AB Science announces the identification of a plasma biomarker that indicates the activity of masitinib in treating ALS
MWN-AI** Summary
AB Science has announced a significant breakthrough in the treatment of Amyotrophic Lateral Sclerosis (ALS) with the identification of a plasma biomarker that indicates the activity of masitinib, a potential therapeutic agent. This biomarker, derived from pro-inflammatory microglia, serves two notable functions: it detects the pathological activity related to the illness and can identify patients specifically targeted by masitinib. The biomarker demonstrates clear advantages, being blood-based for easy collection and evaluation through ELISA, enhancing its applicability in clinical settings.
Crucially, this biomarker is not limited to ALS but is also relevant for progressive forms of Multiple Sclerosis (MS) and Alzheimer’s Disease, making it a valuable tool for assessing treatment response in multiple neurodegenerative conditions. Professor Olivier Hermine, a prominent figure from AB Science's Scientific Committee, highlighted the biomarker's potential to inform treatment strategies across these diseases, underscoring its predictive capabilities regarding patient survival in ALS.
In laboratory tests, masitinib showed effectiveness in reducing levels of this biomarker, reinforcing its targeted action on mast cells and microglia, which are critical components in the inflammatory process associated with neurodegeneration. This development aligns with FDA guidance encouraging the integration of exploratory biomarkers into the drug development process for ALS, potentially paving the way for streamlined registration and approval of masitinib as a treatment option.
As AB Science prepares to introduce this biomarker into a Phase 3 clinical trial of masitinib, the company aims to validate its clinical relevance and enhance the odds of successful patient outcomes. Headquartered in Paris and listed on Euronext, AB Science continues to focus on high-unmet medical needs in its ongoing research and development initiatives.
MWN-AI** Analysis
AB Science’s recent announcement regarding the identification of a plasma biomarker linked to the efficacy of masitinib in treating Amyotrophic Lateral Sclerosis (ALS) is a significant development that could transform both the company’s market positioning and the treatment landscape for neurodegenerative diseases. The biomarker not only hints at masitinib’s mechanism of action but also shows promise for broader applications in progressive forms of multiple sclerosis and Alzheimer’s disease, potentially unlocking new revenue streams.
From an investment perspective, three key factors merit attention. First, the specificity of the biomarker allows for targeted treatment strategies that could enhance trial success rates. This aligns perfectly with regulatory leanings toward the use of biomarkers as surrogate endpoints, as noted in FDA guidance for ALS drugs. Investors should note that effective use of this biomarker in clinical trials might expedite its path to market approval, increasing masitinib's commercial viability.
Second, the dual potential for masitinib to address multiple debilitating conditions creates a unique value proposition. The pharmaceutical market for treatments targeting neurodegenerative diseases is substantial and underrepresented, indicating a lucrative opportunity for AB Science. As further clinical trials validate the biomarker’s role, it could attract partnerships or acquisition interest from larger pharmaceutical companies looking to bolster their neurology portfolios.
Lastly, AB Science’s strong commitment to unmet medical needs reinforces its strategic market position. However, investors should remain cautious of the inherent risks associated with clinical development, regulatory hurdles, and market competition.
In summary, while AB Science's identification of this biomarker presents a promising opportunity, careful monitoring of clinical developments and market dynamics is advised for any prospective investors looking to capitalize on this innovative advancement in neurobiology.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PRESS RELEASE
AB SCIENCE ANNOUNCES THE IDENTIFICATION OF A PLASMA BIOMARKER THAT INDICATES THE ACTIVITY OF MASITINIB IN TREATING AMYOTROPHIC LATERAL SCLEROSIS, AND THAT IS CAPABLE OF IDENTIFYING PATIENTS WITH PRO INFLAMATORY MICROGLIA, WHICH ARE TARGETED BY MASITINIB
THIS BIOMARKER IS ALSO APPLICABLE TO PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS AND ALZHEIMER DISEASE
THIS BIOMARKER CAN BE STRATEGIC TO DETERMINE WHICH PATIENTS RESPOND TO TREATMENT AND POTENTIALLY INCREASE CHANCE OF REGISTRATION IN NEURODEGENERATIVE DISEASES
Paris, February 24, 2026, 6pm CET
AB Science SA (Euronext - FR0010557264 - AB) announced the identification of a potential biomarker for assessing the activity of masitinib in pathological microglial involvement in Amyotrophic Lateral Sclerosis (ALS).
The key characteristics of this newly identified biomarker are as follows:
- It is a blood-based (plasmatic) biomarker, which has the advantages of being easy to collect and accurately evaluated using ELISA (enzyme-linked immunoassay).
- It is produced by proinflammatory microglia.
- It activates microglia and astrocytes and is therefore an activator contributing to a vicious neuroinflammation feedback loop.
- It is also released by mast cells, establishing a link between mast cells and microglia, which are two major cellular targets of masitinib.
- It is predictive of survival in ALS, potentially explaining why masitinib could extend survival in some specific patients.
- In-house experiments showed that this biomarker was reduced by masitinib when mast cells and microglia were activated in vitro, underscoring the specific and potent activity of masitinib on mast cells and microglia.
Professor Olivier Hermine, President of AB Science's Scientific Committee, member of the French Academy of Sciences and Head of the Hematology Department at Necker Hospital, commented: “Interestingly, this biomarker could be used in ALS but also in other neurodegenerative diseases of interest, namely progressive forms of multiple sclerosis (MS) and Alzheimer’s disease. In multiple sclerosis, for instance, this biomarker has normal plasmatic levels in clinically isolated syndrome (CIS), is elevated in RRMS during relapse, and is high in progressive forms, consistent with what we know about the involvement of microglia in MS”.
This biomarker will be introduced in the phase 3 program of masitinib in ALS, as well as in progressive MS and Alzheimer’s disease, to validate the mechanism of action of masitinib in humans and its clinical relevance. Once validated, it could facilitate registration by determining which patients respond best to treatment and serve as a surrogate endpoint of efficacy if necessary. Indeed, FDA Guidance on ALS states that “FDA encourages sponsors to incorporate exploratory biomarkers in all phases of development of ALS drugs. In the future, greater scientific understanding of ALS may provide opportunities for discussion of surrogate endpoints that are reasonably likely to predict clinical benefit and that might serve as a basis for accelerated approval.”
This biomarker remains undisclosed for patent protection reasons.
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 is key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, which are often lethal with short-term survival or rare or refractory to previous lines 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 being developed for human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. The company is headquartered in Paris, France and is 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, 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 uncertainties related to the 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 the 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 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
Attachment
FAQ**
How does the plasma biomarker identified by AB Science Paris Ord ABSCF specifically indicate the activity of masitinib in treating ALS, and what is the relevance of its correlation with proinflammatory microglia?
In what ways does AB Science Paris Ord ABSCF plan to utilize the identified biomarker to improve patient selection and treatment response in progressive forms of multiple sclerosis and Alzheimer’s disease?
What steps will AB Science Paris Ord ABSCF take to validate the clinical relevance of this plasma biomarker in the upcoming phase 3 program for masitinib, and how might it influence regulatory discussions with the FDA?
Can you elaborate on the potential implications of the identified biomarker serving as a surrogate endpoint of efficacy in clinical trials, and what challenges AB Science Paris Ord ABSCF might face in seeking regulatory approval?
**MWN-AI FAQ is based on asking OpenAI questions about Ab Science (OTC: ABSCF).
NASDAQ: ABSCF
ABSCF Trading
0.0% G/L:
$1.12 Last:
192 Volume:
$1.12 Open:
