Almee™, developed by Alex Therapeutics in partnership with Vicore Pharma, is a mobile app that offers personalized treatment for anxiety based on cognitive behavioral therapy (CBT)

阿尔梅™, Alex Therapeutics与Vicore Pharma合作开发的移动应用程序，基于认知行为疗法（CBT）为焦虑症提供个性化治疗

The pivotal trial demonstrated significantly reduced levels of anxiety and improved quality of life for people living with pulmonary fibrosis, a chronic and fatal disease

这项关键性试验表明，患有肺纤维化（一种慢性致命疾病）的人的焦虑水平显着降低，生活质量得到改善

STOCKHOLM, Jan. 4, 2024 /PRNewswire/ -- Alex Therapeutics and Vicore Pharma today announced positive results of the COMPANION study, investigating the efficacy of Almee, a 9-week digital cognitive behavioral therapy (CBT) intervention accessed through a smartphone or tablet.

斯德哥尔摩，2024年1月4日/PRNewswire/--Alex Therapeutics和Vicore Pharma今天宣布了这项配套研究的积极结果，调查了Almee的疗效，Almee是一种通过智能手机或平板电脑进行的为期9周的数字认知行为治疗（CBT）干预措施。

The study met its primary endpoint, change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement compared to control, where a change in GAD-7 score of more than 1.8 is considered clinically meaningful.1 The GAD-7 scale is widely used in clinical practice as an assessment tool for anxiety; scoring ranges from 0 to 21 with four levels spanning minimal anxiety (0 to 4) to severe (15 to 21).

该研究达到了其主要终点，即GAD-7焦虑评分从基线变化，与对照组相比，统计学上显着提高了2.7分，其中GAD-7评分变化超过1.8被认为具有临床意义。GAD-7量表在临床实践中被广泛用作焦虑评估工具；评分范围从0到21，有四个级别，从最小焦虑（0到4）到严重（15到21）。

The observed 2.7-point improvement reflects promising efficacy in reducing anxiety levels and offering tangible relief to individuals coping with pulmonary fibrosis (PF). Quality of life, measured by the K-BILD,2 was a key secondary endpoint and improved by 4.4 points compared to control, and the K-BILD psychological domain improved by 6.5 points..

观察到的2.7分改善反映了在降低焦虑水平和为应对肺纤维化（PF）的个体提供有形缓解方面的有希望的功效。通过K-BILD测量的生活质量2是一个关键的次要终点，与对照组相比提高了4.4分，K-BILD心理领域提高了6.5分。。

The COMPANION study enrolled 108 participants from across the United States in a randomized, controlled, parallel-group clinical investigation evaluating the impact of Almee on the psychological symptom burden in adults diagnosed with PF. Living with a deadly disease for which there is currently no curative treatment available has a negative impact on mental health and quality of life3; the aim of Almee is to provide personalized and accessible psychological support for these patients..

伴随研究招募了来自美国各地的108名参与者参加了一项随机，对照，平行组临床研究，评估了Almee对诊断为PF的成年人心理症状负担的影响。患有致命疾病，目前尚无治疗方法，对心理健康和生活质量产生负面影响3；Almee的目的是为这些患者提供个性化和可获得的心理支持。。

'It's very rewarding to see that our tailored, evidence-based CBT intervention in Almee had a clinically meaningful impact for PF patients suffering from anxiety. The results of the COMPANION study demonstrate what can be achieved through a great partnership like the one we've had with Vicore Pharma.

“看到我们在阿尔梅量身定制的循证CBT干预对患有焦虑症的PF患者产生了临床意义上的影响，这是非常有益的。伴随研究的结果表明，通过像我们与Vicore Pharma这样的良好合作关系可以实现什么。

It's really groundbreaking, with so few digital therapies having published such positive randomized controlled trial results to date. We've shown how partnering to design and develop engaging, user-friendly, patient-facing apps is the best way to work together to change behavior and improve patient outcomes.' said John Drakenberg, CEO of Alex Therapeutics..

这真的是开创性的，迄今为止，很少有数字疗法发表了如此积极的随机对照试验结果。我们已经展示了合作设计和开发吸引人、用户友好、面向患者的应用程序是如何共同改变行为和改善患者预后的最佳方式。”Alex Therapeutics首席执行官约翰·德拉肯伯格（JohnDrakenberg）表示。。

'It is very encouraging to see a digital CBT demonstrating a clear clinical benefit for individuals suffering from the mental health burden that accompanies pulmonary fibrosis,' said COMPANION study Principal Investigator Dr. Maureen Horton, Professor of Pulmonary and Critical Care Medicine Johns Hopkins University School of Medicine, retired.

COMPANION研究首席研究员、约翰·霍普金斯大学医学院（Johns Hopkins University School of Medicine）肺与重症医学教授莫林·霍顿（Maureen Horton）博士（Dr.Maureen Horton）退休后说：“看到数字CBT为患有肺纤维化的心理健康负担的个体显示出明显的临床益处，这非常令人鼓舞。”。

'Providing behavior-modifying tools that enhance quality of life represents a new addition to a comprehensive treatment approach for patients suffering from this devastating disease.'.

“为患有这种毁灭性疾病的患者提供改善行为的工具，以提高生活质量，这是对综合治疗方法的新补充。”。

'We're so pleased to see these positive results in the COMPANION pivotal study,' said Ahmed Mousa, Chief Executive Officer of Vicore, 'and believe that Almee can play a key role in combination with molecular therapies to address individuals suffering from pulmonary fibrosis in a holistic way.'           .

