PRESS RELEASE
AB SCIENCE HAS
BEEN GRANTED AUTHORIZATION TO INITIATE
CONFIRMATORY PHASE III
TRIAL OF MASITINIB IN PROGRESSIVE FORMS OF
MULTIPLE SCLEROSIS BY THE FRENCH
HEALTH AUTHORITY (ANSM)
Paris, 03 January, 2021, 6pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announces that it has been authorized by
the French Medicine Agency, ANSM, to initiate a Phase III study
(AB20009) evaluating masitinib in patients with Primary Progressive
Multiple Sclerosis (PPMS) or non-active Secondary Progressive
Multiple Sclerosis (nSPMS).
Study AB20009 is titled ‘A 96-Week, Prospective,
Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3
Study to Compare Efficacy and Safety of Masitinib Dose Titration to
4.5 mg/kg/day versus Placebo in the Treatment of Patients with
Primary Progressive or Secondary Progressive Multiple Sclerosis
Without Relapse’.
The study will enroll 800 patients from numerous
study centers with Expanded Disability Status Scale (EDSS) score
between 3.0 to 6.0 and absence of T1 Gadolinium-enhancing brain
lesions as measured by magnetic resonance imaging (MRI).
The primary objective of the study will be to
evaluate the effect of masitinib on time to confirmed disability
progression, with progression defined as 1-point worsening when
EDSS baseline score ≤5.5, or 0.5 if baseline score >5.5 from
randomization to week 96.
Professor Patrick Vermersch, MD, principal
investigator of the study and Professor of Neurology at the
University of Lille, France commented, “We are very excited to
initiate this confirmatory phase III study with masitinib in
progressive forms of multiple sclerosis. To date, the vast majority
of treatments for the management of multiple sclerosis target the
patient's adaptive immune system and therefore apply mainly to the
relapsing remitting forms of the disease. However, patients
suffering from a progressive form of the disease currently account
for approximately 50% of MS cases.”
Professor Olivier Hermine, President of the
Scientific Committee of AB Science and member of the Académie des
Sciences in France said, “To date, there is no treatment capable of
effectively targeting those cells of the innate immune system that
are associated with the pathology of progressive forms of multiple
sclerosis. Masitinib selectively targets these cells. Furthermore,
masitinib is not an immunosuppressive treatment, which is
particularly important in MS patients who need to receive long-term
treatment and who, in certain cases, already have a weakened immune
system due to previous treatments or because of their age.”
This confirmatory study follows successful
completion of a first Phase 2B/3 study (AB07002) in primary
progressive (PPMS) and non-active secondary progressive (nSPMS)
multiple sclerosis. Results from that study were presented during
the 8th Joint Americas Committee for Treatment and Research in
Multiple Sclerosis (ACTRIMS) – European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) Meeting (MSVirtual2020).
The study met its primary analysis endpoint, demonstrating a
statistically significant reduction in cumulative change on EDSS
with masitinib 4.5 mg/kg/day (p=0.0256). This treatment-effect was
consistent for PPMS and nSPMS. In addition, masitinib significantly
reduced the risk of first disability progression by 42% and the
risk of confirmed (3 months) disability progression by 37%.
Masitinib also significantly reduced the risk of reaching an EDSS
score of 7.0, corresponding to disability severe enough that the
patient is restricted to a wheelchair (p=0.0093).
A strong medical need for the
progressive forms of multiple sclerosisMultiple sclerosis
is an autoimmune disease of the central nervous system that affects
more than 100,000 people in France and for which no definitive
treatment exists to date. It is characterized by a progressive
degradation of the nerve cells of the central nervous system by the
patient's immune system and comes in two main forms.The
relapsing-remitting form characterized by relapses of the disease.
During these relapses, patients experience the onset of new
symptoms or the worsening of symptoms already present. These
flare-ups are usually followed by recovery periods of varying
length, after which some symptoms may persist. The
relapsing-remitting forms of multiple sclerosis are mostly
associated with dysfunctions of adaptive immunity (B cells and T
cells).The progressive form, characterized by a constant and
regular worsening of the symptoms of the disease, without a
distinct relapse or period of recovery. The rate of onset of
severe, disabling, and irreversible disability is much higher in
the progressive forms of the disease than in the relapsing
remitting forms. In progressive multiple sclerosis, innate immune
cells such as macrophages, microglia or mast cells have been shown
to probably play a major role.
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@rooneypartners.com
+1 212 223 0561
Media Relations – France
NewCapArthur
Rouilléarouille@newcap.fr
+33 (0)1 44 71 00 15
- CP Phase III MS ANSM VEng VF
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