AB Science is providing a summary of the live webcast held on June
3, 2021 following the voluntary hold in the clinical studies of
masitinib
PRESS RELEASE
SUMMARY OF THE
WEBCAST HELD ON JUNE 3, 2021 FOLLOWING THE
VOLUNTARY HOLD IN THE CLINICAL STUDIES OF MASITINIB
RESUMPTION OF TRADING ON WEDNESDAY JUNE
9, 2021
Paris, June 8, 2021, 8.30am
AB Science SA (NYSE Euronext -
FR0010557264 - AB) is providing a summary of the live webcast held
on June 3, 2021 following the voluntary hold in the clinical
studies of masitinib.
The presentation of the webcast, which includes
the most frequent questions, is available on the company’s
website.
The presentation has been delivered by AB
Science Medical and Safety team:
- Christian Fassotte, MD, Chief
Medical Officer of AB Science
- Peter De Veene, MD, Head of
Pharmacovigilance and Global Safety of AB Science
- Olivier Hermine, MD, PhD, Chief of
Adults Hematology staff at Hospital Necker in Paris, France,
president of AB Science scientific committee and member of the
French Académie des Sciences
AB Science’s shares, suspended from trading
since June 1st, 2021, will resume trading on Euronext Paris on
Wednesday June 9th, 2021 at the opening of its session.
Summary
- Studies continue for patients
already under treatment subject to documentation by the
investigator of the individual benefit/risk. These patients
continue to be dosed.
- AB Science took the decision to
temporarily hold the inclusions of new patients because of a
potential signal of ischemic heart disease.
- Investigations continue in close
collaboration with the agencies.
- Reinforced risk management plan is
a possible classic mitigation approach in such situations.
- This decision to suspend inclusions
reflects the priority of AB Science to protect patient’s safety
while investigations continue.
Overview
AB Science reiterated that patient safety is its
priory and justifies the decision to voluntarily put a temporary
hold on recruitment and randomization in the on-ongoing
studies.
After unblinding the phase 2B/3 studies with
masitinib, AB Science ran multiple safety analyses in a continuous
effort to detect signals. In one of the exploratory analyses,
pooling a subset of studies and a subset of patients, an imbalance
of events of Ischemic Heart Disease (IHD) between masitinib and the
control arm was detected, which might be interpreted as a signal of
increased risks of IHD.
As a consequence, the company consulted with
external experts and decided to perform a series of analysis called
meta-analysis on all available data from controlled and unblinded
study data:
- This meta-analysis was based on
Relative Risks (RR) of cardiovascular events based on multiple
categorizations of events from all studies
- This analysis relied on the
methodology described by the Cochrane Library (gold-standard
according to experts)
This meta-analysis did not confirm the signal.
These results were shared with national competent authorities
across the world. The French competent authority (ANSM) requested
some additional analyses and data to finalize its own
investigation.
Out of precaution, AB Science decided to hold
inclusions in on-going studies pending completion of these
investigations.
AB Science will communicate when investigations
are completed. In the meantime, AB Science works in close
relationship with ANSM, and also other agencies in the world, to
provide in a timely manner the requested additional analyses and
data.
Most frequent questions
What happens for the patients under
treatment?
Patients already under treatment at the time of
the decision can stay in the study at the investigator’s decision,
provided positive individual benefit/risk is documented. This
request has been approved by the ANSM, pending the completion of
on-going investigations.
Is this potential risk new?
Cardiotoxicity: Cardiotoxicity is an identified
risk with certain tyrosine kinase inhibitors (TKIs). This has been
identified at the beginning of the clinical development program as
a potential risk with masitinib based on TKI class-risk and data
from one animal toxicology study. This potential risk is already
described in the Investigator's Brochure and the Informed Consent
for the patient.
Ischemic heart disease (IHD): IHD is the new
signal we have detected and not an identified risk.
Were deaths reported from ischemic heart disease
(IHD) under masitinib?
Deaths from IHD have been reported both under
masitinib and placebo. Some patients present with comorbidities
that can lead to IHD in the course of the disease itself, and so
when patients enter a clinical study, such IHD events can happen
and also sometimes lead to major adverse cardiac events including
death, whether the receiving masitinib or the placebo. The role of
the pharmacovigilance is to continuously evaluate these events when
they occur, to analyze the medical history of the patients and many
other parameters to know if the drug may be involved in the more
frequent occurrence of these events.
Can you quantify the number of cases and the
seriousness of the cases?
Number of cases and difference between masitinib
and control vary across studies. Some ischemic events are of grade
1 such as pain in chest and others are grade 5 (death), both in
control and masitinib treatment arms. This is the analysis of all
studies and all parameters that give a signal.
What additional analyses requested by ANSM need
to be done?
Health Authorities usually do not rely solely on
sponsors’ analyses and request data to perform their own
assessment. Such data and analyses typically include raw data and
listings, detailed narratives, sensitivity analyses. AB Science is
actively cooperating in all transparency with all agencies and will
timely provide the requested information so that on-going
investigations can be completed.
When will you know the conclusion of the
investigation of this potential risk?
AB Science will communicate when investigations
are completed. In order to be conservative, we do not provide
forecasts. We work in close relationship with ANSM but also other
agencies in the world. Our current expectation is to be able to
address rapidly the requests from ANSM. Agencies, like us, are
patient-driven and reactive on this topic, in particular in
conditions with high unmet medical need.
Given the nature of this potential risk, does it
modify or prevent the benefit/risk in non-oncology indications to
be positive?
First, we don’t have the position of the agency.
Second, there is an expected benefit in each of the indications
pursued due to the positive clinical phase 2B/3 results, and based
on expected mechanism of action in COVID-19. Therefore, if this
potential risk is materialized, an assessment will be done
indication by indication. Moreover, the risk mitigation plan can be
adapted.
Safety was a strength of masitinib. Does it mean
the program is jeopardized?
Expected benefits are unchanged and still
present. What is at stake today is to determine if there is an
increased risk and how to protect the patients, including with risk
management measures such as new exclusion criteria and cardiology
preventive measures during the studies.
What is the probability that the studies do not
restart?
There will be a specific decision for each
study. The decision to restart for each study will depend on the
conclusion of the investigation of this risk. The Benefit/Risk
ratio will have to be analyzed based on these conclusions,
separately for each of the current and future development programs.
The Benefit/Risk ratio takes into account the existence or not of a
new risk, the risk management plan, the medical need, and the
benefit based on existing results.
Why you did not see this potential risk in
previous studies?
For each study, predefined analyses were
performed and did not identify any signal. When phase 2B/3 studies
were unblinded and large amount of safety data were pooled, there
was one analysis in a subset of studies and a subset of patients
that might be interpreted as a signal of increased risks of IHD.
After we generated this exploratory analysis, we performed multiple
other analyses, which did not at this time confirm the initial
signal. The situation is therefore contradictory at this stage and
that is why, since there is some doubt, we suspended the
inclusions.
Does this potential risk come from the on-going
studies?
This potential risk comes from a retrospective
analysis of subset of completed, controlled and unblinded studies,
not from on-going studies in ALS, mastocytosis, and COVID-19.
Why do you take these precautionary measures
only now?
After an initial analysis which detected a
signal on a study group, meta-analyzes performed on all the studies
did not confirm this signal. These analyzes are therefore
contradictory. The ANSM has requested additional data and analyzes.
Therefore, we concluded that a certain level of uncertainty remains
and that is why we suspended inclusions.
Why this potential risk has never been seen in
the past. You never did such analysis?
Cardiovascular events, including IHD, have
occurred in masitinib clinical studies. This potential risk has
been analyzed in the past but was not previously detected. This
potential signal comes after the unblinding of the phase 2B/3
studies.
Does this situation affect the data of past
studies?
The efficacy and safety data of completed
studies and study results remain unchanged. The Benefit/Risk will
be reassessed in each indication if the signal was confirmed and
depending on its magnitude.
Suspension of inclusion or discontinuation of
patients will delay by how much the program?
First, patients are not discontinued, subject to
documentation by the investigator of the individual benefit/risk.
The program will be extended by the duration between the hold and
the restart.
What is the position of other agencies apart
from ANSM?
We shared all the analyzes with all the agencies
and we will collaborate with these agencies in the same way as we
do with the ANSM.
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.
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