IntelGenx Begins Phase 2 MONTPARK Trial of Montelukast VersaFilm

IntelGenx Begins Phase 2 MONTPARK Trial of Montelukast VersaFilm

By, Admin 10 April 2024

"IntelGenx begins patient dosing in phase 2 MONTPARK trial of Montelukast VersaFilm in patients with Parkinson’s disease

Overview

IntelGenx Corp. announced that Montelukast VersaFilm has been administered to the first Parkinson’s disease (PD) patients in the phase 2 (‘MONTPARK’) clinical trial.

MONTPARK 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.

Words from CEO: IntelGenx’s

  • “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.”

Parkinson’s Disease (PD)

  • 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. 
  • In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year. 
  • 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. 
  • Montelukast is a CysLT1 antagonist which decreases neuroinflammation by inhibiting CysLT1.

Montelukast & IntelGenx's

  • Montelukast was approved by the US Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. 
  • IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases, such as PD and AD, by re-formulating the drug into an oral film-based product. 
  • IntelGenx's proprietary VersaFilm technology is especially suited for special needs patient populations, and the Montelukast VersaFilm product offers many distinct advantages over tablets for PD and AD patients, including the avoidance and minimization of first-pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance.

Outcomes of Trial

  • In phase 1 studies, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. 
  • IntelGenx's oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.

IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

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