AB Science will present results from its Phase 3 AB07015 study in severe asthma at the 2020 American Thoracic Society Interna...

Paris, March 13 2020, 7.30am

AB Science to present results from its Phase 3 AB07015 study in severe asthma at the 2020 American Thoracic Society International Conference

Platform presentation will be included in a mini-symposium on Late Breaking Clinical Trials in Airway Diseases being held on Monday, May 18, 2020

AB Science SA (Euronext - FR0010557264 - AB) today announced that an abstract reporting results from its Phase 3 AB07015 study on severe asthma uncontrolled by oral corticosteroids (OCS), has been selected for oral platform presentation at the upcoming American Thoracic Society (ATS) 2020 International Conference in Philadelphia, USA (May 15-20, 2020).

Pascal Chanez, Professor of Respiratory Diseases at Aix-Marseille University, France, will present key data from the positive Phase 3 study, AB07015, as part of a mini symposium session entitled ‘Late Breaking Clinical Trials in Airway Diseases’.

ATS is one of the world’s largest meetings for pulmonary medicine professionals and has been historically well-attended by key opinion leaders and decision-makers in asthma research and healthcare policy.

Pascal Chanez said: “Selection of this abstract for a platform presentation on late-breaking clinical trials at the upcoming annual ATS Conference in Philadelphia is an indication of the clinical relevance of study AB07015 and masitinib potential impact on the treatment landscape for severe asthma”.

Olivier Hermine (President of the Scientific Committee of AB Science and member of the Académie des Sciences in France) said: “Unlike the biologic that are suited for patients with severe asthma associated with high eosinophils only, masitinib is effective regardless of the eosinophil level. This is due to its mechanism of action which is more global. Biologics targets eosinophils to reduce their quantity, whereas masitinib target mast cells which play a central role in asthma. In addition masitinib target PDGF receptor that seems to play a role in airway remodeling”.

Details for the presentation are as follows:

Presentation Title:       Masitinib Significantly Decreases the Rate of Asthma Exacerbations in Patients with Severe Asthma Uncontrolled by Oral Corticosteroids: A Phase 3 Multicenter StudySession Title:                 Mini Symposium on Late Breaking Clinical Trials in Airway Diseases (B93)Date/Time:                    Monday May 18, 2020 2:15 PM - 4:15 PM

Phase 3 study (AB07105) evaluating oral masitinib in severe asthma uncontrolled by oral corticosteroids met its primary endpoint. The pre-specified primary analysis was conducted in the severe asthma population with daily OCS ≥ 7.5 mg and masitinib treatment was associated with a significant reduction in severe asthma exacerbations (p=0.0103).

Detailed results will be presented during the conference. It is the policy of the ATS that all scientific research-related content included in an abstract to be presented at the ATS International Conference be withheld until after the abstract has been presented at the conference.

Masitinib has a unique positioning in severe asthma, in terms of administration (oral administration), mechanism of action, targeted population, and broad eosinophil level.

Masitinib is a first in class oral drug in severe asthma, selectively targeting mast cells through inhibition of tyrosine kinases c-Kit, LYN and FYN. There is a strong scientific rationale to target mast cells in asthma and study AB07015 was the first positive large-scale study in severe asthma utilizing a drug targeting mast cells [1]. Additionally, masitinib is a potent inhibitor of Platelet-Derived Growth Factor Receptor (PDGFR), which is associated with airway remodeling in asthma [2]. Masitinib is therefore capable of simultaneously modulating independent mechanisms of asthma pathophysiology, which is an attractive therapeutic strategy for severe asthma.

[1] Bradding P, Arthur G. Clin Exp Allergy. 2016 Feb;46(2):194-263.[2] Kardas G, et al. Front Pharmacol. 2020 Feb 14;11:47.

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.

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• ATS2020 AB07015 late-break VEng VF