montelukast VersaFilm (INT0043) / IntelGenx - LARVOL DELTA

Multi-center, randomized, open-label, positive drug parallel control, non-inferiority clinical trial of the efficacy and safety of montelukast oral film in the treatment of childhood asthma (ChiCTR) - P4 | N=458 | Not yet recruiting | Sponsor: Shanghai Children's Hospital, Fudan University; Shanghai Children's Hospital, Fudan University

Head-to-Head • New P4 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

MONTELUKAST DOSE-DEPENDENTLY IMPROVES GLOBAL COGNITION IN THE BUENA STUDY: A RANDOMIZED PHASE IIA "PROOF-OF-CONCEPT" STUDY IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE (ADPD 2025) - P2 | "However, among patients who received at least 80% of the study drug (i.e. treatment compliers) the 2 x 30 mg MTK treatment group showed a significant improvement in global cognition relative to placebo and the 10 mg MTK treatment group. Conclusions Given the large significant effect in improvement in global cognition observed in treatment complying participants receiving 2 x 30 mg MTK as well as the safety profile observed after 26 weeks of treatment, a further study with the 2 x 30 mg MTK treatment is warranted."

Clinical • P2a data • Alzheimer's Disease • CNS Disorders

Preparation and In Vitro Evaluation of Montelukast Sodium-Loaded 3D Printed Orodispersible Films for the Treatment of Asthma. (PubMed, AAPS PharmSciTech) - "It was concluded that the formulations did not show toxic potential by in vitro cytotoxicity study with 3T3 cells. This new formulation can efficiently treat allergic rhinitis and asthma diseases."

Journal • Preclinical • Allergic Rhinitis • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

IntelGenx Obtains Preliminary Efficacy Results for the ‘BUENA’ Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease (GlobeNewswire) - P2 | N=52 | BUENA (NCT03402503) | Sponsor: IntelGenx Corp. | "IntelGenx Corp...has successfully completed the BUENA Alzheimer’s disease (AD) study....Although the final study report, which includes the analysis of all safety and efficacy information, is planned for completion and release at the beginning of third quarter 2024, IntelGenx has obtained the outcome of a topline analysis of the efficacy data from the BUENA study. The summary study results indicated that when considered across all doses of MTK, no benefit to general cognition was observed when compared to change under placebo. However, when the data from the neuropsychological tests was analysed separately for each dose, adults with AD who received at least 80% of 30-mg twice-daily doses of MTK showed a statistically significant improvement in general cognition compared to placebo with the benefit being d= 0.5 in magnitude."

P2 data • Alzheimer's Disease • CNS Disorders

Safety, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P2 | N=52 | Completed | Sponsor: IntelGenx Corp. | Active, not recruiting ➔ Completed | Phase classification: P2a ➔ P2

Phase classification • Trial completion • Alzheimer's Disease • CNS Disorders

IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm in Phase 2 ‘MONTPARK’ Clinical Trial (GlobeNewswire) - "IntelGenx...announced that Montelukast VersaFilm has been administered to the first Parkinson’s Disease ('PD') patients in the Phase 2 (‘MONTPARK’) clinical 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."

Trial status • Parkinson's Disease

IntelGenx Receives Approval to Conduct ’MONTPARK’ Montelukast VersaFilm Phase 2 Clinical Trial in Patients with Parkinson’s Disease (GlobeNewswire) - "IntelGenx Corp...today announced that the Swedish Medical Products Agency ('MPA'), the Swedish Ethical Review Authority, and the Regional Biobank Centre have approved the planned clinical study to investigate the use of IntelGenx’s Montelukast VersaFilm^® for the treatment of Parkinson’s Disease ('PD')....The Phase 2 MONTPARK study...is a 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....The study is expected to begin recruiting in Q1 2024 with an expected study duration of approximately 24-to-30 months, depending on the recruitment rate."

New P2 trial • CNS Disorders • Parkinson's Disease

Safety, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P2a | N=54 | Active, not recruiting | Sponsor: IntelGenx Corp. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Oct 2023 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

IntelGenx Completes Enrollment for ‘BUENA’ Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease (GlobeNewswire) - "IntelGenx Corp...today announced that it has completed patient enrollment in the ongoing Montelukast VersaFilm® Phase 2a ('BUENA') clinical trial in patients with mild to moderate Alzheimer’s Disease ('AD'). The Company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a No Objection Letter ('NOL') from Health Canada. The NOL provided authorization to proceed with the study changes. IntelGenx, in consultation with its statistical consultant, Cogstate Ltd., determined that adjusting the p-value...'We are looking forward to completing the BUENA trial in the first quarter of 2024 and to reporting initial trial results the following quarter.'"

Clinical protocol • Enrollment closed • P2a data • Trial completion date • Alzheimer's Disease • CNS Disorders

IntelGenx Completes Enrollment for ‘BUENA’ Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease (GlobeNewswire) - "IntelGenx Corp...today announced that it has completed patient enrollment in the ongoing Montelukast VersaFilm Phase 2a ('BUENA') clinical trial in patients with mild to moderate Alzheimer’s Disease ('AD')....The Company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a No Objection Letter ('NOL') from Health Canada....We are looking forward to completing the BUENA trial in the first quarter of 2024 and to reporting initial trial results the following quarter.'"

Enrollment closed • P2a data • Trial completion date • Alzheimer's Disease • CNS Disorders

IntelGenx Provides Update on Research Collaboration Evaluating Montelukast VersaFilm for the Treatment of Parkinson’s Disease (GlobeNewswire) - "IntelGenx Corp...today announced the execution of a Research Grant Agreement with Karolinska University Hospital and that the manufacturing of both active and placebo films are underway in preparation for a planned multicentre, randomized, double-blind, placebo-controlled clinical study (the 'Study') to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease ('PD')....Prof. Svenningsson will sponsor the study through a 20 million Swedish Crowns grant (approx. $2 million USD) awarded by the Swedish Research Council, Sweden’s largest governmental research funding body. Upon completion of the Study, IntelGenx will have the option to acquire the developed intellectual property rights and study data for a predetermined low five-digit amount and use the findings to further develop its Montelukast VersaFilm® program for PD treatment."

Licensing / partnership • CNS Disorders • Parkinson's Disease

IntelGenx Announces Research Collaboration with Renowned Neurologist to Evaluate Montelukast VersaFilm for the Treatment of Parkinson’s Disease (GlobeNewswire) - "IntelGenx Corp...today announced a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study (the 'Study') to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease ('PD'). Dr. Svenningsson will serve as the Principal Investigator for the planned Study....IntelGenx will supply Dr. Svenningsson with both active and placebo films to be used in the 18-month treatment regimen for study participants. Upon completion of the Study, IntelGenx will retain the intellectual property rights and use the findings to further develop its Montelukast VersaFilm® program for Parkinson's disease treatment. The Study is currently expected to commence in the third quarter of 2023."

Licensing / partnership • New trial • CNS Disorders • Parkinson's Disease

IntelGenx Announces Enrollment Reaches Halfway Mark in ‘BUENA’ Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease (GlobeNewswire) - "IntelGenx Corp…announced that patient enrollment in the ongoing Montelukast VersaFilm^® Phase 2a (‘BUENA’) clinical trial in patients with mild to moderate Alzheimer’s Disease (‘AD’) has reached the halfway mark. This proof-of-concept study currently includes six clinical research sites with the potential of adding two more sites in the coming month, all of which are expected to enroll a total of approximately 70 patients….‘We continue to work diligently to improve the recruitment rate even further, and anticipate completing enrollment before the end of 2022."

Enrollment status • Alzheimer's Disease • CNS Disorders

Safety, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P2a | N=70 | Recruiting | Sponsor: IntelGenx Corp. | Unknown status ➔ Recruiting | Trial completion date: Jul 2021 ➔ Dec 2023 | Trial primary completion date: Nov 2020 ➔ Oct 2023

Enrollment open • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Patient Screening to Resume in IntelGenx’s ‘BUENA’ Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease (GlobeNewswire) - "IntelGenx Corp...today announced its intention to resume patient screening in the ongoing Montelukast VersaFilm® Phase 2a ('BUENA') clinical trial in patients with mild to moderate Alzheimer’s Disease ('AD') following Health Canada’s ('HC') issuance of a No Objection Letter ('NOL') in response to IntelGenx’s amended Clinical Trial Application....This NOL now paves the way for patient screening under the amended protocol to resume in October 2021."

Trial status • Alzheimer's Disease • CNS Disorders

First Patient Dosed in IntelGenx’s Resumed ‘BUENA’ Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease (GlobeNewswire) - “IntelGenx Corp…today announced that patient dosing has resumed in the ongoing Phase 2a (‘BUENA’) clinical trial in patients with mild to moderate Alzheimer’s Disease ('AD') under a previously amended protocol using higher doses of Montelukast VersaFilm®.”

