GOTHENBURG, SWEDEN / ACCESSWIRE / May 6, 2024 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, May 6, 2024 - IRLAB Therapeutics AB (Nasdaq Stockholm:IRLAB A), a company discovering and developing novel treatments for Parkinson's disease, today announced that the Swedish Medical Products Agency has approved the initiation of a Phase I clinical study of the drug candidate IRL757.

瑞典哥德堡/ACCESSWIRE/2024年5月6日/IRLAB Therapeutics（STO:IRLAB-A）（FRA:6IRA）瑞典哥德堡，2024年5月6日-IRLAB Therapeutics AB（Nasdaq Stockholm:IRLAB A），一家发现和开发帕金森病新疗法的公司，今天宣布瑞典医疗产品管理局已批准启动候选药物IRL757的I期临床研究。

IRL757 is being developed as a treatment to counteract apathy - a condition that impairs the quality of life for millions of people with Parkinson's disease, Alzheimer's disease and other CNS diseases. The Phase I study is fully financed by the world's largest non-profit funder of Parkinson's research, The Michael J.

IRL757正在被开发作为一种治疗方法来抵消冷漠-这种情况会损害数百万帕金森氏病，阿尔茨海默病和其他中枢神经系统疾病患者的生活质量。第一阶段的研究由世界上最大的帕金森氏症研究非营利资助者迈克尔·杰克逊（MichaelJ。

Fox Foundation for Parkinson's Research..

福克斯帕金森病研究基金会。。

'Following the positive announcement from the Swedish Medical Products Agency, we now look forward to initiating the first clinical study of our drug candidate IRL757 shortly. The extensive research support granted by The Michael J. Fox Foundation for Parkinson's Research shows that world-leading external assessors share our confidence in the potential of IRL757 to counteract apathy, which today has no treatment and affects millions of individuals with neurodegenerative diseases and their relatives', comments Joakim Tedroff, MD, PhD, Chief Medical Officer, IRLAB..

“在瑞典医疗产品管理局（Swedish Medical Products Agency）发布积极声明后，我们现在期待着不久后启动我们候选药物IRL757的首次临床研究。迈克尔·福克斯基金会（MichaelJ.Fox Foundation）为帕金森氏症研究提供的广泛研究支持表明，世界领先的外部评估人员对IRL757抵抗冷漠的潜力充满信心，这种冷漠目前尚未得到治疗，影响了数百万神经退行性疾病患者及其亲属，IRLAB首席医学官JoakimTedroff博士评论道。。

Individuals suffering from apathy are characterized by indifference and resignation, rarely reacting to what is happening in the environment. The condition often causes significant disability and affects a large proportion of people living with Parkinson's disease, Alzheimer's disease and other diseases related to the central nervous system.

患有冷漠的人的特点是冷漠和顺从，很少对环境中发生的事情做出反应。这种情况通常会导致严重的残疾，并影响大部分患有帕金森病、阿尔茨海默病和其他与中枢神经系统有关的疾病的人。

There are currently no drugs on the market to treat apathy..

目前市场上没有治疗冷漠的药物。。

IRLAB's drug candidate IRL757 has shown positive effects in several preclinical models of cognitive function, including improved motivation. The effect is believed to be associated with the drug candidate's unique ability to counteract disruptions in the nerve signaling that occurs between the cerebral cortex and deeper brain parts and which is considered to be the cause of the onset of apathy in several neurological diseases..

IRLAB的候选药物IRL757在认知功能的几种临床前模型中显示出积极作用，包括改善动机。这种效应被认为与候选药物抵抗大脑皮层和大脑深层之间发生的神经信号中断的独特能力有关，这被认为是几种神经系统疾病冷漠发作的原因。。

The Phase I study consists of two parts and aims to document the safety, tolerability and pharmacokinetic properties of IRL757 in healthy subjects. In the first part of the study, single ascending doses of the drug candidate are administered (SAD) whereas the second part covers multiple ascending doses (MAD).

I期研究由两部分组成，旨在记录IRL757在健康受试者中的安全性，耐受性和药代动力学特性。在研究的第一部分中，给予单次递增剂量的候选药物（SAD），而第二部分涵盖多次递增剂量（MAD）。

In addition, the possible influence of concomitant food intake will be documented. The study is expected to be fully completed by the end of 2024 and top line results are expected to be presented in the first quarter of 2025..

