AB Science provides an update on the application for conditional marketing authorisation of masitinib in ALS
28 Juni 2024 - 12:31PM
AB Science provides an update on the application for conditional
marketing authorisation of masitinib in ALS
PRESS RELEASE
AB SCIENCE PROVIDES AN UPDATE ON THE
APPLICATION FOR CONDITIONAL MARKETING AUTHORISATION OF MASITINIB IN
THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS
Paris, 28 June, 2024, 12:30pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announces that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted, in line with the trend vote, a negative opinion
on the application for conditional marketing authorization of
masitinib in the treatment of amyotrophic lateral sclerosis
(ALS).
AB Science intends to ask for re-examination on
the basis of:
1) First and foremost, the
urgent need for patients to have early access to a promising
treatment.
2) The opportunity of having
the dossier re-examined by new rapporteurs and by a Scientific
Advisory Board.
AB Science highlights the difficulty of a
conditional marketing authorization in ALS and cannot guarantee a
positive outcome following this re-examination.
The grounds to request a re-examination could be
based on the following elements:
-
Acceptable masitinib safety: First, the CHMP confirmed that the
safety of masitinib is deemed acceptable, which is a key
consideration in the context of a conditional marketing
authorization where confirmatory evidence of efficacy is
required.
-
Objection concerning deviations from Good Clinical Practice: As per
EMA guidance (EMA/868942/2011), impact analyses of all protocol
deviations that could not be corrected were performed and showed no
impact, resolving Good Clinical Practice issues as per
guideline.
-
Objection concerning the exclusion of fast progressors: The
amendment transitioning from phase 2 to phase 3 excluding fast
progressors from the primary analysis population was necessary and
well justified, in order to have a more homogenous population with
greater chance of reaching week 48 time point and minimizing
missing data. Furthermore, the amendment was implemented early
enough and while the study was blinded, removing any methodological
issues.
-
Objection concerning the treatment of missing data in the primary
analysis: Multiple sensitivity analysis of the primary analysis;
using non LOCF (Last Observation Carried Forward) methods for
imputation of missing data, are positive and consistent, including
two analyses previously recommended by the CHMP, demonstrating the
robustness of the primary analysis, thus resolving the objection
concerning the treatment of missing data.
-
Objection on the subgroup data: There was an important imbalance in
a subset of patients experiencing complete loss of function (i.e.,
ALSFRS-R score of zero) in one or more of the item scores (20% in
the masitinib arm versus 8% in the placebo arm), because ALSFRS-R
score was minimized but not stratified by category of severity. The
subgroup defined as patients prior to any complete loss of function
(i.e. excluding the overmentioned biased subset) accounted for 86%
of the population and showed extremely compelling results,
including a significant 12 months survival benefit. The subgroup
analysis is the strict application of EMA guidance
(EMA/CHMP/539146/2013), which is applicable to post hoc analysis
and to registration with single pivotal study, thus resolving the
objection regarding subgroup data.
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
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