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AB Science will present new data from masitinib clinical program in ALS in two presentations at the 2025 ENCALS Annual Meeting

By: AB Science via GlobeNewswire

May 05, 2025 at 12:03 PM EDT

PRESS RELEASE

AB SCIENCE TO PRESENT NEW DATA FROM MASITINIB CLINICAL PROGRAM IN AMYOTROPHIC LATERAL SCLEROSIS IN TWO PRESENTATIONS AT THE 2025 ENCALS ANNUAL MEETING

MASITINIB REDUCES SERUM NEUROFILAMENT LIGHT CHAIN (NFL) LEVELS, SUGGESTING THAT IT HAS DISEASE-MODIFYING POTENTIAL

CLINICAL BENEFIT, INCLUDING CAFS AND SURVIVAL, IS GREATEST IN A SUBGROUP OF ALS PATIENTS THAT SERVES AS THE BASIS FOR THE RECENTLY AUTHORIZED PHASE 3 CONFIRMATORY STUDY

Paris, May 5, 2025, 6pm CET

AB Science SA (Euronext - FR0010557264 - AB) today announced that new analyses from its phase 3 trial in amyotrophic lateral sclerosis (AB10015) and preclinical animal model data have been accepted for presentation at the ENCALS annual meeting (June 3-6, 2025, Turin, Italy). ENCALS is the European network to cure amyotrophic lateral sclerosis (ALS), with abstracts selected by the Scientific Program Committee based on scientific quality.

Professor Albert Ludolph, MD, PhD, commented “These two new abstracts provide valuable data further supporting the potential for masitinib’s new phase 3 study to confirm its efficacy based on clinical endpoints and biomarkers such as NfL.”

Professor Albert Ludolph, MD, PhD, (Chairman of the Department of Neurology at the University Hospital and Medical Faculty of Ulm), will deliver a poster presentation entitled ‘Masitinib subgroup analysis in patients prior to complete loss of function, shows increased benefit across endpoints, including survival’.

Subgroup analyses were performed within the cohort defined as ‘ALS prior to any complete loss of function’ (i.e., score ≥1 on each of the ALSFRS-R items), thereby eliminating from baseline any potential confounding zero-item score bias. This is compatible with the mechanism of action of masitinib since masitinib is a disease modifier but is not designed to regenerate motoneurons. Clinical data from the above defined subgroup showed a strong benefit in terms of treatment effect magnitude and consistency across endpoints, in particular on CAFS and a +12-month benefit in survival, thereby supporting the concept that a phase 3 confirmatory study should be performed in ALS patients prior to any complete loss of function.

Professor Hayrettin Tumani, MD, PhD, (Head of Laboratory for CSF Diagnostics and Clinical Neurochemistry, Ulm, Germany) will deliver a poster presentation entitled ‘Masitinib limits neuronal damage measured by NfL in a model of neuroimmune-driven neurodegenerative disease’.

Using a model closely aligned with masitinib's mechanism of action in inflammatory neurodegenerative diseases, masitinib has been shown to reduce serum neurofilament light chain (NfL) levels, thereby decreasing the rate of neuronal damage. Given that chronic neuroinflammation is a hallmark of most neurodegenerative diseases, the observed NfL treatment response suggests that masitinib possess a disease-modifying potential in ALS.

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
investors@ab-science.com

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