IntelGenx updates Phase 2a Montelukast VersaFilm trial in AD
IntelGenx (TSXV:IGX; OTCQX:IGXT) updated its Phase 2a study of Montelukast VersaFilm in patients with mild-to-moderate Alzheimer’s disease (AD).
To date, seven study sites across Canada have randomized eight subjects, many of which began dosing in late-2018. Study sites are actively screening for new patients and IntelGenx expects enrollment to accelerate following the holiday season hiatus.
In addition to opening its planned eighth trial site, IntelGenx is preparing to open an additional site in Montreal, bringing the total number of sites to nine.
“Although in its early stages, this is an exciting trial for IntelGenx as we work with our study sites to achieve a shared goal of finding a treatment that benefits patients living with this most unfortunate and debilitating disease,” Dr. Horst Zerbe, president and CEO, said in a statement.
Unlike traditional dosage forms, Montelukast VersaFilm is engineered to deliver montelukast with an improved bioavailability, which may be more efficacious than other montelukast dosage forms in crossing the blood-brain barrier.
“As a result, our VersaFilm technology has the potential to be broadly applicable to a wide variety of other pharmaceutical treatment options,” he added.
IntelGenx’s Phase 2a proof-of-concept study will enroll approximately 70 subjects with mild-to-moderate AD. The study will evaluate the safety, feasibility, tolerability, and efficacy of montelukast buccal film following daily dosing for 26 weeks.