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IntelGenx gets green light to launch Ph2 Alzheimer’s study in Canada

December 15, 2017 By Sarah Faulkner

IntelGenxIntelGenx (CVE:IGX) said today that Health Canada approved its application to study its montelukast VersaFilm therapy in adults with mild to moderate Alzheimer’s disease.

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.”

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Filed Under: Clinical Trials, Featured, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: IntelGenx

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