IntelGenx (TSX:IGX; OTCQB:IGXT) intends to resume patient screening in the ongoing Montelukast VersaFilm Phase 2a BUENA clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) following Health Canada’s issuance of a “no objection letter” in response to the company’s amended clinical trial application.
In the first quarter of 2020, IntelGenx received Health Canada authorization to proceed with an amended BUENA clinical trial protocol and continue the trial at an increased daily dose.
However, because the target study population in the BUENA study is considered to be a higher risk group for severe illness from COVID-19, and out of concern for the health and safety of clinical trial staff, IntelGenx informed Health Canada in the second quarter of 2020 that the study was on a temporary recruitment hold.
The no objection letter now paves the way for patient screening to resume in October 2021 under the amended protocol.
“As treatment options remain limited, and no approved drugs are disease modifying, we are very excited to resume this trial and evaluate the potential of
Montelukast as a much-needed treatment for AD patients,” Dr. Horst Zerbe, CEO of IntelGenx, said in a statement.
“We are in the fortunate position that the convertible notes offering that closed in the third quarter of 2001 provided us with the dedicated financial resources required to complete this important study, and expect to resume patient screening activities as soon as practicable this month,” he added.
Montelukast is a leukotriene receptor antagonist that was approved by the FDA in 1997 for the treatment of asthma and seasonal allergic rhinitis.
In Phase 1 studies, 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.