IntelGenx Receives Health Canada Clearance to Begin Phase 2a Study with Montelukast Versafilm(TM) in Mild to Moderate Alzheimer's Disease

SAINT-LAURENT, QUEBEC--(Marketwired - Dec. 15, 2017) - IntelGenx Corp. (TSX VENTURE:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx") is pleased to announce that Health Canada has cleared the clinical trial application for its Montelukast VersaFilm™ intended for the treatment of mild to moderate Alzheimer's disease ("AD"). The phase 2a proof of concept ("POC") clinical study will start screening AD patients in Q1 2018.

This randomized, double-blind, placebo controlled Phase 2a POC study will enroll approximately 70 subjects with mild to moderate AD 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.

"There are limited treatments available for AD and, of those that are approved, none are disease modifying," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "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."

IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. Montelukast has been approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx' proprietary VersaFilm™ technology is especially suited for special needs patient populations, and the Montelukast VersaFilm™ product therefore offers many distinct advantages over tablets for AD 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 I 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' oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.