AB Science announces positive results of its Phase 2 study evaluating masitinib in Covid-19
08 Juli 2024 - 7:56AM
PRESS RELEASE
AB SCIENCE REPORTS POSTIVE RESULTS OF
ITS PHASE 2 STUDY EVALUATING MASITINIB IN COVID-19
Paris, 8 July 2024, 8am CET
AB Science SA (Euronext -
FR0010557264 - AB) today announces the results of a Phase 2 study
evaluating masitinib in COVID-19.
This randomized (1:1), open-label, phase 2 study
(AB20001) was designed to evaluate the safety and efficacy of
masitinib plus isoquercetin in hospitalized patients with moderate
COVID-19 (WHO 7-point ordinal scale level 4) or severe COVID-19
(level 5). The study initially planned to recruit 200 patients
(over 18 years of age with no upper age limit). The primary
objective was to improve the clinical status of patients after 15
days of treatment, as measured by the WHO 7-point ordinal scale.
Following a DSMB recommendation, decision was taken to continue the
study only in level 4 patients (i.e. hospitalized patients with
oxygen supply <6 L/min with SpO2 maintained ≥92%).
The study could not recruit the planned 200
patients. The decision was therefore taken to stop inclusion after
95 patients were randomized. The objective was to detect a trending
treatment effect with 95 patients that would translate into a
significant effect when simulating the same effect with the planned
enrolment of 200 patients. If this objective was reached, then the
conclusion would be that it is worth continuing to evaluate
masitinib as an agent in the treatment of covid in patients
hospitalized with moderate need of oxygen.
The study showed an odds ratio of 2.4 in favor
of the treatment arm after 15 days of treatment, superior to the
odds ratio of 2.2 initially hypothesized, with p=0.038 simulated
with 200 patients and p=0.072 detected with 95 patients recruited.
Sensitivity analyses at day 12, 13 and 14 with 95 patients
recruited displayed a p-value of respectively p=0.016, 0.019, 0.018
and odds ratio 3.2, 3.2 and 3.4. This was due to improvement of
certain placebo patients at day 15 but not before. The safety was
in line with the known safety profile of masitinib.
Professor Olivier Hermine, MD, President of the
Scientific Committee of AB Science and member of the Académie des
Sciences in France said: “This result confirms the
anti-inflammatory activity of masitinib, by controlling activated
macrophages and mast cells involved in COVID. In addition, several
publications highlighted the capacity of masitinib to act as an
indirect broad antiviral agent against COVID. With this result,
masitinib can be considered a drug of choice to be evaluated in the
context of a future pandemic”.
Alain Moussy, co-founder and CEO of AB Science
said: “We are thankful to the European Investment Bank for having
funded this development of masitinib in COVID, and to our partner
Quercegen for having proposed to combine masitinib with
isoquercetin. This result warrants further evaluation and we will
discuss such opportunity with public entities or private
partners”.
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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