此外，将记录伴随食物摄入的可能影响。该研究预计将于2024年底全面完成，最重要的结果预计将于2025年第一季度公布。。

The Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded a grant of approximately SEK 20 million to conduct this first Phase I clinical trial of IRL757. MJFF is the world's largest non-profit funder of Parkinson's disease research and the organization's support of IRL757 provides a strong external validation of the project's potential..

迈克尔·福克斯帕金森病研究基金会（MJFF）已拨款约2000万瑞典克朗进行IRL757的第一阶段临床试验。MJFF是世界上最大的帕金森病研究非营利资助者，该组织对IRL757的支持为该项目的潜力提供了强有力的外部验证。。

About IRL757

关于IRL757

The drug candidate IRL757 is being developed as a treatment for apathy in Parkinson's disease and other neurological conditions. Apathy, a widespread and debilitating issue, affects over 20 million people in the U.S. and Europe alone without a currently available treatment. The prevalence is high, occurring in 1.1-4 million people (20-70 percent) being treated with Parkinson's in the eight major markets (China, EU5, Japan, and the US), and in 4.9-6.7 million people (43-59 percent) being treated for Alzheimer's disease in the ten major markets (Canada, China, EU5, Japan, South Korea, and the US)..

候选药物IRL757正在开发中，用于治疗帕金森病和其他神经系统疾病的冷漠。冷漠是一个广泛而令人衰弱的问题，仅在美国和欧洲就有2000多万人受到影响，目前没有可用的治疗方法。患病率很高，在八个主要市场（中国、欧盟5国、日本和美国）有110-400万人（20-70%）接受帕金森病治疗，在十个主要市场（加拿大、中国、欧盟5国、日本、韩国和美国）有490-670万人（43-59%）接受阿尔茨海默病治疗。。

RL757 has the potential to become the first treatment for apathy. IRL757 has shown promising results in various preclinical models, which assess different aspects of cognitive function and motivation. The observed efficacy of IRL757 is thought to be linked to its unique ability to reverse disruption in cortical to sub-cortical nerve signaling, a key factor believed to contribute to apathy in neurological disorders.

RL757有可能成为冷漠的第一种治疗方法。IRL757在各种临床前模型中显示出有希望的结果，这些模型评估了认知功能和动机的不同方面。IRL757观察到的功效被认为与其逆转皮质至皮质下神经信号传导中断的独特能力有关，这是导致神经系统疾病冷漠的关键因素。

IRL757 is considered Phase I ready as all preclinical studies and development work necessary to start Phase I is completed..

IRL757被认为是第一阶段准备就绪，因为开始第一阶段所需的所有临床前研究和开发工作都已完成。。

About IRLAB

关于IRLAB

IRLAB is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson's disease. The company has its origin in Nobel Laureate Prof. Arvid Carlsson's research group and the discovery of a connection between the brain's neurotransmitters and CNS disorders. Mesdopetam (IRL790), in development for the treatment of levodopa-induced dyskinesias, has completed Phase IIb and is in preparation toward Phase III.

IRLAB正在发现并开发针对帕金森病各个阶段的转化疗法组合。该公司起源于诺贝尔奖获得者阿维德·卡尔松教授的研究小组，并发现大脑神经递质与中枢神经系统疾病之间存在联系。正在开发用于治疗左旋多巴引起的运动障碍的甲磺酸异丙胺（IRL790）已完成IIb期，并正在准备进入III期。

Pirepemat (IRL752), is currently in Phase IIb, being evaluated for its effect on balance and fall frequency in Parkinson's disease. In addition, the company is also progressing the three preclinical programs IRL757 (financially supported by the Michael J. Fox Foundation), IRL942, and IRL1117 towards Phase I studies.

Pirepemat（IRL752）目前处于IIb期，正在评估其对帕金森病平衡和跌倒频率的影响。此外，该公司还正在将三个临床前项目IRL757（由迈克尔·J·福克斯基金会资助），IRL942和IRL1117推进I期研究。

IRLAB's pipeline has been generated by the company's proprietary systems biology-based Integrative Screening Process (ISP) research platform. Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). For more information, please visit www.irlab.se..

IRLAB的管道是由该公司专有的基于系统生物学的综合筛选过程（ISP）研究平台生成的。IRLAB总部位于瑞典，在纳斯达克斯德哥尔摩（Nasdaq Stockholm，IRLAB A）上市。有关更多信息，请访问www.irlab.se。。

Attachments

附件

IRLAB has received approval from the Swedish Medical Products Agency to conduct a Phase I study of the drug candidate IRL757

IRLAB已获得瑞典医疗产品管理局的批准，对候选药物IRL757进行I期研究