AB Science today announced publication of results from its positive study of masitinib in severe asthma uncontrolled by oral corticosteroids in the peer-reviewed Journal of Asthma and Allergy
08 June 2022 - 1:45AM
PRESS RELEASE
AB SCIENCE ANNOUNCES
PUBLICATION IN THE
JOURNAL OF ASTHMA AND ALLERGY OF POSITIVE
MASITINIB PHASE 3 CLINICAL
TRIAL RESULTS IN
PATIENTS WITH ORAL
CORTICOSTEROID-DEPENDENT SEVERE ASTHMA
Paris, 7 June, 2022, 5.45pm CET
AB Science SA (Euronext -
FR0010557264 - AB) today announced publication of results from its
positive study of masitinib in severe asthma uncontrolled by oral
corticosteroids (OCS) in the peer-reviewed Journal of Asthma and
Allergy [1].
This article, titled ‘Efficacy and Safety of Masitinib in
Corticosteroid-Dependent Severe Asthma: A Randomized Controlled
Trial’ is freely accessible online from the journal website:
https://www.dovepress.com/getfile.php?fileID=81290
Lavinia Davidescu, MD, Professor of Pulmonology
at the University of Oradea, Romania, and coordinating investigator
of study AB07015, said: “Unlike other drugs for severe asthma,
masitinib innovatively targets the dual mechanisms of mast
cell-related asthma pathophysiology and PDGFR-related airway
remodeling. Results from this phase 3 study showed that
corticosteroid-dependent severe asthma patients treated with
masitinib at 6.0 mg/kg/d had a lower risk of severe asthma
exacerbations compared with those in a placebo-control group that
did not receive masitinib. Benefit of masitinib was also shown to
be greatest in the most severely affected patients, that is to say,
those who required a higher cumulative oral corticosteroid dose.
Safety results from this study were consistent with the known
profile for masitinib, with no new safety concerns, indicating that
masitinib may provide a new effective treatment option for oral
corticosteroid-dependent severe asthma, including severe asthmatics
that are ineligible to receive or in failure to registered
biologics.”
Pascal Chanez, MD, Professor of Respiratory
Diseases at Aix-Marseille University, France, and senior author of
this article commented: “Because mast cells are increasingly
recognized as being involved in pathophysiological processes that
drive exacerbations and structural changes of the airway in severe
asthmatics, possibly through modulation of steroid insensitive
pathways [2–8], there is a strong rationale to use masitinib, a
selective mast cell inhibitor, as an adjunct therapy in
corticosteroid-dependent severe asthma. Results from this study
show that oral masitinib has achieved the main therapeutic
objectives for a drug in severe asthma, both in terms of
significant reduction in the rate of severe exacerbations and
improved pulmonary function, and notably does so through an
entirely different mechanism to that which is associated with
Type-2 targeted biologics.”
Study AB07015 highlights
Phase 3 study (AB07105) evaluating oral
masitinib at 6 mg/kg/d versus placebo in severe asthma uncontrolled
by oral corticosteroids (OCS) met its primary endpoint. Masitinib
significantly decreased the rate of severe asthma exacerbations in
patients with severe asthma uncontrolled by OCS.
Study AB07015 demonstrated efficacy in a difficult to treat
population:
- 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 of 35%, p=0.0103 (annualized rate adjusted for
the overall time on treatment).
- A pre-specified subgroup of severe
asthma patients with high eosinophil counts (≥ 150 cells/μL) also
demonstrated a statistically significant reduction in rate of
severe asthma exacerbations of 38%, p=0.0156 (annualized rate
adjusted for the overall time on treatment).
- Benefit of masitinib was greatest
in patients who had higher cumulated use of OCS (indicative of more
severe asthma that is harder to control) with statistically
significant reduction in rate of severe asthma exacerbations of up
to 71% for patients with high eosinophil counts (≥ 150 cells/μL)
receiving an annualized cumulative OCS intake of >1000 mg.
- Additional sensitivity analysis
using the ERS/ATS task force recommended definition of severe
exacerbations for clinical trials (i.e., an increase in stable
maintenance dose of OCS for at least 3 days, wherein said increase
was defined as a dose of at least 40 mg/day), showed that masitinib
consistently and significantly reduced rate of severe asthma
exacerbations relative to placebo across all time points tested
(overall time on treatment, weeks 36, 48, 52, 72, and 96).
Study AB07015 population was distinct from other
asthma trials:
- Patients were dependent on OCS (100%
receiving high dose OCS therapy) and no weaning
- Patients in the primary analysis
population were treated irrespective of baseline eosinophil
count
- Evaluated over a long period of time
(approx. 13 months)
Masitinib has a unique positioning in severe
asthma, in terms of administration (oral administration), mechanism
of action, targeted population, and broader eosinophil level.
References
- Davidescu L, Ursol G, Korzh O, et
al. Efficacy and Safety of Masitinib in Corticosteroid-Dependent
Severe Asthma: A Randomized Placebo-Controlled Trial. Journal of
Asthma and Allergy. 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, Brusselle GG.
Treatment options in type-2 low 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. Mast cell phenotype, location, and activation 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 the structural alterations of the airways 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 Mast
Cell-Mediated Severe 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 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.
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