Canada-based oral drug delivery firm IntelGenx is set to initiate a Phase IIa clinical trial of Montelukast VersaFilm in the first quarter of next year for patients with Alzheimer’s disease (AD).

The move follows Health Canada’s clearance for the firm’s clinical trial application to treat mild-to-moderate AD.

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Montelukast was originally approved in 1997 by the US Food and Drug Administration (FDA) to treat asthma and seasonal allergic rhinitis.

The firm is currently working towards re-formulating the medicine into an oral film-based therapeutic for treating neurodegenerative diseases.

According to IntelGenx, Montelukast VersaFilm has various advantages such as a decrease in first-pass-effects, easy administration, low dosing and toxicity and improved compliance, compared to tablets.

The randomised, double-blind, placebo-controlled proof-of-concept Phase IIa trial is planned to include around 70 patients at eight sites in Canada.

“There are limited treatments available for AD and, of those that are approved, none are disease modifying.”

Primary objectives of the trial are safety, feasibility, tolerability, and efficacy of Montelukast buccal film after daily dosing for 26 weeks.

IntelGenx president and CEO Dr Horst Zerbe said: “There are limited treatments available for AD and, of those that are approved, none are disease modifying.

“We are very excited to commence this trial and evaluate the potential of Montelukast as a much-needed treatment for AD patients.”

An oral film formulation of Montelukast is reported to have been safe and tolerable during a Phase I trial in healthy participants.

Montelukast further demonstrated 52% higher bioavailability, when compared with the regular Montelukast tablet, and was observed to cross the blood-brain barrier.