IntelGenx (OTCQX:IGXT; TSXV:IGX) has initiated the Phase 2a proof-of- concept clinical trial with its Montelukast VersaFilm in Alzheimer’s disease patients, following clearance by Health Canada.
The Phase 2a trial is a randomized, double-blind, placebo controlled study that will enroll approximately 70 subjects with mild-to-moderate Alzheimer’s disease across eight Canadian research sites. The primary study objectives will be to evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily dosing for 26 weeks.
IntelGenx has retained the services of Cogstate and JSS Medical Research as the contract research organizations to support the Montelukast VersaFilm study. Patient screening is expected to begin before the end of the current first quarter.
“Current treatments for Alzheimer’s disease are limited,” Dr. Horst Zerbe, president and CEO of IntelGenx, said in a statement. “Accordingly, we believe that Montelukast has the potential to be a true game-changer and are very excited to commence this trial.”
IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. The FDA approved Montelukast in 1997 for the treatment of asthma and seasonal allergic rhinitis.
In a recent Phase 1 study, 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 with 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.
