Paris, 2 December 2014, 7.30 pm
Masitinib in Asthma - Summary of Web Conference
On-going phase 3 study in asthma uncontrolled by oral corticosteroid
successfully passes futility test
IDMC recommends continuation of phase 3 study based on
review of safety and efficacy data
AB Science will expand the asthma franchise by initiating
phase 3 study in a asthma uncontrolled by high-dose inhaled corticosteroid
and phase 2 in COPD, which target two much broader populations
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), provides a summary of the key points of the web conference held on 2nd December 2014 on masitinib in the treatment of asthma with key opinion leaders from this disease.
The current phase 3 study AB07015 in asthma uncontrolled by oral corticosteroid has recently been assessed as non futile by the Independent Data Safety and Monitoring Committee. A futility analysis tests the inability of a clinical study to achieve its efficacy objective, which in the present study is the frequency of severe asthma exacerbations. Hence, the conclusion of non futility suggests a clinical study is on track to achieve its stated efficacy objective. The study previously passed all reviews of safety data by the Independent Data Safety and Monitoring Committee. An interim analysis has been planned for this study.
Asthma uncontrolled by oral corticosteroid represents the most severe form of asthma (GINA step V patients that are uncontrolled) and represents a high unmet medical need. The quality of life of these patients is severely handicapped, with major reduction in lung function, restrictions on activities of daily living, work absenteeism, nighttime awakening several times a week, frequent exacerbations and greater risk of life-threatening asthma exacerbations. The target population in adult patients is estimated at 70,000 in the USA and in the EU.
In order to expand the asthma franchise, and following the non futility assessment of study AB07015 in asthma uncontrolled by oral corticosteroid, AB Science has decided to initiate a new phase 3 study in asthma uncontrolled by high-dose inhaled corticosteroid plus long-acting beta-agonists (LABAs). This new indication is much broader and is estimated to affect 1,500,000 adultes in the USA and Europe.
At this time, there is no drug registered in non allergic asthma uncontrolled by oral corticosteroid or by high-dose inhaled corticosteroid.
A phase 2 study in chronic obstructive pulmonary disease (COPD) has also been initiated. Although different, asthma and COPD are two converging diseases. COPD is currently the fifth-leading cause of death worldwide with still-growing prevalence, causing around 400,000 deaths in USA and EU in 2005, and with no satisfactory treatment available.
The safety database of masitinib is adequate to support registration in asthma uncontrolled by oral corticosteroid and asthma uncontrolled by high-dose inhaled corticosteroid. Indeed, the safety database presented will exceed guideline requirements for drugs intended for long-term treatment in non-life threatening disease, with over 1,500 patients exposed to masitinib, including over 600 patients (versus 300 required) treated for 6 months and over 300 patients (versus 100 required) treated for 12 months.
Intellectual Property for masitinib is secured in asthma until 2028, potentially until 2032. Patent protection on composition of matter for masitinib has been filed and delivered and will be extended until 2028 through patent tem extension (PTE). A further protection until 2028 has been achieved through a synthesis process patent already granted. In addition, further protection could be obtained until 2032 for the treatment of severe asthma through patents filed in 2012 after phase 2 results in asthma. Additional 6 months exclusivity can be granted in case on implementation of a pediatric investigation plan.
About masitinib
Masitinib 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 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 Science
Founded 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 in cancers, inflammatory diseases, and central nervous system diseases, both in human and animal health.
AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine in Europe and in the USA. The company is currently pursuing thirteen phase 3 studies in human medicine in first-line and second-line GIST, metastatic melanoma expressing JM mutation of c-Kit, multiple myeloma, metastatic colorectal cancer, metastatic prostate cancer, pancreatic cancer, mastocytosis, severe persistent asthma, rheumatoid arthritis, Alzheimer's disease, progressive forms of multiple sclerosis, and Amyotrophic Lateral Sclerosis. 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
This document contains prospective information. No guarantee can be given as for the realization of these forecasts, which are subject to those risks described in documents deposited by the Company to the Authority of the financial markets, including trends of the economic conjuncture, the financial markets and the markets on which AB Science is present.
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AB Science - Financial Communication & Media Relations
investors@ab-science.com
