In This Article:
PRESS RELEASE
AB SCIENCE PROVIDES AN UPDATE ON ITS MASITINIB PLATFORM
Paris, January 29, 2025, 7pm CET
AB Science SA (Euronext - FR0010557264 - AB) today provides an update on its masitinib platform. The webcast presentation is available on the company’s website, in the section « Press Releases »: https://www.ab-science.com/news-and-media/press-releases/
Highlights of the presentation are the following:
Amyotrophic lateral sclerosis
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New confirmatory study AB23005 simplified for enrolment and targeting best responders for masitinib will be initiated in line with recommendation of FDA and EMA
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Design validated by FDA and EMA
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Confirmatory study authorized by FDA
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Pathway to registration secured with agencies
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Discussion with partners facilitated
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First study AB10015 generated strong hypothesis on patients normal progressor and prior to any complete loss of function with significant +12 months survival
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Long term follow-up shows 53% of patients surviving more than 5 years, with a +36 months benefit over ENCALS prediction
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Some patients survived from 10 to 15 years and continue to take treatment
Progressive Forms of Multiple Sclerosis
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Mechanism of action targeting microglia reinforced after the success of a BTK inhibitor which also targets microglia
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Targeting mast cells adds to the efficacy since mast cells activate microglia and directly acts on myelin degradation
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Masitinib Hazard Ratio of EDSS progression compared with BTK inhibitor Hazard Ratio published shows that masitinib is competitive, even if the populations are not comparable and the comparison is indirect
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KOLs are very supportive of masitinib program
Alzheimer’s Disease
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Targeting the innate immune reaction stands out in addition to main strategy with biologics aimed at reducing beta amyloid or Tau protein plaques
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Masitinib is the only drug that generated positive results in moderate Alzheimer’s Disease
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Masitinib could be combined with biologics in early and mild Alzheimer’s Disease
More globally
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The failure of multiple programs for decades reinforces the value of masitinib approach to target the innate immune reaction through modulation of microglia and mast cells
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The unmet medical need in those three indications is immense
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The markets are huge with potential sales exceeding billions in each indication
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Masitinib IP rights are secured through use patent until 2037 in ALS and up to 2041 in MS and AD, and by orphan drug status in ALS and data protection of 10 years in Europe and 8 years in the USA
Negotiation with banks
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AB Science has a debt of 3.7M€ related to PGE (Prêt Garanti par l’Etat) and intends to negotiate a stand-still clause
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Current resources should be allocated to R&D program exclusively