Phase 2 trial of montelukast oral film starts dosing
Study tests treatment's effectiveness in Parkinson's
The first patients received doses of an oral thin-film formulation of montelukast in a clinical trial testing the treatment’s potential for Parkinson’s disease.
The placebo-controlled MONTPARK trial will test how well a high dose of Montelukast VersaFilm, a proprietary formulation being developed by IntelGenx, can slow the progression of early- to moderate-stage Parkinson’s, a disease thought to be driven in part by brain inflammation.
“Dosing of the first [Parkinson’s] patients in the Phase 2 MONTPARK trial represents a major milestone in the clinical development of Montelukast VersaFilm,” Dwight Gorham, IntelGenx’s CEO, said in a company press release.
MONTPARK (EudraCT 2023-504278-39-00), expected to enroll as many as 90 patients, is running at the Karolinska University Hospital and three other sites in Sweden under a research collaboration with Per Svenningsson, MD, PhD, the trial’s lead principal investigator.
Participants will be given 30 mg of Montelukast VersaFilm or a placebo twice daily for 18 months.
Crossing the blood-brain barrier
Montelukast, sold as Singulair with generics available as oral and chewable tablets and granules to take by mouth, is used to treat asthma and allergy. It works by blocking the action of cysteinyl leukotriene receptor 1 (CysLT1), a known mediator of inflammation, including brain inflammation.
Because it can reduce inflammation and cross the blood–brain barrier, a barrier that prevents harmful substances from entering the brain and spinal cord, montelukast could ease symptoms of neurodegenerative diseases marked by inflammation, such as Parkinson’s.
In an earlier open-label clinical trial (EudraCT 2020-000148-76) in 15 Parkinson’s patients with a median age 65, montelukast oral tablets were safe and well tolerated when given twice daily for a total dose of 40 mg for 12 weeks.
Patients in the MONTPARK trial will be randomly assigned to receive either a placebo or Montelukast VersaFilm, a formulation that’s designed to make the medication easier to take and absorb better. This means patients can take lower doses with potentially fewer side effects.
Eligible patients must be on levodopa, the mainstay of treatment for Parkinson’s, at the time of enrollment. They may also be on other medications that work to mimic the activity of dopamine, a signaling chemical that’s involved in motor control and is gradually lost in Parkinson’s.
Montelukast VersaFilm is also being tested for the treatment of mild to moderate Alzheimer’s disease, another neurodegenerative disease, in an ongoing Phase 2 clinical trial called BUENA (NCT03402503).
“As treatment options for neurodegenerative diseases like PD [Parkinson’s disease] and AD [Alzheimer’s disease] 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,” Gorham said.
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