The Phase IIa proof-of-concept trial is slated to begin screening patients in the first quarter of next year.
The 70-patient study is designed to evaluate the safety, feasibility, tolerability and efficacy of IntelGenx’s motelukast buccal film following daily dosing for 26 weeks.
IntelGenx is re-formulating montelukast as a therapy for neurodegenerative diseases using its VersaFilm oral film-based technology.
In a Phase I study, IntelGenx reported that the oral film formulation of montelukast was safe and tolerable in healthy participants and had a 52% higher bioavailability compared to a tablet formulation of montelukast. The oral film was also able to cross the blood-brain barrier, according to the Quebec-based company.
“There are limited treatments available for AD and, of those that are approved, none are disease modifying,” president & CEO Horst Zerbe said in prepared remarks. “A recent paper published in the journal, Immunity & Aging, noted that montelukast has been shown to rejuvenate aged brains in an animal model and suggested that this leukotriene receptor antagonist may have a similar effect in humans. We are very excited to commence this trial and evaluate the potential of montelukast as a much-needed treatment for AD patients.”