CysLT1

Phase 2 MONTPARK trial expected to begin recruiting patients in Q1 2024SAINT LAURENT, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") 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”). PD is the second most common neurodegenerative disease after Alzheimer's disease, with an estimated 9 million patients globally and 1 million patients in the United States.1,2 In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year.2 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.3 Montelukast is a CysLT1 antagonist which decreases neuroinflammation by inhibiting CysLT1. Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and Alzheimer’s Disease. The Phase 2 MONTPARK study (CT number 2023-504278-39-00) 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. Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents. 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. The study will be conducted at the Karolinska University Hospital and at 3 other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who will serve as the Study’s Principal Investigator. 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. “We are delighted that this trial has been approved by the MPA and look forward to beginning patient recruitment as soon as possible,” said Dwight Gorham, IntelGenx’s CEO. “We are excited to be collaborating with Prof. Svenningsson, a PD pathogenesis expert who previously demonstrated the safety and tolerability of 40 mg Montelukast in PD patients. MONTPARK will be evaluating daily Montelukast doses of 60 mg per day, making Montelukast VersaFilm® a more attractive dosing method due to its increased bioavailability (approx. 50% improvement over tablets) and minimizing the need on a daily basis for the requirement of numerous 10 mg Montelukast tablets.” Prof. Svenningsson stated, “Our study teams are quite eager and ready to commence the study with the novel IntelGenx Montelukast VersaFilm® due to the beneficial features of the film in terms of ease of use, better compliance and bioavailability”. References 1 World Health Organization: https://www.who.int/news/item/14-06-2022-launch-of-who-s-parkinson-disease-technical-brief#:~:text=Globally%2C%20the%20prevalence%20of%20Parkinson,million%20individuals%20living%20with%20PD 2 Parkinson’s Foundation: https://www.parkinson.org/understanding-parkinsons/statistics 3 Wallin, J; Svenningsson, P. Potential Effects of Leukotriene Receptor Antagonist Montelukast in Treatment of Neuroinflammation in Parkinson’s Disease. Int. J. Mol. Sci. 2021, 22, 5606 About IntelGenx IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm® and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com. Forward-Looking Information and Statements This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedarplus.ca. IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen KilmerInvestor Relations(647) 872-4849stephen@kilmerlucas.com Or Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514) 331-7440 ext 203andre@intelgenx.com

SAINT LAURENT, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") 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”). PD is the second most common neurodegenerative disease after Alzheimer's disease, with an estimated 9 million patients globally and 1 million patients in the United States.1,2 In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year.2 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.3 Montelukast is a CysLT1 antagonist which decreases neuroinflammation by inhibiting CysLT1. Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and Alzheimer’s Disease. The Phase 2 MONTPARK study (CT number 2023-504278-39-00) 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. Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents. 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. The study will be conducted at the Karolinska University Hospital and at 3 other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who will serve as the Study’s Principal Investigator. 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. “We are delighted that this trial has been approved by the MPA and look forward to beginning patient recruitment as soon as possible,” said Dwight Gorham, IntelGenx’s CEO. “We are excited to be collaborating with Prof. Svenningsson, a PD pathogenesis expert who previously demonstrated the safety and tolerability of 40 mg Montelukast in PD patients. MONTPARK will be evaluating daily Montelukast doses of 60 mg per day, making Montelukast VersaFilm® a more attractive dosing method due to its increased bioavailability (approx. 50% improvement over tablets) and minimizing the need on a daily basis for the requirement of numerous 10 mg Montelukast tablets.” Prof. Svenningsson stated, “Our study teams are quite eager and ready to commence the study with the novel IntelGenx Montelukast VersaFilm® due to the beneficial features of the film in terms of ease of use, better compliance and bioavailability”. References 1 World Health Organization: 2 Parkinson’s Foundation: 3 Wallin, J; Svenningsson, P. Potential Effects of Leukotriene Receptor Antagonist Montelukast in Treatment of Neuroinflammation in Parkinson’s Disease. Int. J. Mol. Sci. 2021, 22, 5606 About IntelGenx IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films. IntelGenx’s superior film technologies, including VersaFilm®, DisinteQ™, VetaFilm® and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers significant benefits to patients and physicians for many therapeutic conditions. IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit . Forward-Looking Information and Statements This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at , and also filed with Canadian securities regulatory authorities at . IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen Kilmer Investor Relations (647) 872-4849 stephen@kilmerlucas.com Or Andre Godin, CPA, CA President and CFO IntelGenx Corp. (514) 331-7440 ext 203 andre@intelgenx.com

本文数据来自于CPM新药研发监测数据库（cpm.pharmadl.com）。精神障碍用药2022年NMPA批准的进口消化系统用药，共计24个（按照注册证号分类），获批品种较多的企业有H Lundbeck A/S（8个）、Aurobindo Pharma Ltd（4个）；涉及靶点排名前三的是5-HTT（11个）、ADRA2A（4个）、DRD2（4个）。在政策相关度方面，2022年获批的进口消化系统用药中，2022国家医保目录品种共有19个，带量采购招标品种有1个。呼吸系统用药2022年NMPA批准的进口呼吸系统用药，共计22个（按照注册证号分类），获批品种最多的企业是Organon Pharma (UK) Ltd（6个）。涉及较多的靶点是ADRB2（6个）、CYSLTR1（6个）。在政策相关度方面，2022年获批的进口血液和造血系统用药中，2022国家医保目录品种共有21个，没有带量采购招标品种。骨骼与肌肉用药2022年NMPA批准的进口内分泌及代谢调节用药，共计23个（按照注册证号分类），获批品种最多的企业是Organon Pharma (UK) Ltd（8个）。涉及靶点排名前三的是COX-2（12个）、IL6（4个）。在政策相关度方面，2022年获批的进口内分泌及代谢调节用药中，2022国家医保目录品种共有22个，没有带量采购招标品种。泌尿系统用药2022年NMPA批准的进口内分泌及代谢调节用药，共计10个（按照注册证号分类），获批品种最多的三家企业分别是Astellas Pharma Europe BV（8个）、Genzyme Europe BV（3个）、Meda Pharma Gmbh & Co Kg（2个）。涉及最多的靶点是ADRB3（4个）。在政策相关度方面，2022年获批的进口内分泌及代谢调节用药中，2022国家医保目录品种共有7个，没有带量采购招标品种。年度发布2023年《全球药研新动态》《中国医院市场用药格局》（2023版）2023年《数图药讯》权威发布2021年度中国医药工业百强榜单解读中国仿制药发展报告（2022版）医药行业专项报告中国医药中间体和原料药行业调研报告中国非甾体抗炎类原料药市场调研报告中国祛痰类原料药市场调研报告中国钙拮抗剂类原料药市场调研报告中国血管紧张素Ⅱ受体拮抗剂类原料药市场调研报告中国口服血糖调节类原料药市场调研报告中国中枢兴奋类原料药市场调研报告中国抗痛风类原料药市场调研报告中国脑血管病类原料药市场调研报告END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001