Masitinib Development Progress in Multiple Sclerosis Explored
Recent Advances in Masitinib for Multiple Sclerosis
AB Science SA today provided an exciting update regarding the progress of masitinib in treating progressive forms of multiple sclerosis (MS). This update follows the insights shared at the recent European Committee for Treatment and Research in Multiple Sclerosis conference. Masitinib, a notable compound from AB Science (PARIS:AB), is under examination for its potential effectiveness in managing this challenging neurological disease.
Understanding the MAXIMS Study
The development of masitinib is grounded in the MAXIMS study (AB20009). This robust, randomized, double-blind, phase 3 study investigates the effects of masitinib administered at a dosage of 4.5 mg/kg/day in patients diagnosed with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (nSPMS). To participate in this pivotal study, individuals must meet specific criteria, including an Expanded Disability Status Scale (EDSS) score between 3.0 and 6.0, a history of disease progression within the last two years, and no T1 Gadolinium-enhancing brain lesions.
Scientific Validation of Targeting Microglia
Significant findings were shared during the ECTRIMS 2024 conference, particularly those related to tolebrutinib, a drug that also targets microglia in nSPMS. This research bolsters the theory that microglial targeting could lead to meaningful advancements in MS treatment. Unlike tolebrutinib, which utilizes Bruton Tyrosine Kinase (BTK) for targeting microglia, masitinib employs a different approach through the Macrophage Colony Stimulating Factor Receptor-1 (M-CSFR1). This innovative targeting mechanism yielded positive results in a phase 2B study (AB07002), aligning well with tolebrutinib’s outcomes.
Study Results Highlighting Efficacy
The results from the AB07002 study indicate promising findings. For instance, EDSS progression confirmed at the three-month mark was reduced by 37% with masitinib, as compared to a 23% reduction seen with tolebrutinib in the Hercules study. Moreover, confirmed EDSS progression at six months showed a reduction of 32% with masitinib and 31% with tolebrutinib, suggesting masitinib’s robust efficacy.
Significant Improvements Observed
In addition to disability progression, masitinib demonstrated a significant improvement in manual dexterity as measured by the 9-hole peg test, showing promise with a p-value of 0.0388. Furthermore, research has indicated that masitinib can decrease serum neurofilament light chain (NfL) levels in animal models of MS, which could imply a reduction in neuronal damage.
Safety Profile and Long-Term Exposure
Masitinib comes with a well-documented safety profile, having been used extensively across various non-oncology indications. To date, approximately 2,200 patients have received at least one dose of masitinib, with over 1,300 having received the treatment for more than six months and nearly 1,000 for more than a year. This extensive experience contributes to the understanding of its safety and tolerability in the long term.
Conclusion and Future Perspectives
In summary, masitinib presents as a credible alternative to BTK inhibitors in the treatment arena for both primary and non-active secondary progressive MS. Professor Patrick Vermersch, MD, a pivotal figure in the MAXIMS study, remarked on the importance of the data presented regarding tolebrutinib, underscoring the potential for new therapeutic avenues in addressing the unmet medical needs presented by MS.
AB Science holds the commitment to advancing the scientific rationale for developing masitinib while corroborating the promising results achieved through the AB07002 study. By focusing on conditions with high unmet medical needs, the company emphasizes its dedication to enhancing patient outcomes.
Frequently Asked Questions
What is masitinib?
Masitinib is a protein kinase inhibitor being studied by AB Science for its efficacy in treating progressive forms of multiple sclerosis.
What is the MAXIMS study?
The MAXIMS study is a phase 3 clinical trial assessing the effectiveness of masitinib in patients with progressive forms of MS.
How does masitinib compare to tolebrutinib?
Both drugs target microglia but via different enzymatic routes, with masitinib focusing on the M-CSFR1 receptor.
What safety data is available for masitinib?
Masitinib has a significant safety database with over 2,200 patients treated, demonstrating long-term safety across various indications.
What are the next steps for AB Science?
AB Science plans to continue its research on masitinib, aiming to further validate its effectiveness in treating MS and addressing unmet medical needs in this space.
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