AB Science granted authorization by ANSM to initiate Phase 2 study evaluating masitinib in combination with isoquercetin for ...
06 Mai 2020 - 2:03PM
AB Science granted authorization by ANSM to initiate Phase 2 study
evaluating masitinib in combination with isoquercetin for the
treatment of COVID-19
Paris, May 06, 2020, 2pm
AB Science granted authorization by French
Medicine Agency (ANSM)to initiate Phase 2 study
evaluating masitinib in combination with isoquercetin
for the treatment of COVID-19
Company to host live webcast on Monday May
11, 2020, 5.30pm CET
AB Science SA (NYSE Euronext -
FR0010557264 - AB) today announces initiation of a Phase 2 study
evaluating masitinib in combination with isoquercetin for the
treatment of COVID-19, following rapid review and acceptance
received from the French Medicine Agency, ANSM.
This study (AB20001) is a randomized (1:1),
open-label Phase 2 clinical trial to evaluate the safety and
efficacy of masitinib combined with isoquercetin in hospitalized
patients with moderate and severe COVID-19.
The study will enroll 200 patients (age ≥18
without an upper age limit) at medical centers in France and other
countries. The primary objective is to improve the clinical status
of patients after 15 days of treatment.
A webcast call will be held on Monday May 11,
2020 at 5.30pm CET to present the detailed study design and further
explain the scientific rationale for combining masitinib with
isoquercetin.
Dial-in & webcast information will be
provided later.
Many patients with moderate and severe COVID-19,
develop a “cytokine storm” that leads to severe pulmonary
inflammation and various thrombotic events associated with acute
respiratory distress syndrome (ARDS) and potentially death. The
combination of masitinib and isoquercetin may prevent the
development of these two complications.
- masitinib is a potent blocker of mast cells and macrophages
that are contributors to the cytokine storm
- isoquercetin inhibits disulfide isomerase (PDI), an enzyme
directly involved in the formation of clots and decreases D-Dimer,
a predictor of COVID-19 thrombosis severity.
- the combination of masitinib and isoquercetin has a synergistic
effect against senescent cells, a potential target of the virus
that could explain the higher mortality rates in the elderly.
Pascal Chanez, Professor of Respiratory Medicine
at the AP-HM and Aix Marseille University at Marseille, France and
principal investigator said “The combination of masitinib with
isoquercetin is based on a strong scientific rationale and offers a
differentiated strategy. On the one hand, masitinib and
isoquercetin have upstream activity to prevent cytokine storm and
its associated lung injuries and thrombosis, and on the other hand,
the combination has a totally innovative synergistic effect to
target the senescent cells, which could protect the most vulnerable
aged population. The enrolment of patients in this study will
primarily come from the second wave of the disease”.
About the study primary
endpoint
The 7-point ordinal scale for clinical status
is: 1. Not hospitalized, no limitations on activities; 2.Not
hospitalized, limitation on activities; 3. Hospitalized, not
requiring supplemental oxygen; 4. Hospitalized, requiring
supplemental oxygen; 5. Hospitalized, on non-invasive ventilation
or high flow oxygen devices; 6. Hospitalized, on invasive
mechanical ventilation or ECMO; 7. Death.
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, and inflammatory 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 filed by AB Science with the
Autorité des Marchés Financiers (AMF), including those listed in
the Chapter 4 "Risk Factors" of AB Science reference document filed
with the AMF on November 22, 2016, under the number R. 16-078. 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
- Authorisation phase 2 Covid vEng VF
Ab Science (EU:AB)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Ab Science (EU:AB)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024