PRESS RELEASE
AB SCIENCE RECEIVES U.S. FOOD AND DRUG
ADMINISTRATION (FDA) AUTHORIZATION TO RESUME
PATIENT ENROLMENT IN THE PHASE 3 STUDY OF
MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS (ALS)
STUDY AB19001 HAS
NOW BEEN AUTHORIZED IN 15
COUNTRIES IN EUROPE, USA, AND
OTHER REGIONS AND IS ACTIVELY ENROLLING
PATIENTS
Paris, 18 November 2021, 8.30pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announced that it has received
authorization from the United States Food and Drug Administration
(FDA) to resume patient enrollment in the confirmatory Phase 3
study of masitinib (AB19001) in patients with amyotrophic lateral
sclerosis (ALS).
Study AB19001 has been authorized in 15
countries in Europe, USA, and other regions and is actively
enrolling patients.
Dr Christian Fassotte, Chief Medical Officer of
AB Science said: “We are delighted with this decision that will
give US patients the opportunity to participate in this masitinib
confirmatory trial. The previous phase 2/3 trial demonstrated that
masitinib significantly slowed functional decline [1], with
long-term follow-up analysis showing a significantly prolonged
survival when masitinib is initiated at an early stage of disease
[2]. It is therefore important that people living with ALS are
given the opportunity to participate in this trial.”
Study AB19001 is an international, multicenter,
randomized, double-blind, placebo-controlled, 3-parallel group,
Phase 3 study to compare the efficacy and safety of masitinib in
combination with riluzole versus placebo in combination with
riluzole for the treatment of people suffering from ALS.
The study is intended to confirm the previously
published results from the first Phase 2b/3 study (AB10015), which
demonstrated that masitinib at 4.5 mg/kg/day in combination with
riluzole significantly slowed functional decline by 27% compared
with riluzole alone at week 48, as measured by change in ALSFRS-R
(Amyotrophic Lateral Sclerosis Functional Rating
Scale-revised).
Study AB19001 recruitment targets people with
ALS that have mild or moderate (non severe) impairment of
functionality at baseline. This is closely aligned with the patient
population that showed the greatest survival benefit with masitinib
in the long-term survival analysis. The primary endpoint of study
AB19001 is absolute change from baseline in functional score as
assessed by ALSFRS-R after 48 weeks of treatment.
References
[1] Mora JS, Genge A, Chio A, et al. Masitinib
as an add-on therapy to riluzole in patients with amyotrophic
lateral sclerosis: a randomized clinical trial. Amyotroph Lateral
Scler Frontotemporal Degener. 2020;21(1-2):5-14.
doi:10.1080/21678421.2019.1632346
[2] Mora JS; Bradley WG; Chaverri D, et al.
Long-term Survival Analysis of Masitinib in Amyotrophic Lateral
Sclerosis. Ther Adv Neurol Disord 2021, Vol. 14: 1–16 doi:10.1177/
17562864211030365
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 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.
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and their potential or future performance.
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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
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Rouilléarouille@newcap.fr
+33 (0)1 44 71 00 15
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