AB Science announces positive results from its phase 2 study evaluating masitinib in Covid-19

PRESS RELEASE

AB SCIENCE PUBLISHES POSTIVE RESULTS FROM ITS PHASE 2 STUDY EVALUATING MASITINIB IN COVID-19

Paris, July 8, 2024, 8:00 a.m. CET

AB Science SA (Euronext – FR0010557264 – AB) today announced 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 (WHO 7-point ordinal scale grade 4) or severe (grade 5) COVID-19. The study initially planned to enroll 200 patients (aged ≥18 years with no upper age limit). The primary objective was to improve patients’ clinical status after 15 days of treatment, as measured by the WHO 7-point ordinal scale. Following a recommendation from the DSMB, the decision was made to continue the study only in grade 4 patients (i.e., hospitalized patients with oxygen intake <6 L/min with SpO2 maintained ≥92%).

The study failed to recruit the planned 200 patients. The decision was therefore made to stop enrollment after randomization of 95 patients. The aim was to detect a trend treatment effect with 95 patients that would translate into a significant effect when simulating the same effect with the planned enrollment of 200 patients. If this objective were met, the conclusion would be that it is worthwhile to continue evaluating masitinib as an agent in the treatment of covid in hospitalized patients with moderate oxygen requirement.

The study showed an odds ratio of 2.4 in favour of the treatment group after 15 days of treatment, higher than the initially hypothesized odds ratio of 2.2, with p=0.038 simulated with 200 patients and p=0.072 detected with 95 patients enrolled. Sensitivity analyses at days 12, 13 and 14 with 95 patients enrolled showed a p-value of p=0.016, 0.019, 0.018 and an odds ratio of 3.2, 3.2 and 3.4, respectively. This was due to the improvement of some patients on placebo at day 15 but not before. Safety was consistent with the known safety profile of masitinib.

Professor Olivier Hermine, Doctor of Medicine, President of the Scientific Committee of AB Science and member of the French Academy of Sciences, said: “This result confirms the “The anti-inflammatory activity of masitinib, by controlling activated macrophages and mast cells involved in COVID. In addition, several publications have highlighted the ability of masitinib to act as a broad-spectrum indirect 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 thank the European Investment Bank for funding this development of masitinib in the treatment of COVID, and our partner Quercegen for proposing to combine masitinib with isoquercetin. This result deserves further evaluation and we will discuss this opportunity with public entities or private partners.“.

About AB Science
Founded in 2001, AB Science is a pharmaceutical company specialized in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action is key in signaling pathways within cells. Our programs target only diseases with high medical need, often fatal with a short survival rate, rare or refractory to a first line of treatment.
AB Science has developed its own portfolio of molecules and its lead compound, masitinib, has already been registered in veterinary medicine and is being developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris and listed on Euronext Paris (ticker: AB).

Further information is available on the AB Science website:
www.ab-science.com.

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For further information please contact:

Sciences AB
Financial Communication and Media Relations
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