IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm in Phase 2 ‘MONTPARK’ Clinical Trial

SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.

MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, 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 VersaFilm 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. MONTPARK is being conducted at the Karolinska University Hospital and at three other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who is serving as the study’s Lead Principal Investigator.

“Dosing of the first PD patients in the Phase 2 MONTPARK trial represents a major milestone in the clinical development of Montelukast VersaFilm, which is also being investigated for the treatment of mild to moderate Alzheimer’s Disease, or AD, in the ongoing ‘BUENA’ Phase 2a study,” said Dwight Gorham, IntelGenx’s CEO. “As treatment options for neurodegenerative diseases like PD and AD remain limited, with studies such as MONTPARK and BUENA, we are taking significant steps closer to providing patients with a novel, disease-modifying treatment that also offers a dosing method that is especially suited to their needs.”

About Parkinson’s Disease

PD is the second most common neurodegenerative disease after AD, with an estimated 9 million patients globally and 1 million patients in the United States.^1,2 In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year.² 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.³ Montelukast is a CysLT₁ antagonist which decreases neuroinflammation by inhibiting CysLT₁.