IntelGenx Completes Enrollment for BUENA Montelukast VersaFilm Phase 2a Clinical Trial in Patients With Mild-to-Moderate Alzheimer’s Disease

IntelGenx Corp. recently announced it has completed patient enrollment in the ongoing Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with mild-to-moderate Alzheimer’s Disease (AD).

The company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a No Objection Letter (NOL) from Health Canada. The NOL provided authorization to proceed with the study changes. IntelGenx, in consultation with its statistical consultant, Cogstate Ltd., determined that adjusting the p-value (which determines whether a drug effect exists) to p<0.1 will provide a basis for determining the extent to which effect sizes (the size of the drug effect) of 0.6 or greater (0.5 to <0.8 are considered “medium” effect sizes, while 0.8 or greater are considered “large” effect sizes) are statistically significant.

“While there have been exciting recent advancements in the treatment of AD, there is no question that significant unmet medical need remains in this large and growing patient population,” said Dwight Gorham, IntelGenx’s CEO. “As the COVID-19 pandemic effectively halted the BUENA trial’s recruitment for approximately 18 months, followed by imposed post-pandemic restrictions from hospitals, our rationale behind decreasing study enrollment was to avoid any further delay in achieving the program’s goal. We are confident that this Health Canada-authorized study design modification will enable us to utilize data from fewer patients while optimizing the power of the study to detect the effects of Montelukast VersaFilm compared to placebo. We are looking forward to completing the BUENA trial in the first quarter of 2024 and to reporting initial trial results the following quarter.”

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% 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 Leqembi and donanemab, which is expected to be approved by year-end.

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 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.

In Phase 1 studies, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx’s oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.

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 pharmaceuticals 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 www.intelgenx.com.