IntelGenx (TSX:IGX; OTCQB:IGXT) finalized a research grant agreement with Sweden’s Karolinska University Hospital and that the manufacturing of both active and placebo films are underway for a planned multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of IntelGenx’s Montelukast VersaFilm for the treatment of Parkinson’s disease (PD).
The study will be conducted at the Karolinska University Hospital under IntelGenx’s previously announced research collaboration with Per Svenningsson, M.D., Ph.D., who will serve as the study’s principal investigator.
Dr. Svenningsson, a Professor of clinical neuroscience who investigates the pathogenic mechanisms of PD, previously conducted a clinical study utilizing the tablet form of montelukast for the treatment of PD, where 2 tablets of 10 mg montelukast were administered twice daily, for a total daily dose of 40 mg.
“Prof. Svenningsson’s interest in evaluating Montelukast VersaFilm for the treatment of PD reflects his confidence in the drug’s therapeutic potential, which is based on findings from his earlier montelukast tablet study, the higher bioavailability of our film formulation, as well as the need for a more convenient dosing method,” Dwight Gorham, IntelGenx’s CEO, said in a statement.
“As the planned study will assess montelukast in doses exceeding 40 mg, Montelukast VersaFilm offers study participants an attractive dosing alternative to tablets, which would require administration of multiple tablets several times per day,” he added.
Prof. Svenningsson will sponsor the study through a 20 million Swedish Crowns grant, or about $2-million (U.S.), awarded by the Swedish Research Council, Sweden’s largest governmental research funding body.
On completion of the study, IntelGenx will have the option to acquire the developed intellectual property rights and study data for a predetermined low five-digit amount and use the findings to further develop its Montelukast VersaFilm program for the treatment of PD.
