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AB SCIENCE Receives Launch Approval from the U.S. Food and Drug Administration (FDA) The Phase 3 confirmatory study of macitinib in the treatment of progressive multiple sclerosis
Paris, December 29 2022, 6pm CET
AB Science SA (Euronext – FR0010557264 – AB) today announced that its Phase 3 clinical trial (AB20009) in advanced multiple sclerosis has been approved by the U.S. Food and Drug Administration (FDA).
This decision follows approvals received from several European countries, including the French Agency (ANSM).
This approval to initiate confirmatory neurological studies is the third approval received from the FDA, following studies in amyotrophic lateral sclerosis (AB19001) and Alzheimer’s disease (AB21004).
The AB20009 trial is actively recruiting patients. This is a randomized study to evaluate the safety and efficacy of macitinib 4.5 mg/kg/day in patients with primary progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (nSPMS) This is a double-blind Phase III trial.
This study will enroll 800 patients from multiple research centers with a Diastolic Disability Status Scale (EDSS) score of 3.0 to 6.0 and no T1 gadolinium-enhancing brain lesions. The primary endpoint of the study was the effect of macitinib on time to disease progression. The purpose of this trial is to confirm the positive results of the Phase 2B/3 trial (AB07002). 
Macitinib is positioned for progressive disease (PPMS or nSPMS). Currently, there is only one approved treatment for primary progressive disease and no approved treatment for inactive secondary progressive disease. It accounts for about 15% and 35% of MS cases, respectively, and about 500,000 patients in the US and Europe.
Macitinib targets microglia and mast cells, two cells of the innate immune system that are associated with the pathology of progressive multiple sclerosis. Macitinib’s mechanism of action is distinct from and potentially complementary to other tyrosine kinase inhibitors being developed in multiple sclerosis, such as BTK inhibitors that target B cells.
The principal investigator of the study, Professor Patrick Vermersch, Professor of Neurology at the University of Lille, France, said: “We are very pleased to receive FDA approval for this confirmatory study. this is Interest from health authorities Macitinib programs for progressive forms of multiple sclerosis and wider neurodegenerative disease,Also their understand That Macitinib have viable Neuroprotective role due to its mechanism of action. We believe this is backed up by scientific and clinical data.“.
 Vermersch P, Brieva-Ruiz L, Fox RJ, et al. Efficacy and safety of macitinib in progressive multiple sclerosis: a randomized phase 3 clinical trial. Neurol Neuroimmunol Neuroinflamm 2022;9:e1148. Doi: 10.1212/NXI.0000000000001148
About the results of the previous Phase 2B/3 study AB07002
Study AB07002 met its primary analytical endpoint, demonstrating a statistically significant reduction in cumulative change in EDSS with macitinib 4.5 mg/kg/day (p=0.0256). This treatment effect was consistent between PPMS and nSPMS. In addition, macitinib significantly reduced the risk of first failure progression by 42% and the risk of established (3-month) failure progression by 37%. Macitinib also significantly reduced the risk of reaching an EDSS score of 7.0. This corresponds to a disability severe enough to confine the patient to a wheelchair (p=0.0093). Product safety is consistent with macitinib’s known risk profile, with no increased risk of infection and may be superior to other agents used in multiple sclerosis, many of which High risk of sexual complications.
About multiple sclerosis
Multiple sclerosis is an autoimmune disease of the central nervous system and the leading cause of non-traumatic neuropathy in young and middle-aged adults. Multiple sclerosis affects about 2.5 million people worldwide, including more than 100,000 of her in France. It is characterized by the progressive deterioration of neurons in the central nervous system by the patient’s immune system, and mainly he has two forms.
Relapsing-remitting type It is characterized by disease recurrence. Relapsing-remitting multiple sclerosis includes secondary progressive active multiple sclerosis. During these relapses, patients experience the development of new symptoms or exacerbation of existing symptoms. These flare-ups are usually followed by recovery periods of variable length, after which some symptoms may persist. Relapsing-remitting multiple sclerosis is most often associated with dysfunction of adaptive immunity (B and T cells).
progressive form, characterized by constant and periodic exacerbations of disease symptoms without a clear relapse or recovery period. Progressive multiple sclerosis includes inactive secondary progressive multiple sclerosis. The incidence of severe, disabling and irreversible disability is much higher in the progressive form than in the relapsing remitting form. In progressive multiple sclerosis, innate immune cells such as macrophages, microglia and mast cells have been shown to probably play a major role.
High medical need in progressive multiple sclerosis
Patients with progressive multiple sclerosis have a shorter life expectancy than the general population. As neuropathy progresses and worsens since the onset of the disease, quality of life is significantly reduced, usually requiring wheelchair use for a large portion of the patient’s life. There is currently no cure for multiple sclerosis. Most of the registered therapies that affect the course of multiple sclerosis are effective only in relapsing forms of the disease (relapsing-remitting multiple sclerosis or active secondary progressive multiple sclerosis), Progressive multiple sclerosis (primary progressive multiple sclerosis or inactive secondary progressive multiple sclerosis). There is currently no approved treatment for the target population of studies AB07002 and AB20009, namely inactive progressive MS.
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 proteins that target key signaling pathways in cells. Our programs target only diseases with high unmet medical need. It is often fatal with short survival or is rare or refractory to previous therapies.
AB Science has developed a unique portfolio of molecules and its lead compound, macitinib, is already registered in veterinary medicine and is being developed in human medicine for oncology, neurological, inflammatory and viral diseases. I’m here. The company is headquartered in Paris, France and is listed on Euronext Paris (ticker: AB).
For more information, please visit the AB Science website.
Forward-Looking Statements – AB Science
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