AB Science receives regulatory authorization to commence a second
Phase 2 Covid-19 study
PRESS RELEASE
AB SCIENCE
RECEIVES REGULATORY
AUTHORIZATION TO COMMENCE
A SECOND PHASE 2
COVID STUDY
STUDY DESIGN FOCUSES
DIRECTLY ON MASITINIB’S ANTIVIRAL
ACTIVITY AGAINST THE COVID-19 VIRUS
(SARS-CoV-2) FOR
THE TREATMENT OF PATIENTS AT AN EARLY STAGE OF THE
DISEASE
WITH TWO
PHASE 2 STUDIES,
MASITINIB IS A LEADING CANDIDATE IN THE DEVELOPMENT OF
ORAL PROTEASE INHIBITORS
FOR TREATMENT OF NON-HOSPITALIZED AND HOSPITALIZED COVID-19
PATIENTS
Paris, 28 September, 2021, 7pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announced that a new clinical trial with
masitinib in patients with symptomatic mild and moderate COVID-19
has been approved by the Regulatory Authorities of Russia and South
Africa. Study AB21002, the second Phase 2 study of masitinib in
COVID-19, is titled ‘A randomized, double-blind,
placebo-controlled, phase 2 clinical trial to evaluate the
antiviral efficacy of masitinib in patients with symptomatic mild
to moderate COVID-19’.
Masitinib is being developed as a novel
SARS-CoV-2 protease inhibitor antiviral therapy, with two phase 2
studies in the complementary populations of non-hospitalized
(non-severe) and hospitalized (severe) COVID-19 patients. Masitinib
is considered particularly well-suited for the treatment of
COVID-19 soon after infection (prior to hospitalization), when an
antiviral is likely to have most effect and because of its
convenient oral (tablet) administration. Currently, masitinib is
one of the most advanced oral protease inhibitor antiviral drugs in
clinical development, as its safety is well-known, having already
been evaluated on thousands of patients in other indications.
Study AB21002 will evaluate the antiviral
efficacy of masitinib at 3 different dosages, administered as an
add-on to best supportive care, with respect to placebo plus best
supportive care. The study will enroll 78 patients (age ≥18 without
an upper age limit) at medical centers in France and other
countries. The primary efficacy objective will be to demonstrate
that masitinib can reduce the viral load of SARS-CoV-2 (the virus
responsible for COVID-19) faster than a placebo control group,
which will receive best supportive care. The population of study
AB21002 therefore targets ambulatory (non-hospitalized) patients
with mild disease or hospitalized patients without requirement for
non-invasive ventilation (a score of 4 and 5 on the WHO clinical
progression scale for COVID-19).
This clinical trial follows the discovery
published in the journal Science [1] that masitinib is a direct
antiviral drug blocking the replication of SARS-CoV-2 (the virus
that causes COVID-19), by inhibiting the critical non-structural
protein 5 (Nsp5) target (the main protease also named 3CLpro)
necessary for the viral replication cycle. In a mice model infected
with SARS-CoV-2, masitinib was shown to dramatically reduce the
viral load, the pro-inflammatory cytokines levels, and to improve
mice survival at clinically relevant dosages. Masitinib therefore
has a dual action against COVID-19; a direct antiviral mechanism of
action and also an anti-inflammatory action that that is of
relevance for treating COVID-19 related acute respiratory distress
syndrome and cytokine storm.
Professor Savas Tay, senior author of the
Science article [1] (Pritzker School for Molecular Engineering,
University of Chicago) previously commented that, “In a context
where we face the emergence of a number of SARS-CoV-2 variants of
concern, the development of efficacious antiviral therapeutics is
urgently needed. Because masitinib specifically targets the
catalytic residues of 3CLpro, its antiviral activity is likely to
be insensitive to genetic alterations of the Spike protein. Thus,
masitinib constitutes a uniquely valuable therapeutic option for
both ancestral SARS-CoV-2 and variants against which vaccines or
monoclonal antibodies may become less or not effective” [2].
Despite the availability of effective vaccines,
the need for antiviral therapeutics will remain high because a
substantial part of the world population will not be vaccinated. In
addition, SARS-CoV-2 is rapidly evolving, leading to the selection
and accumulation of mutations, mainly in the Spike protein, that
affect the transmissibility of the virus, its ability to evade
immunity and its suspected pathogenicity. Variants of concern are
more contagious and susceptible of immune escape, thereby
challenging monoclonal antibodies (mAbs) therapies, threatening the
protective efficacy of current vaccines and leading to waves of
coronaviruses.
At this time, there is a lack of antiviral
compounds available to treat COVID-19. Consequently, there is an
urgent need to develop new antiviral compounds in order to counter
emerging variants of concerns.
The development of effective antiviral therapies is based on two
complementary strategies:
- Drugs targeting the polymerase:
Several drugs targeting polymerase are currently in clinical
development, with remdesivir (Gilead) being approved.
- Drugs targeting the protease: Drugs
targeting viral 3C-like protease (as is the case for masitinib) are
an attractive therapeutic option for COVID-19, in part because they
are considered less vulnerable to the development of SARS-CoV-2
drug resistance; however, no such drugs targeting 3C-like protease
are yet registered for use in the treatment of COVID-19.
As is the case to treat HIV (human
immunodeficiency virus), it is expected that an effective treatment
strategy against SARS-CoV-2 would depend on the combination of
drugs targeting both the polymerase and the protease of the
virus.
Reference[1] 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
[2] Press release dated April 6, 2021.
www.ab-science.com/signing-of-an-exclusive-licensing-agreement-with-the-university-of-chicago-to-conduct-research-for-the-prevention-and-treatment-of-covid-19/
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@rooneypartners.com
+1 212 223 0561
Media Relations – France
NewCapArthur
Rouilléarouille@newcap.fr
+33 (0)1 44 71 00 15
- CP COVID AB21002 ANTI-VIRAL vENG VF
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