Vicore首席执行官艾哈迈德·穆萨（AhmedMousa）说：“我们很高兴在配套的关键研究中看到这些积极的结果，并相信阿尔梅可以与分子疗法相结合，在整体解决肺纤维化患者方面发挥关键作用。”。

Kounali D, Button KS, Lewis G, Gilbody S, Kessler D, Araya R, Duffy L, Lanham P, Peters TJ, Wiles N, Lewis G. How much change is enough? Evidence from a longitudinal study on depression in UK primary care. Psychol Med. 2022 Jul;52(10):1875-1882. doi: 10.1017/S0033291720003700. Epub 2020 Nov 3. PMID: 33138872; PMCID: PMC9340848.          .

库纳利D，巴顿KS，刘易斯G，吉尔博迪S，凯斯勒D，阿拉亚R，达菲L，兰厄姆P，彼得斯TJ，怀尔斯N，刘易斯G。多少变化就足够了？来自英国初级保健抑郁症纵向研究的证据。心理学医学，2022年7月；52（10）：1875-1882。doi:10.1017/S0033291720003700。Epub 2020年11月3日。PMID:33138872；PMCID:PMC9340848。

King's Brief Interstitial Lung Disease (KBILD) is a 15-item validated health-related quality of life (HRQOL) questionnaire. Nolan CM, Birring SS, Maddocks M, Maher TM, Patel S, Barker RE, Jones SE, Walsh JA, Wynne SC, George PM, Man WD. King's Brief Interstitial Lung Disease questionnaire: responsiveness and minimum clinically important difference.

金氏短暂间质性肺病（KBILD）是一项经过15项验证的健康相关生活质量（HRQOL）问卷。诺兰CM，伯林SS，马多克斯M，马赫TM，帕特尔S，巴克RE，琼斯SE，沃尔什JA，温恩SC，乔治PM，曼WD。金氏简明间质性肺病问卷：反应性和最小临床重要差异。

Eur Respir J. 2019 Sep 5;54(3):1900281. doi: 10.1183/13993003.00281-2019. PMID: 31221807.           .

Eur Respir J.2019年9月5日；54（3）：1900281。doi:10.183/139930003.00281-2019。PMID:33121807。

Yohannes, AM (2020) Depression and anxiety in patients with interstitial lung disease, Expert Review of Respiratory Medicine, 14:9, 859-862, DOI: 10.1080/17476348.2020.1776118

Yohannes，AM（2020）《间质性肺病患者的抑郁和焦虑》，呼吸医学专家评论，14:9859-862，DOI:10.1080/17476348.2020.1776118

For further information, please contact:

欲了解更多信息，请联系：

Dan Paech, Strategic Partnership Manager, t: +46 (0)762585271, e: [email protected]John Drakenberg, CEO, t: +46 (0)708830035, e:[email protected]

战略伙伴关系经理丹·佩奇（DanPaech），电话：+46（0）762585271，电子：[受电子邮件保护]约翰·德拉肯伯格（JohnDrakenberg），首席执行官，电话：+46（0）708830035，电子：[受电子邮件保护]

About Alex Therapeutics

关于Alex Therapeutics

Alex Therapeutics, a digital health company, partners with pharmaceutical companies to help patients with disease and treatment-specific challenges through clinically validated apps. With its proven, scalable technology platform, as well as expertise in patient-centric design and evidence-based behavior change, Alex Therapeutics treats patients and supports healthcare professionals globally.

数字健康公司Alex Therapeutics与制药公司合作，通过临床验证的应用程序帮助患有疾病和治疗特定挑战的患者。Alex Therapeutics凭借其经过验证的可扩展技术平台，以及以患者为中心的设计和循证行为改变方面的专业知识，为全球的患者提供治疗和支持。

Alex Therapeutics, alongside its partners, has extensive experience in multi-jurisdiction Software-as-a-Medical-Device (SaMD) regulatory processes, including CE and FDA approval, as well as clinical evidence generation for SaMDs. For more information, visit www.alextherapeutics.com..

Alex Therapeutics及其合作伙伴在多司法管辖区软件即医疗设备（SaMD）监管流程方面拥有丰富经验，包括CE和FDA的批准，以及SaMD的临床证据生成。有关更多信息，请访问www.alextherapeutics.com。。

About Vicore Pharma Holding AB (publ)

关于Vicore Pharma Holding AB（publ）

Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF.

Vicore是一家创新的临床阶段制药公司，它释放了一类具有疾病缓解潜力的新型药物的潜力。该公司正在建立包括特发性肺纤维化（IPF）在内的呼吸系统疾病投资组合。C21是目前处于IPF 2a期开发的一流口服小分子血管紧张素II 2型受体激动剂（ATRAG）。

Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications.

阿尔梅™ （临床开发中的研究性医疗器械）是一种基于认知行为疗法的数字治疗方法，旨在解决肺纤维化患者的心理影响。利用其在ATRAG化学和生物学方面的独特专业知识，Vicore正在通过其他潜在适应症的几种新疗法进一步推动其管道。

The company's shares (VICO) are listed on Nasdaq Stockholm's main market. For more information, see www.vicorepharma.com..

该公司股票（VICO）在纳斯达克斯德哥尔摩的主要市场上市。有关更多信息，请访问www.vicorepharma.com。。

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/21311/3903769/2521976.pdf

https://mb.cision.com/Main/21311/3903769/2521976.pdf

Press release (PDF)

新闻稿（PDF）

https://news.cision.com/alex-therapeutics/i/4th-jan-press-release-banner,c3255235

https://news.cision.com/alex-therapeutics/i/4th-jan-press-release-banner，c3255235

4th Jan press release banner

1月4日新闻发布横幅