IntelGenx Obtains Preliminary Efficacy Results for the BUENA Montelukast VersaFilm Phase 2a Clinical Trial in Patients With Mild to Moderate Alzheimer’s Disease

IntelGenx Corp. has successfully completed the BUENA Alzheimer’s disease (AD) study. The BUENA study was designed as a Phase 2a proof of concept study to investigate the extent to which different doses of Montelukast (MTK) could improve cognition in adults with AD as well as to provide information on the safety and tolerance of the buccal film in this patient group. The BUENA study enrolled 59 adults with mild to moderate severity AD, of which 52 completed 26 weeks treatment with “standard of care” cholinesterase inhibitors and Montelukast buccal film (10mg per day or 30mg twice daily) or cholinesterase inhibitors and placebo. Cognition was assessed using a battery of neuropsychological tests developed by Cogstate, a neuroscience company focused on optimizing cognitive assessment in clinical trials.

Although the final study report, which includes the analysis of all safety and efficacy information, is planned for completion and release at the beginning of third quarter 2024, IntelGenx has obtained the outcome of a topline analysis of the efficacy data from the BUENA study.

The summary study results indicated that when considered across all doses of MTK, no benefit to general cognition was observed when compared to change under placebo. However, when the data from the neuropsychological tests was analysed separately for each dose, adults with AD who received at least 80% of 30-mg twice-daily doses of MTK showed a statistically significant improvement in general cognition compared to placebo with the benefit being d= 0.5 in magnitude.

“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,” said Paul Maruff, PhD, Chief Innovation Officer at Cogstate. “This preliminary analysis suggests that treatment with MTK 30-mg twice-daily, based on the ‘per treatment’ analyses (treatment compliers), was associated with an experimentally important benefit to cognition. Given this, further study of this 30-mg MTK twice-daily dose with consistent treatment will be of value.”

Prof. Ludwig Aigner (head of the Institute of Molecular Regenerative Medicine at Paracelsus Medical University in Salzburg, Austria) our key scientific drug development partner, has over the years contributed to the IntelGenx’s MTK program, and established and published preclinical evidence of the use of MTK in neuroinflammatory and neurodegenerative diseases, including in AD transgenic mice. Prof. Aigner was quite pleased that the BUENA study has provided some first human evidence – although preliminary – for the use of MTK buccal film as a treatment modality and option for patients with mild to moderate AD, which seems to suggest that neuroinflammation could play a role in the pathogenesis of AD and potentially other neurodegenerative diseases.

GlobalData recently reported that the AD market is expected to reach $13.7 billion in 2030 across the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and China), representing a compound annual growth rate of 20.0% from $2.2 billion in 2020. The expansion is primarily attributed to the significant unmet needs posed by AD, combined with the introduction of new therapies, including the recently approved monoclonal antibody therapies.

Montelukast is a leukotriene receptor antagonist that was approved by the US FDA in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neuroinflammatory and neurodegenerative diseases by re-formulating the drug into an oral film-based product. IntelGenx’s proprietary VersaFilm technology is especially suited for special needs patient populations, and the Montelukast VersaFilm product offers many distinct advantages over tablets for AD and Parkinson’s Disease patients, including the avoidance and minimization of first-pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance.

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm, DisinteQ, VetaFilm and transdermal VevaDerm, allow for next-generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx’s highly skilled team provides comprehensive pharmaceutical services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit https://www.intelgenx.com/.