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
- New confirmatory study AB23005 simplified for enrolment and targeting best responders for masitinib will be initiated in line with recommendation of FDA and EMA
- Design validated by FDA and EMA
- Confirmatory study authorized by FDA
- Pathway to registration secured with agencies
- Discussion with partners facilitated
- First study AB10015 generated strong hypothesis on patients normal progressor and prior to any complete loss of function with significant +12 months survival
- Long term follow-up shows 53% of patients surviving more than 5 years, with a +36 months benefit over ENCALS prediction
- Some patients survived from 10 to 15 years and continue to take treatment
Progressive Forms of Multiple Sclerosis
- Mechanism of action targeting microglia reinforced after the success of a BTK inhibitor which also targets microglia
- Targeting mast cells adds to the efficacy since mast cells activate microglia and directly acts on myelin degradation
- 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
- KOLs are very supportive of masitinib program
Alzheimer’s Disease
- Targeting the innate immune reaction stands out in addition to main strategy with biologics aimed at reducing beta amyloid or Tau protein plaques
- Masitinib is the only drug that generated positive results in moderate Alzheimer’s Disease
- Masitinib could be combined with biologics in early and mild Alzheimer’s Disease
More globally
- 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
- The unmet medical need in those three indications is immense
- The markets are huge with potential sales exceeding billions in each indication
- 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
- AB Science has a debt of 3.7M€ related to PGE (Prêt Garanti par l’Etat) and intends to negotiate a stand-still clause
- Current resources should be allocated to R&D program exclusively
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:
www.ab-science.com.
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
[email protected]
Attachment
- CP Masitinib Update 28012025 VENG VF
