IntelGenx Corp (TSX:IGX)(OTCQB:IGXT) has finalized enrollment in its Phase 2a (“BUENA”) clinical trial for Montelukast VersaFilm®, a potential treatment for mild to moderate Alzheimer’s Disease (“AD”). IntelGenx is taking strides towards a potential landmark breakthrough for those suffering from AD, as the results of this trial could prove to be the much-needed breakthrough for this devastating condition.
IntelGenx recently enrolled 52 patients in a study, despite only having an initial plan for 70. Changes to the study design made to accommodate this were highly successful, with authorization to proceed being granted by a No Objection Letter (NOL) from Health Canada. To ensure accuracy when determining the drug effect size, the company consulted a statistical consultant, Cogstate Ltd., and agreed to adjust the p-value to p<0.1. Depending on the results, drug effect sizes of 0.6 or greater (0.5-<0.8 considered medium, 0.8+ considered large) may be determined to be statistically significant.
IntelGenx are passionate about advancing treatments for people suffering from Alzheimer’s Disease (AD), yet there remains a clear unmet medical need in this large and growing patient population. That’s why the company recently reduced the study enrolment required for the BUENA Trial – their trial to assess Montelukast VersaFilm® against a placebo – thereby helping to ensure that the program’s goal is achieved without further delay. Having gained approval from Health Canada for this study design modification, IntelGenx are aiming to complete the BUENA trial by the first quarter of 2024 and report initial trial results in the following quarter.
The Advanced Disease (AD) market is on track to reach heights of $13.7 billion by 2030, according to GlobalData. Such remarkable growth is attributed to both the large gaps in the market and new breakthrough drugs like Leqembi and donanemab. The compound annual growth rate of 20.0% from 2020-2030 will be especially prominent in the U.S., France, Germany, Italy, Spain, U.K., Japan, and China. With an estimated $2.2 billion value in 2020, the AD market is certainly heading in the right direction.
About Montelukast VersaFilm®
Montelukast, developed as an asthma and seasonal allergic rhinitis treatment and approved by the U.S. FDA in 1997, is now being investigated by IntelGenx for potential therapeutic use in treating neurodegenerative diseases. Using Montelukast combined with the company’s proprietary VersaFilm® technology, IntelGenx is looking to create an oral film-based product that would have distinct advantages over tablets when treating AD and Parkinson’s Disease – such as improved bioavailability, lower dosing and toxicity, and improved acceptance and compliance for special needs patient populations.
IntelGenx has made remarkable progress in its Phase 1 studies, proving that an oral film formulation of Montelukast is indeed safe and well-tolerated by healthy subjects. Moreover, its increased bioavailability of 52% compared to the regular Montelukast tablet makes it a far more attractive option, and the surprise bonus of it crossing the blood-brain barrier makes it indispensable for the treatment of degenerative brain diseases.
IntelGenx is a pioneering force in the world of drug delivery, bringing pharmaceuticals right to your doorstep with their top-of-the-line film-based medicine. Their world-class development and manufacturing processes ensure that no stone is left unturned when it comes to delivering safe and effective drugs to their consumers in the most practical and effective manner possible.
IntelGenx is pioneering the modern pharmaceutical market with their superior film technologies – VersaFilm®, DisinteQ™, VetaFilm®, and transdermal VevaDerm™. These groundbreaking developments are providing fast, effective solutions to address previously unmet medical needs. Patients and physicians alike are benefiting from IntelGenx’s pioneering product pipeline – a revolutionary approach to medical care that promises to revolutionize the world of healthcare.
IntelGenx’s team of highly qualified professionals provides comprehensive pharmaceutical services to its partners, ranging from R&D and analytical method development to clinical monitoring, IP, and regulatory services. But that’s not all; IntelGenx’s modern manufacturing facility offers an impressive scope of services, from lab-scale to full-scale commercial manufacturing. Beauty and brains? We think so.
Forward-Looking Information and Statements
As we look to the future, IntelGenx remains focused on achieving its goals and objectives. Though our journey is filled with potential risks and uncertainties, we are confident in our ability to rise to the occasion and capitalize on new opportunities.
We are committed to taking the necessary steps to ensure our success in both the US and Canadian markets, which includes adhering to all regulatory and securities filings with the Securities Exchange Commission of the US and Canadian securities regulatory authorities. Moving forward, IntelGenx will continue to take prudent measures, staying abreast of developments in the market and responding swiftly to any challenges that may arise.