AB Science today announced the publication of the results of its positive study of masitinib in severe asthma not controlled by oral corticosteroids in the peer-reviewed Journal of Asthma and Allergy.

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PRESS RELEASE

AB SCIENCE ANNOUNCEMENT PUBLICATION IN THE ASTHMA AND ALLERGY DIARY POSITIVE MASITINIB PHASE 3 CLINICAL TRIAL RESULTS IN PATIENTS WITH SEVERE ASTHMA DEPENDING ON ORAL CORTICOSTEROIDS

Paris, seven June, 2022, 5.45pm HEC

AB Sciences SA (Euronext – FR0010557264 – AB) announces today the publication of the results of its positive study of masitinib in severe asthma not controlled by oral corticosteroids (OCS) in the peer-reviewed study Asthma and Allergy Diary [1].

This article, titled “Efficacy and Safety of Masitinib in Corticosteroid-Dependent Severe Asthma: A Randomized Controlled Trial” is freely available online at the journal’s website: https://www.dovepress.com/getfile.php?fileID=81290

Lavinia Davidescu, MD, professor of pulmonology at the University of Oradea, Romania, and coordinating researcher of the AB07015 study, said:Unlike other severe asthma drugs, masitinib innovatively targets the dual mechanism of mast cell-related asthma pathophysiology and PDGFR-related airway remodeling. Results this side phase 3 study have shown that severe steroid-dependent asthma patients treated with masitinib at 6.0 mg/kg/d had a lower risk of severe asthma exacerbations compared to those in a placebo control group that did not receive masitinib. The benefit of masitinib was too prove to be the most important in the most severely affected patients, that is to say those who required a higher cumulative dose of oral corticosteroids. The safety results of this study were consistent with the known profile of masitinib, with no new safety issuesindicating that mAsitinib may provide an effective new treatment option for severe asthma dependent on oral corticosteroids, including severe asthmatics who are ineligible to receive or fail registered biologic medications.”

Pascal Chanez, MD, professor of respiratory diseases at the University of Aix-Marseille, France, and lead author of this article commented: “Bbecause mast cells are more and more recognized to be involved in the pathophysiological processes that lead to exacerbations and structural changes in the airways in severe asthmatics, possibly through the modulation of steroid-insensitive pathways [2–8]youhere is a strong rationale for using masitinib, a selective mast cell inhibitor, as an add-on therapy in severe corticosteroid-dependent asthma. The results of this study show that oral masitinib has achieves key therapeutic goals for a medicine in severe asthma, both in terms of significantly reducing the rate of severe exacerbations and improving lung function, and notably does so through an entirely different mechanism than that associated with type 2 targeted biologics.”

Highlights of Study AB07015

The phase 3 study (AB07105) evaluating oral masitinib at 6 mg/kg/day compared to a placebo in severe asthma not controlled by oral corticosteroids (OCS) has reached its primary endpoint. Masitinib significantly reduced the rate of severe asthma exacerbations in patients with severe asthma not controlled by OCS.

The AB07015 study demonstrated efficacy in a difficult-to-treat population:

The primary analysis was conducted in the severe asthma population with a daily OCS ≥ 7.5 mg and masitinib treatment was associated with a significant reduction in severe asthma exacerbations by 35%, p=0, 0103 (annualized rate adjusted for overall treatment duration).
A pre-specified subgroup of severe asthmatic patients with elevated eosinophil counts (≥150 cells/μL) also demonstrated a statistically significant reduction in the rate of severe asthma exacerbations by 38%, p=0, 0156 (annualized rate adjusted for total duration of treatment) .
The benefit of masitinib was greater in patients who had higher cumulative OCS use (indicating more severe asthma that is more difficult to control) with a statistically significant reduction in the rate of severe asthma exacerbations of up to 71% for patients with a high eosinophil count (≥ 150 cells/μL) receiving an annualized cumulative intake of OCS > 1000 mg.
Additional sensitivity analysis using the ERS/ATS working group recommended the definition of severe exacerbations for clinical trials (i.e. an increase in the stable maintenance dose of OCS for at least 3 days, said increase being defined as a dose of at least 40 mg/day), showed that masitinib consistently and significantly reduced the rate of severe asthma exacerbations compared to placebo at all time points tested (total duration of treatment, weeks 36, 48, 52, 72 and 96).

The AB07015 study population was distinct from other asthma trials:

Patients were OCS dependent (100% receiving high dose OCS therapy) and no withdrawal
Patients in the primary analysis population were treated regardless of baseline eosinophil count
Evaluated over a long period (about 13 months)

Masitinib has a unique positioning in severe asthma, in terms of administration (oral administration), mechanism of action, target population and broader eosinophil count.

References

Davidescu L, Ursol G, Korzh O, et al. Efficacy and safety of masitinib in severe corticosteroid-dependent asthma: a randomized placebo-controlled trial. Asthma and Allergy Journal. Journal of Asthma and Allergy 2022: 15 737–747.
Penn RB. Mast cells in asthma: here I am, stuck in the middle with you. Eur Respir J. 2020;56(1):2001337.
Hinks TS, Levine SJ, Brussels GG. Treatment options in mild type 2 asthma. Eur Respir J. 2020.
Bradding P, Arthur G. Mast cells in asthma – state of the art. Clin Exp Allergy. 2016;46(2):194–263.
Balzar S, Fajt ML, Comhair SA, et al. Phenotype, localization and activation of mast cells in severe asthma. Data from the severe asthma research program. Am J Respir Crit Care Med. 2011;183(3):299–309.
Carter RJ, Bradding P. The role of mast cells in structural airway alterations as a potential mechanism in the pathogenesis of severe asthma. Curr Pharm Des. 2011;17(7):685–698.
Brightling CE, Bradding P, Symon FA, Holgate ST, Wardlaw AJ, Pavord ID. Mast cell infiltration of airway smooth muscle in asthma. N Engl J Med. 2002;346(22):1699-1705.
Maun HR, Jackman JK, Choy DF, et al. An Allosteric Anti-tryptase Antibody for the Treatment of Severe Mast Cell-Mediated Asthma Cell. 2019;179(2):417-431.e19.

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 is essential in signaling pathways within cells. . Our programs only target diseases with high unmet medical need, often fatal 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, is already 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, France, and is listed on Euronext Paris (ticker: AB).

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

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These forward-looking statements can often be identified by the words “expect”, “anticipate”, “believe”, “intend”, “estimate” or “plan”, and other similar terms. Although AB Science believes these forward-looking statements to be reasonable, investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties which are difficult to predict and generally beyond AB Science’s control and which may involve Actual results and events differ materially from those expressed, implied or anticipated in the forward-looking information and statements. These risks and uncertainties include uncertainties related to the development of the Company’s products which may not be successful or to the marketing authorizations granted by the competent authorities or, more generally, any factor that may affect the ability to market the products developed by AB Science, as well as those developed or identified in public documents published by AB Science. AB Science declines any obligation or commitment to update forward-looking information and statements, subject to applicable regulations, in particular articles 223-1 and following. of the general regulations of the AMF.

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