SAINT LAURENT, Quebec, Jan. 23, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a leading oral drug delivery company, today provided an update on its Phase 2a study of Montelukast VersaFilm(TM) in patients with mild to moderate Alzheimer's Disease (AD).
To date, seven study sites across Canada have randomized eight subjects, many of which commenced dosing in late-2018. IntelGenx sponsored 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.
"We are looking forward to commencing patient recruitment at our eighth site in the coming weeks, as well as opening an additional site in Montreal by the end of first quarter 2019," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "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."
"Unlike traditional dosage forms, our Montelukast VersaFilm(TM) is engineered to deliver Montelukast with an improved bioavailability, which may be more efficacious than known Montelukast dosage forms in crossing the blood-brain barrier," contends Dr. Zerbe. "As a result, our VersaFilm(TM) technology has the potential to be broadly applicable to a wide variety of other pharmaceutical treatment options."
The randomized, double-blind, placebo-controlled 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.
About Montelukast VersaFilm(TM)
Montelukast is a leukotriene receptor antagonist that was 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(TM) technology is especially suited for special needs patient populations, and the Montelukast VersaFilm(TM) product offers many distinct advantages over tablets for Alzheimer'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 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 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.
