Montelukast formulation to be tested in Swedish Parkinson’s study
18-month effort will assess medication in doses exceeding 40 mg
IntelGenx has finalized a research grant agreement with Karolinska University Hospital, Sweden for a placebo-controlled clinical study of Montelukast VersaFilm, an experimental oral thin film formulation for Parkinson’s disease.
Manufacturing of both the treatment and its placebo are underway ahead of the study, which will be led by Per Svenningsson, MD, PhD, a Parkinson’s expert at Karolinska University Hospital.
“Prof. Svenningsson’s interest in evaluating Montelukast VersaFilm for the treatment of [Parkinson’s disease] reflects his confidence in the drug’s therapeutic potential,” Dwight Gorham, IntelGenx’s CEO, said in a press release.
Parkinson’s disease is a progressive neurodegenerative disorder marked by the loss of dopamine-producing neurons in the brain.
Inflammation is a contributing factor in Parkinson’s progression. When the brain’s immune cells become overactive, they can promote neuronal damage, contributing to dopaminergic neurons’ degeneration.
What are the benefits of VersaFilm over oral tablets?
Montelukast (brand name Singulair) is used for asthma and allergies. Mainly available as oral tablets, it blocks the action of leukotrienes, chemicals that cause inflammation, easing symptoms.
Because it can reduce inflammation, it’s thought it may also treat neurological diseases marked by inflammation in the brain such as Parkinson’s and Alzheimer’s disease.
IntelGenx’s VersaFilm technology provides several unique benefits over tablets, including reduced first-pass effects (the changes that a medicine undergoes in the body before it reaches the blood), easy administration, increased bioavailability, lower dosage and toxicity, enhanced acceptability, and improved compliance.
In Phase 1 testing, Montelukast VersaFilm was found safe and well tolerated in healthy people. The formulation, which dissolves directly in the mouth, showed 52% higher bioavailability over tablets.
It was also able to cross the blood-brain barrier, a semi-permeable membrane that prevents medications from entering the brain. This is an important feature for a medication being tested for neurological diseases.
In an earlier clinical study (EudraCT 2020-000148-76) of 15 people with Parkinson’s, Svenningsson’s team showed that montelukast oral tablets were safe and well tolerated when given twice daily for a total dose of 40 mg for 12 weeks, or three months.
“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,” Gorham said.
In the new study, participants will be randomly assigned to receive either Montelukast VersaFilm or a placebo for 18 months, or about 1.5 years.
Svenningsson will sponsor the study with a 20 million Swedish crown grant (about $2 million) from the Swedish Research Council, a governmental research funding body.
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