Montelukast VersaFilm® Administered in Phase 2 Parkinson's Trial

IntelGenx Corp. recently announced the initiation of a Phase 2 clinical trial, named MONTPARK, involving the administration of Montelukast VersaFilm® to Parkinson's Disease (PD) patients. This trial is designed to investigate the efficacy of high-dose oral Montelukast in slowing disease progression in early-to-moderate PD stages. The study, identified under the EudraCT number 2023-504278-39-00, is randomized, double-blind, placebo-controlled, and will include up to 90 participants. They will receive 30 mg of Montelukast VersaFilm® or a placebo twice daily for 18 months followed by a three-month washout period. Participants must be undergoing levodopa treatment and may be using other symptomatic dopaminergic agents. The trial is conducted at Karolinska University Hospital and three additional Swedish institutions with Dr. Per Svenningsson leading as the Principal Investigator.

Dwight Gorham, CEO of IntelGenx, emphasized the significance of dosing the first PD patients in this trial, marking a crucial step in Montelukast VersaFilm®'s clinical pathway. This drug is also under investigation for mild to moderate Alzheimer’s Disease (AD) in an ongoing Phase 2a study named BUENA. Gorham highlighted the necessity for new treatments for neurodegenerative diseases like PD and AD, reinforcing the company’s commitment to innovative therapeutic solutions with simplified administration methods tailored to patient needs.

Parkinson’s Disease is the second most prevalent neurodegenerative condition after Alzheimer’s Disease, affecting approximately nine million people globally and one million in the United States. Each year, around 90,000 new cases are diagnosed in the US. Currently, no treatments exist that can modify or protect against the disease. The standard PD treatment focuses on enhancing dopaminergic transmission, mainly through levodopa administration. Research has shown a considerable immune component in the disease’s progression, which positions immunomodulation as a potential therapeutic strategy. Montelukast, a CysLT1 antagonist, can reduce neuroinflammation by inhibiting CysLT1, which opens up possibilities for its repurposing in neurodegenerative diseases.

Originally approved by the U.S. Food and Drug Administration in 1997 for asthma and allergic rhinitis, Montelukast is being re-formulated into an oral film using IntelGenx’s proprietary VersaFilm® technology. This method offers significant advantages such as reduced first-pass effects, simplified administration, improved drug bioavailability, lower toxicity and dosing, and better patient compliance compared to tablets. In Phase 1 studies, Montelukast administered through this oral film demonstrated safety and tolerability, showcased a 52% higher bioavailability than the tablet form, and effectively crossed the blood-brain barrier, crucial for treating brain degenerative disorders.

IntelGenx specializes in advanced drug delivery methods, developing pharmaceutical films that address unmet medical needs through technologies such as VersaFilm®, DisinteQ™, VetaFilm®, and VevaDerm™. The company provides extensive pharmaceutical services, including R&D, clinical monitoring, and regulatory assistance, with its manufacturing facility catering to both pilot and commercial-scale production.