Trial status • Alzheimer's Disease • CNS Disorders

Improved Bioavailability of Montelukast through a Novel Oral Mucoadhesive Film in Humans and Mice. (PubMed, Pharmaceutics) - "The oral film might lower the non-responder rate in patients with asthma and might be an interesting product for repurposing of MTK in other diseases. As we demonstrate Blood-Brain-Barrier (BBB) penetrance in a preclinical model, as well as in a clinical study, the oral film of MTK might find its use as a therapeutic for acute and chronic neurodegenerative diseases such as dementias and stroke."

Journal • Allergic Rhinitis • Alzheimer's Disease • Asthma • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Immunology • Respiratory Diseases

IntelGenx Reports First Quarter 2020 Financial Results (GlobeNewswire, IntelGenx Corp.) - "Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm® Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.; Announced that a cannabis-infused VersaFilm® product has been finalized with its co-development partner, and all manufacturing scale-up work has been successfully completed."

Canadian regulatory • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

[VIRTUAL] MONTELUKAST IN MICE AND MAN – PRECLINICAL AND CLINICAL (BUENA STUDY) DATA OF LEUKOTRIENE INHIBITION IN ALZHEIMER´S DISEASE (AAT-ADPD 2020) - P2a | "Conclusions The results from the preclinical study indicate that MTK improves cognitive function and influences neuroinflammation. MTK might be a novel effective therapeutic as part of the armamentarium against AD."

Late-breaking abstract

IntelGenx reports fourth quarter and full-year 2019 financial results (Market Screener) - "Received a No Objection Letter from Health Canada in response to IntelGenx’s amended Clinical Trial Application for the ongoing Montelukast VersaFilm® Phase 2a ('BUENA') clinical trial in patients with mild to moderate Alzheimer’s Disease; Signed a binding term sheet with Orivas for the commercialization of RIZAPORT® pursuant to which Orivas will obtain exclusive rights to market and sell RIZAPORT® in Lithuania, Latvia, Estonia and Poland, with the right of first refusal for a predefined term to include the Republic of Belarus and/or the Republic of Ukraine, as well as any of the Scandinavian countries (Finland, Denmark, Sweden and Norway)."

Canadian regulatory • Commercial

IntelGenx Receives Health Canada Authorization to Proceed with New Amendment for Montelukast VersaFilm® Phase 2a Trial (GlobeNewswire, IntelGenx Corp.) - "IntelGenx Corp...today announced that Health Canada has issued a No Objection Letter in response to IntelGenx’s amended Clinical Trial Application ('CTA') for the ongoing Montelukast VersaFilm® Phase 2a ('BUENA') clinical trial in patients with mild to moderate Alzheimer’s Disease ('AD')....'We are looking forward to continuing enrollment at our Canadian sites under this amended protocol, which is based on preclinical data demonstrating Montelukast VersaFilm’s increased efficacy at higher doses.'"

Canadian regulatory • Enrollment status • Preclinical • Trial status

Safety, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease (clinicaltrials.gov) - P2a; N=70; Recruiting; Sponsor: IntelGenx Corp.; Trial completion date: Oct 2020 ➔ Jul 2021; Trial primary completion date: Jul 2020 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date

THE BUENA STUDY: A PHASE 2A CLINICAL TRIAL TO TEST SAFETY AND EFFICACY OF MONTELUKAST VERSAFILMTM IN ALZHEIMER’S PATIENTS. (CTAD 2019) - P2a; "This composite score is based on an equally weighted average of standardized change from baseline scores on the ISLT, ISLT-Delay, One Back Test, One Card Learning Test, Verbal Fluency Test, Category Fluency Test, Identi cation Test and Detection Test. Given the inherent attributes of Montelukast VersaFilmTM, this might be a novel effective therapeutic and treatment modality as part of the armamentarium against AD."

Clinical • P2a data

IntelGenx reports third quarter 2019 financial results (GlobeNewswire) - "Received a positive Data Safety Monitoring Board recommendation that the Company’s Montelukast VersaFilm® Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease continue."

Trial status

The BUENA Study: A Phase 2A Clinical Trial To Test Safety and Efficacy of Montelukast Versafilm™ in Alzheimer’s Patients (CTAD 2019) - No abstract available.

Clinical • P2a data