IntelGenx has announced preliminary efficacy results from its Phase IIa BUENA clinical trial, evaluating Montelukast (MTK) in adults with mild to moderate Alzheimer’s disease (AD).
The proof-of-concept (PoC) BUENA study assessed the cognitive improvements in AD patients using different doses of Montelukast (MTK) alongside standard cholinesterase inhibitors.
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It enrolled 59 adult patients, with 52 completing 26 weeks of treatment.
Cognitive function was measured using a series of tests developed by Cogstate.
While the final study report is expected in the third quarter of 2024, the topline analysis revealed that, overall, no general cognition benefit was observed across all MTK doses compared to placebo.
However, a separate analysis for each dose indicated a significant improvement in cognition among patients who consistently received the 30mg twice-daily dosage of MTK, with a magnitude of benefit measured at d=0.5.
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By GlobalDataInitially approved by the US Food and Drug Administration (FDA) in 1997, Montelukast, a leukotriene receptor antagonist, is indicated for asthma and seasonal allergic rhinitis.
It is being repurposed by IntelGenx for neuroinflammatory and neurodegenerative diseases.
The company is re-formulating the drug into an oral film-based product.
The Montelukast VersaFilm product is believed to offer numerous benefits for AD and Parkinson’s disease patients, including ease of administration, improved bioavailability of the active pharmaceutical ingredient (API), reduced dosing and toxicity, and enhanced patient compliance.
Cogstate chief innovation officer Paul Maruff said: “Given the relatively small sample size and the mild to moderate clinical disease severity of the study sample, interpretation of the results should be based on consideration of the treatment effect observed on the composite neuropsychological measure of cognition.
“This preliminary analysis suggests that treatment with MTK 30mg twice daily, based on the ‘per treatment’ analyses (treatment compilers), was associated with an experimentally important benefit to cognition. Given this, further study of this 30mg MTK twice-daily dose with consistent treatment will be of value.”
