IntelGenx Obtains Preliminary Efficacy Results for the ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
IntelGenx announced the preliminary efficacy results for its BUENA Phase 2a clinical trial evaluating Montelukast VersaFilm® in patients with mild to moderate Alzheimer’s disease (AD). The trial involved 59 participants, with 52 completing the 26-week treatment combining Montelukast buccal film with standard cholinesterase inhibitors. No overall cognitive improvement was observed compared to placebo. However, a significant cognitive benefit was noted in patients receiving at least 80% of the 30-mg twice-daily dose, with a benefit magnitude of d=0.5. The final comprehensive report is expected in Q3 2024.
According to Prof. Ludwig Aigner, these findings offer preliminary human evidence of Montelukast’s potential in treating AD, aligning with preclinical studies. The Alzheimer’s market is projected to grow significantly, reaching $13.7 billion by 2030.
- Patients receiving at least 80% of the 30-mg twice-daily dose of Montelukast showed significant cognitive improvement (d=0.5).
- The study provides preliminary human evidence supporting Montelukast as a potential treatment for Alzheimer’s disease.
- The Alzheimer’s market is expected to expand to $13.7 billion by 2030.
- No overall cognitive benefit was observed across all doses compared to placebo.
MONTREAL, July 03, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (the “Company” or “IntelGenx” a subsidiary of IntelGenx Technologies Corp.) (OTCQB: IGXT; TSX: IGX), 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
“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
About Montelukast VersaFilm®
Montelukast is a leukotriene receptor antagonist that was approved by the U.S. Food and Drug Administration 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.
About IntelGenx
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/ and connect with us on X and LinkedIn.
Forward-Looking Information and Statements
This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedarplus.ca. IntelGenx assumes no obligation to update any such forward-looking statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
FAQ
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