Enrollment reaches halfway in IntelGenx Phase 2a Montelukast VersaFilm AD trial

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Patient enrollment in the IntelGenx (TSX:IGX; OTCQB:IGXT) ongoing Montelukast VersaFilm Phase 2a BUENA clinical trial in patients with mild-to-moderate Alzheimer’s disease (AD) has reached the halfway mark.

This proof-of-concept study currently includes six clinical research sites with the potential of adding two more sites in the coming month, all of which are expected to enroll a total of approximately 70 patients.

“We are encouraged by the speed with which AD patients are enrolling in this trial following the resumption of our recruiting efforts,” Dr. Horst Zerbe, CEO of IntelGenx, said in a statement. “We continue to work diligently to improve the recruitment rate even further, and anticipate completing enrollment before the end of 2022.”

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.