IntelGenx Corp. announced that the Swedish Medical Products Agency, the Swedish Ethical Review Authority, and the Regional Biobank Centre have approved the planned clinical study to investigate the use of IntelGenx's Montelukast VersaFilm for the treatment of Parkinson's Disease. PD is the second most common neurodegenerative disease after Alzheimer's disease, with an estimated 9 million patients globally and 1 million patients in the United States.

In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year. No neuroprotective or disease-modifying treatments are currently available. The current standard treatment of PD motor dysfunction is based on the enhancement of dopaminergic transmission and involves the administration of L-dopa.

Evidence from multiple patient studies and animal models has shown a significant immune component during the course of the disease, highlighting immunomodulation as a potential treatment strategy. Montelukast is a CysLT1 antagonist which decreases neuroinflammation by inhibiting CysLT1. Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and Alzheimer's Disease.

The Phase 2 MONTPARK study (CT number 2023-504278-39-00) is a randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD. The study will enroll up to 90 patients who will receive 30 mg Montelukast Versa film®? or placebo twice daily for 18-months, followed by a 3-month washout period.

Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents.