IntelGenx to test its montelukast oral film for Parkinson’s

Results of the trial will be used to advance VersaFilm clinical program

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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IntelGenx has teamed up with a renowned neurologist at the Karolinska Institute, Sweden to conduct a clinical trial on Montelukast VersaFilm, its proprietary oral thin film formulation, in people with Parkinson’s disease.

The multicenter trial, expected to start between July and September, will be led by Per Svenningsson, MD, PhD, a Parkinson’s expert. The neurologist will sponsor the study with a 20 million Swedish crown grant (about $2 million) from the Swedish Research Council, the country’s largest governmental research funding body.

“Dr. Svenningsson is professor of Clinical Neuroscience at the Karolinska Institute and investigates [disease-associated] mechanisms of PD [Parkinson’s disease],” said Horst G. Zerbe, PhD, the CEO of IntelGenx, in a company press release. “He has previously conducted a clinical study utilizing the tablet form of montelukast in the treatment of PD, and we are excited that he will be leading this new clinical study with our proprietary oral film formulation of the drug.”

Trial participants will be randomly assigned to receive either montelukast VersaFilm or a placebo film for 18 months, or about 1.5 years. Both the therapy and the placebo will be supplied by IntelGenx, which will use the results to advance its montelukast VersaFilm clinical program for Parkinson’s.

Parkinson’s is marked by the progressive death of neurons, or nerve cells, that produce dopamine — a chemical messenger essential for muscle control.

Levodopa, a precursor to dopamine, has long been one of the gold standards for treating Parkinson’s. No neuroprotective or disease-modifying treatments are currently available, however.

Excessive inflammation has been implicated in Parkinson’s and other neurological disorders, and a number of studies in patients and animal models support modulating the immune system as a potential therapeutic approach.

Montelukast, sold as Singulair and with generics available, is available in oral tablets, chewable tablets, and oral granules for treating asthma and seasonal allergic rhinitis. Approved for use in the U.S. and Europe since 1998, it works by blocking the cysteinyl leukotriene receptor 1 (CysLT1), a known mediator of inflammation, including in the brain.

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Montelukast to treat neuroinflammation

The therapy can cross the blood-brain barrier, the highly selective permeable membrane that prevents microbes and potentially harmful molecules in circulation from entering the brain and spinal cord. This is an essential feature for therapies designed for diseases of the brain and/or spinal cord.

As such, montelukast could also be used to treat neurological conditions marked by neuroinflammation, such as Parkinson’s and Alzheimer’s disease, and early results have supported its therapeutic potential for such neurodegenerative disorders.

IntelGenx is working on an oral film formulation of montelukast that doesn’t require water. It was created with VersaFilm, the company’s proprietary oral thin film technology.

Montelukast VersaFilm is easier to administer than oral tablets and the film allows for increased medication concentration at target sites because it bypasses the body’s initial clearance of swallowed therapies.

By being absorbed into the bloodstream directly from the mouth, montelukast VersaFilm avoids being cleared by the liver before making its way through the body. This allows for lower doses and reduced toxicity.

“We believe that Montelukast VersaFilm has the potential to be disease-modifying, not only in [Alzheimer’s disease], as is being currently investigated in the Phase 2a ‘BUENA’ clinical trial, but also in PD,” Zerbe said.

The Canadian BUENA study (NCT03402503) has begun dosing mild to moderate Alzheimer’s patients with either montelukast VersaFilm or a placebo film, once or twice daily for six months.