AB Science announced that it has received new authorizations to resume patient enrollment in its Phase 3 studies of masitinib
PRESS RELEASE
AB SCIENCE ANNOUNCES THAT IT HAS RECEIVED NEW AUTHORIZATIONS TO RESUME PATIENT ENROLLMENT IN ITS PHASE 3 STUDIES OF MASITINIB, CONFIRMING A GLOBAL RESUMPTION OF THESE STUDIES
Paris, September 14 2021, 6pm CET
AB Science SA (Euronext - FR0010557264 - AB) announced today that it has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) to resume patient enrollment in the confirmatory Phase 3 study of masitinib (AB19001) in amyotrophic lateral sclerosis, and also authorization from the UK (MRHA) and Dutch (CCMO) National Agencies of Medicine in the confirmatory Phase 3 study of masitinib (AB15003) in mastocytosis.
These authorizations follow the validation in July 2021 by the ANSM [1] of the measures proposed by AB Science to reinforce patient safety related to cardiac risk in its ongoing studies.
These authorizations follow those already received from European agencies [2], in amyotrophic lateral sclerosis (Norway) and in mastocytosis (France), and confirm a global resumption of these studies.
[1] Press release dated July 12, 2021
[2] Press releases of August 23, 2021 and August 25, 2021
About amyotrophic lateral sclerosis
Amyotrophic lateral sclerosis (ALS) is a fatal motor neuron disorder that is characterized by progressive loss of the upper and lower motor neurons at the spinal or bulbar level. The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die, and stop sending messages to muscles.
The prevalence of ALS in western countries is fairly uniform at 6 per 100,000 persons, corresponding to around 30,000 cases in Europe and 20,000 in the USA.
The first drug treatment for ALS, riluzole (Rilutek), was approved in 1995. In Europe, there has been no new treatment approved since riluzole.
About indolent systemic mastocytosis
Indolent systemic mastocytosis (ISM) is a hematological disease characterized by an abnormal number and activation of mast cells in the bone marrow and other organs. The disease if characterized by multiple symptoms that are disabling and can in some cases be life-threatening. Symptoms associated ISM are predominantly associated with neurological disorders (depression, fatigue, cognitive impairment, headache), skin disorders (pruritus, skin lesions), flushing and gastro-intestinal disorders. ISM affects approximately 40,000 people in Europe and 25,000 in the USA. There is currently no therapy approved for the treatment of ISM.
About masitinib
Masitinib is a 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, 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:
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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 published by AB Science. 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.
For additional information, please contact:
AB Science
Financial Communication & Media Relations
Media Relations – USA
RooneyPartners
Kate Barrette
+1 646 432 0191
Media Relations – France
NewCap
Arthur Rouillé
+33 (0)1 44 71 00 15
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