AB Science secures European patent for masitinib in severe mastocytosis treatment until 2036

Paris, May 13, 2024 – AB Science SA has revealed that the European patent office has granted a new patent for methods of treating severe mastocytosis with its leading compound, masitinib. This patent (EP 3359195A1) secures intellectual property rights until October 2036, adding to the protection already established in the USA (US 10045978B2) and Japan (JP 6801892B2).

Masitinib is targeted as a treatment for patients suffering from severely symptomatic systemic mastocytosis, including subtypes like indolent and smoldering systemic mastocytosis, who do not respond well to optimal symptomatic treatments. The new patent specifically protects masitinib and related compounds for treating systemic mastocytosis in patients exhibiting at least two severe symptoms associated with mast cell mediator release, such as pruritus, flushing, or depression.

The patented treatment strategy aligns with the outcomes of masitinib study AB06006 and supports the ongoing clinical development program for severe systemic mastocytosis. Additionally, masitinib has been granted orphan drug designation for mastocytosis by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), providing 10 and 7 years of market exclusivity in Europe and the United States, respectively, upon product approval.

AB Science has also implemented a similar patent strategy for other conditions. For instance, worldwide patents for amyotrophic lateral sclerosis have been granted until 2037. The company is also pursuing patents for multiple sclerosis and Alzheimer’s disease, aiming for protection until 2041, and in prostate cancer until 2042.

Indolent systemic mastocytosis (ISM) is a hematological disorder characterized by an excessive number and activation of mast cells in the bone marrow and other organs. ISM manifests through various debilitating and sometimes life-threatening symptoms, predominantly affecting neurological functions (e.g., depression, fatigue, cognitive impairment, headaches), skin (e.g., pruritus, skin lesions), flushing, and gastrointestinal issues. ISM affects approximately 40,000 individuals in Europe and 25,000 in the USA, highlighting a significant unmet medical need.

Masitinib is an orally administered tyrosine kinase inhibitor targeting mast cells and macrophages, which are crucial for immune responses. By inhibiting a select number of kinases, masitinib's unique mechanism of action allows it to be developed for a wide range of conditions, including oncological, inflammatory, and central nervous system diseases. In oncology, masitinib can enhance survival rates either alone or in combination with chemotherapy. Its action on mast cells and microglia helps inhibit inflammatory processes, potentially alleviating symptoms and slowing the progression of inflammatory and central nervous system disorders.

Founded in 2001, AB Science is a pharmaceutical company dedicated to the research, development, and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins essential for intracellular signaling pathways. The company's development programs focus on diseases with high unmet medical needs, often characterized by poor prognosis or resistance to previous treatments.

AB Science has developed a proprietary portfolio of molecules, with masitinib as its lead compound. Masitinib has been approved for veterinary use and is under development for human medicine in areas such as oncology, neurological diseases, inflammatory conditions, and viral infections. AB Science is headquartered in Paris, France, and is listed on Euronext Paris (ticker: AB).

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