Health Canada has cleared IntelGenx’s (OTCQX:IGXT; TSXV:IGX) 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 clinical study will start screening AD patients in the first quarter of 2018. The study will enroll about 70 subjects with mild-to-moderate AD at 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," Dr. Horst Zerbe, president and CEO, said in a statement.
"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,” he added.
IntelGenx is repurposing Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. The FDA approved Montelukast in 1997 for the treatment of asthma and seasonal allergic rhinitis.
The Montelukast VersaFilm product has the potential to offer 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 1 study, IntelGenx demonstrated that an oral film formulation of Montelukast was safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability, compared with 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.