AB Science announced today that it has received authorization to resume patient enrollment in the phase 2 masitinib study of COVID-19 (AB20001)
17 September 2021 - 3:34AM
AB Science announced today that it has received authorization to
resume patient enrollment in the phase 2 masitinib study of
COVID-19 (AB20001)
PRESS RELEASE
AB SCIENCE ANNOUNCES THAT IT HAS
RECEIVED AUTHORIZATION TO RESUME PATIENT ENROLLMENT IN ITS
PHASE 2
COVID-19 STUDY
OF MASITINIB, SIGNIFIYING
RESUMPTION OF RECRUITMENT IN ALL
THREE OF ITS ONGOING MASITINIB STUDIES
Paris, 16 September 2021, 7.30pm CET
AB Science SA (Euronext -
FR0010557264 - AB) announced today that it has received
authorization from the Russian Health Ministry (MoH) to resume
patient enrollment in the phase 2 masitinib study of COVID-19
(AB20001).
This latest authorization signifies that the
measures proposed by AB Science to reinforce patient safety related
to cardiac risk are adequate for all three of its ongoing masitinib
studies.
Authorizations to resume patient enrollment have
already been received from European and National agencies [1] [2]
for the confirmatory Phase 3 study (AB19001) in amyotrophic lateral
sclerosis and the confirmatory Phase 3 study (AB15003) in
mastocytosis.
Study AB20001 is a randomized (1:1),
double-blind, Phase 2 clinical trial to evaluate the safety and
efficacy of masitinib combined with isoquercetin in hospitalized
patients with moderate and severe COVID-19. 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 and potentially
death. The combination of masitinib and isoquercetin may prevent
the development of these two complications. Study AB20001 plans to
enroll 200 patients (age ≥18 without an upper age limit)) with a
primary objective to improve the clinical status of patients after
15 days of treatment.
The Data and Safety Monitoring Board (DSMB)
have met twice since the beginning of the study and have
recommended continuation of the study on both occasions.
Of major relevance to the development of
masitinib in COVID-19 is the recent publication of research article
in the journal Science that demonstrated the effectiveness of
masitinib as an anti-SARS-CoV-2 drug in animals [3]. Mice infected
with SARS-CoV-2 and then treated with masitinib showed >200-fold
reduction in viral titers in the lungs and nose, as well as
improved overall lung pathology and significantly reduced levels of
key pro-inflammatory cytokines. Overall, results showed that
masitinib rapidly and effectively reduced SARS-CoV-2 viral load in
mice (reducing >99% of the viral load on day 6), reduced
inflammatory signatures, and showed potential benefits for survival
and clinical scores. Remarkably, masitinib was also effective, in
vitro, against all tested variants of concern, including the
rapidly spreading Alpha, Beta and Gamma variants.
[1] Press release dated September 14, 2021[2] Press releases of
August 23, 2021 and August 25, 2021
[3] Drayman N, DeMarco JK, Jones KA, et al.
Masitinib is a broad coronavirus 3CL inhibitor that effectively
blocks replication of SARS-CoV-2. Science. 2021;373(6553). doi:
10.1126/science.abg5827
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.
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@rooneyco.com
+1 646 432 0191
Media Relations – France
NewCapArthur
Rouilléarouille@newcap.fr
+33 (0)1 44 71 00 15
- Reprise recrutement_3CT VEng VF
Ab Science (LSE:0Q77)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ab Science (LSE:0Q77)
Historical Stock Chart
From Apr 2023 to Apr 2024