AB Science : Presents Phase 2B/3 Study Results in Progressive Multiple Sclerosis at the World's Largest Multiple Sclerosis Research Conference

Paris, September 14, 2020, 7am

Press release

AB Science Presents Phase 2B/3 Study Results in Progressive Multiple Sclerosis at the World's Largest Multiple Sclerosis Research Conference

• 50% of patients suffering from multiple sclerosis have one of the progressive forms of the disease, for which there is no satisfactory treatment to date
   
• Masitinib, a tyrosine kinase inhibitor developed by AB Science, provides the first clinical evidence that targeting the innate immune system is an effective strategy for the treatment of progressive forms of multiple sclerosis.

AB Science SA (Euronext - FR0010557264 - AB), a pharmaceutical company specialized on the research, development and commercialization of protein kinase inhibitors (PKIs), announced today that it has presented the world's first key results from its Phase 2B/3 study (AB07002) evaluating its lead product, masitinib, in both progressive forms of multiple sclerosis¹ during the 8^th Joint Meeting of the European (ECTRIMS) and American (ACTRIMS) Committees for Treatment and Research in Multiple Sclerosis (MS). The congress was held in virtual format this year (MSVirtual2020) due to the COVID-19 pandemic.

Presented by Patrick Vermersch (MD, PhD), Professor of Neurology at the University of Lille, France, principal coordinator of study AB07002 and a recognized expert in multiple sclerosis, the results of this study demonstrate, for the first time, the efficacy of a therapeutic product in the treatment of patients suffering from both progressive forms of multiple sclerosis.

"These results are the start of a possible revolution in the treatment of multiple sclerosis, as it is the first time a treatment has shown efficacy in both progressive forms of this pathology," commented Professor Patrick Vermersch. "To date, there is no treatment capable of effectively targeting the cells that play a major role in the evolution of the progressive forms of multiple sclerosis. In addition, masitinib can be administered on a long-term basis as it is not an immunosuppressive treatment, which is particularly important in patients who are to receive long-term treatment and who, for some, have already an immune system weakened by previous treatments or because of their age. I am looking forward to continuing the development of this product and to seeing the realization of new therapeutic hope for these patients.”

A strong medical need for the progressive forms of multiple sclerosis

Multiple Sclerosis is an autoimmune disease of the central nervous system that affects more than 100,000 people in France and for which no definitive treatment exists to date. It is characterized by a progressive degradation of the nerve cells of the central nervous system by the patient's immune system and comes in two main forms.

The relapsing-remitting form characterized by relapses of the disease. During these relapses, patients experience the onset of new symptoms or the worsening of symptoms already present. These flare-ups are usually followed by recovery periods of varying length, after which some symptoms may persist. The relapsing-remitting forms of multiple sclerosis are mostly associated with dysfunctions of adaptive immunity² (B cells and T cells).

The progressive form, characterized by a constant and regular worsening of the symptoms of the disease, without a distinct relapse or period of recovery. The rate of onset of severe, disabling, and irreversible disability is much higher in the progressive forms of the disease than in the relapsing remitting forms. In progressive multiple sclerosis, innate³ immune cells such as macrophages, microglia or mast cells have been shown to probably play a major role.

To date, the vast majority of treatments for the management of multiple sclerosis target the patient's adaptive immune system and therefore apply mainly to the relapsing remitting forms of the disease. However, patients suffering from a progressive form of the disease currently account for approximately 50% of MS cases.

Masitinib: first drug in the world to demonstrate a significant effect on progressive forms of multiple sclerosis

AB Science's lead product, masitinib, is an oral tyrosine kinase inhibitor that specifically targets the innate immunity of patients with multiple sclerosis. In the Phase 2B/3 study, AB07002, conducted in 301 patients, masitinib at a dose of 4.5 mg/kg/day slowed disease progression in patients, which was the study’s primary objective. Masitinib also demonstrated a significant reduction in the risk of reaching a level of disability severe enough to require wheelchair mobility.

"With this conclusive study, AB Science is now on the verge of becoming the first biotech company in the world to propose a new approach for the treatment of progressive forms of multiple sclerosis. We will of course continue the development of this product and will as soon as possible initiate the process to start a confirmatory study, a necessary step to definitively validate the therapeutic potential of masitinib in a broader population" concludes Professor Olivier Hermine, Chairman of the Scientific Committee of AB Science and member of the French Academy of Sciences.

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

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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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¹ Primary Progressive Multiple Sclerosis (PPMS) and Non-active Secondary Progressive Multiple Sclerosis (nSPMS)

² Adaptive immunity corresponds to the immune protection that an individual builds over the course of his or her life according to the pathogens to which his or her organism is exposed.

³ An individual's innate immunity represents his immune protection from birth.

Attachment

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