IntelGenx Announces Research Collaboration with Renowned Neurologist
Friday, February 10, 2023
IntelGenx Corp announced a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomised, double-blind, placebo-controlled clinical study (the “Study”) to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”).
Montelukast is a leukotriene receptor antagonist 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 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 Alzheimer’s Disease and PD patients, including the avoidance and minimisation 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.
After completion of the Study, IntelGenx will retain the intellectual property rights and use the findings to further develop Montelukast VersaFilm® programme for Parkinson's disease treatment. The Study is currently expected to commence in the third quarter of 2023.
It is believed that Montelukast VersaFilm® has the potential to be disease-modifying, not only in AD, but also currently investigated in the Phase 2a ‘BUENA’ clinical trial.
