Paris, October 10, 2019, 8am
AB Science provides update on masitinib programs timelines
Company is on track to announce data in severe asthma and in MS in 4Q 2019
AB Science SA (NYSE Euronext – FR0010557264 – AB) today provides an update on the expected timelines for the read-outs from its Phase 2/3 masitinib clinical programs. The Company remains on track to announce data on masitinib in severe asthma uncontrolled by oral corticosteroids and in progressive primary and secondary MS in Q4 2019.
The timelines for the final analyses for each study are summarize below:
- Q4 2019: Severe asthma uncontrolled with oral corticosteroids (study AB07015)
- Q4 2019 : Progressive primary and secondary multiple sclerosis (study AB07002)
- Q4 2019 / Q1 2020 : Alzheimer’s Disease (study AB09004)
- Q2 2020 : Severe asthma uncontrolled with inhaled corticosteroids (study AB14001)
- 2020 : Pancreatic cancer (study AB12005)
- 2020 : Metastatic prostate cancer (study AB12003)
The timing for the analyses of the pancreatic and prostate cancer studies remains unchanged, with results from both expected during 2020. The expected date of final analysis is still an estimate, and will be dependent on how quickly the number of planned events in each of these the clinical trial is reached. Results for study AB14001 in asthma (uncontrolled with inhaled corticosteroids) are estimated to be available in Q2 2020. Result for study AB09004 in Alzheimer’s disease are estimated to be available by year-end 2019 or Q1 2020.
To date, the databases for each of these studies remain unlocked and none of the results are available to AB Science. The revised timelines are later than previous estimated timelines communicated in July 2019, as a result of the procedures that have been implemented under the company’s new quality control system. These procedures are designed to ensure that a database lock will only occur once all quality controls have been performed. Certain steps of these quality controls require communication with the clinical sites and the timing of resolution is not always under the control of AB Science.
Alain Moussy, CEO and co-founder of AB Science stated “We are closing three studies, that together have enrolled approximately 1,800 patients, at around the same time. We are following the rigorous datalock process implemented under our new quality control system. The timing of the final analyses for certain studies is later than previously expected. We are eager to have these results and plan to communicate the study outcomes as soon as they are available, beginning with the results in severe asthma and then progressive primary and secondary multiple sclerosis.”
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 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 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.
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 Science
This 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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