IntelGenx seeks Health Canada approval for montelukast VersaFilm trial
IntelGenx (OTCQX:IGXT; TSXV:IGX) submitted a clinical trial application to Health Canada for approval to initiate a Phase 2a proof-of-concept study with montelukast in mild-to-moderate Alzheimer's disease (AD).
The placebo-controlled trial 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 FDA in 1997 and has a very good safety profile.
In a recent Phase 1 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 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.
"This is IntelGenx's first ever Phase 2 study, and the CTA submission is a major milestone for our company and an important step in the repurposing of montelukast as a therapeutic to treat degenerative diseases of the brain," Dr. Horst Zerbe, president and CEO, said in a statement.
Final details of the Phase 2a clinical trial will be announced after it has been cleared by Health Canada.