SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the 'Company' or 'IntelGenx') today 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.

2024年4月8日，魁北克省圣洛朗（环球通讯社）--IntelGenx Corp.（TSX:IGX）（OTCQB:IGXT）（“公司”或“IntelGenx”）今天宣布，孟鲁司特VersaFilm®已用于第二阶段（“MONTPARK”）临床试验中的第一名帕金森病（“PD”）患者。MONTPARK（EudraCT编号2023-504278-39-00）是一项2期随机、双盲、安慰剂对照、平行组、多中心试验，将研究口服大剂量孟鲁司特对早期至中度PD进展的疗效。

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.

该研究将招募多达90名患者，他们将接受30毫克孟鲁司特VersaFilm®或安慰剂，每天两次，持续18个月，然后进行3个月的清除期。符合条件的候选人在入学时必须接受左旋多巴治疗，也可能接受其他多巴胺能症状药物治疗。MONTPARK正在卡罗林斯卡大学医院和其他三所瑞典大学附属机构进行研究，IntelGenx之前宣布与Per Svenningsson博士进行研究合作，Per Svenningsson博士是该研究的首席首席研究员。

“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.

IntelGenx首席执行官德怀特·戈勒姆（Dwight Gorham）表示：“在2期MONTPARK试验中，首批PD患者的剂量是孟鲁司特VersaFilm®临床开发的一个重要里程碑，目前正在进行的‘BUENA’2a期研究中，该药物也被用于治疗轻度至中度阿尔茨海默病（AD）。”。

“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.” About Parkinson’s Disease PD is the second most common neurode.

“由于PD和AD等神经退行性疾病的治疗选择仍然有限，通过MONTPARK和BUENA等研究，我们正在采取重大步骤，为患者提供一种新型的疾病缓解治疗方法，该治疗方法还提供了一种特别适合他们需求的给药方法。”关于帕金森氏病PD是第二常见的神经病。