MASITINIB WORLDWIDE
Paris, June 1st, 2021, 7am
AB Science SA (Euronext -
FR0010557264 - AB) announced today that it has taken the decision
to suspend inclusions and treatment initiation in its clinical
studies with masitinib worldwide. This decision follows
consultation with the French regulatory authorities (ANSM) and
other regulatory agencies. This decision is relevant to three
studies: phase 3 in mastocytosis (AB15003), phase 3 in amyotrophic
lateral sclerosis (AB19001) and phase 2 in COVID (AB20001). To this
end, AB Science has filed or will file without delay a request for
a temporary study hold in all countries where these studies are
ongoing.
AB Science has identified a potential risk of
ischemic heart disease with masitinib. This signal was detected in
a retrospective analysis of controlled and unblinded studies of
masitinib. Following its own internal procedures, AB Science has
decided to suspend inclusion in ongoing studies with masitinib
until the investigation of this potential safety issue is finished.
AB Science is working closely with the ANSM and other regulatory
agencies to complete the necessary additional analyses.
Patient safety is our priority. AB Science is
committed to continue the development of masitinib in the
indications initiated, while ensuring patient safety. AB Science is
working in full collaboration with the regulatory authorities in
order to resume patient enrollment in these studies.
About masitinibMasitinib 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 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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