IntelGenx Submits Canadian Clinical Trial Application

IntelGenx (TSXV:IGX; OTCQX:IGXT) announced it submitted a clinical trial application to Health Canada for approval to start its Phase 2a proof of concept study with Montelukast in mild to moderate Alzheimer’s Disease.
As quoted in the press release:

The study, entitled “A randomized Phase IIa, multi-center, double-blind, placebo-controlled study to assess the safety, feasibility, tolerability, and efficacy of a new buccal film of Montelukast in patients with mild to moderate Alzheimer’s Disease,” is to be conducted at eight study sites, and will measure several safety and efficacy endpoints following daily dosing for 26 weeks.
IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. Currently, Montelukast is marketed as Singulair, a once daily tablet for the chronic treatment of asthma and seasonal allergic rhinitis. The drug was first approved by the U.S. Food and Drug Administarion in 1997 and has a very good safety profile. IntelGenx’ proprietary VersaFilm™ technology offers several potential advantages over the tablet form of Montelukast, including the avoidance and minimization of first-pass-effects, improved API bioavailability, lower dosing and toxicity, easier swallowing and better patience compliance.

Click here to read the full press release.

Source: www.marketwired.com