Swedish pharma company Vicore has won breakthrough status from the FDA for Almee, a cognitive behavioural therapy (CBT) app used to support people with pulmonary fibrosis (PF).

瑞典制药公司Vicore为Almee赢得了FDA的突破性地位，Almee是一种用于支持肺纤维化患者的认知行为疗法（CBT）应用程序。

Almee takes the form of a nine-week CBT course that has been shown in clinical testing to reduce the psychological burden of living with PF, a progressive and life-threatening disease with an average life expectancy for patients of just three to five years. It is being developed in association with digital health specialist Alex Therapeutics..

Almee采用为期九周的CBT课程的形式，临床测试表明，该课程可以减轻患有PF的心理负担，PF是一种进行性和危及生命的疾病，患者的平均预期寿命仅为三到五年。它正在与数字健康专家Alex Therapeutics联合开发。。

The FDA’s breakthrough device designation can speed up the development of new medical devices and digital health technologies, becoming eligible for a prioritised review, which can sometimes result in shorter development and review times.

FDA突破性的设备指定可以加快新医疗设备和数字健康技术的开发，有资格进行优先审查，这有时会缩短开发和审查时间。

In the pivotal COMPANION trial reported earlier this year, Almee achieved a statistically significant 2.7-point reduction in anxiety score – measured using the GAD-7 scale – over the course of four weeks’ follow-up.

在今年早些时候报道的关键性COMPANION试验中，Almee在四周的随访过程中，焦虑评分（使用GAD-7量表测量）降低了2.7分，具有统计学意义。

A 2.7-point reduction corresponds to “tangible relief” for patients with PF, according to the study investigators, who also found a 4.4-point improvement in KBILD total score, a scale which looks at quality of life.

根据研究调查人员的说法，减少2.7分相当于PF患者的“明显缓解”，他们还发现KBILD总分提高了4.4分，这是一种衡量生活质量的量表。

Anxiety is common in people with PF, reflecting the fact that current treatments can only slow down the progression of the disease, which affects around 250,000 people in the US alone. Symptoms of the disease include cough, fatigue, and shortness of breath which get more debilitating and distressing over time..

焦虑在PF患者中很常见，这反映了一个事实，即目前的治疗只能减缓疾病的进展，仅在美国就有约25万人受到这种疾病的影响。这种疾病的症状包括咳嗽、疲劳和呼吸急促，随着时间的推移，这些症状会变得更加虚弱和痛苦。。

It is estimated that around two-thirds (60%) of PF patients experience anxiety, which Almee tries to alleviate by helping patients understand and manage their condition better and break the cycle of feelings that lead to anxiety and fear.

据估计，大约三分之二（60%）的PF患者经历焦虑，阿尔梅试图通过帮助患者更好地理解和管理自己的病情，打破导致焦虑和恐惧的情绪循环来缓解焦虑。

Vicore said in a statement that the breakthrough status “reflects the effectiveness of [Almee] compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy.”

维科尔在一份声明中说，突破性进展“反映了[阿尔梅]与通常治疗肺纤维化相关焦虑症相比的有效性，并证明了这种数字疗法的影响力。”

Vicore – a specialist in respiratory disease therapies – joined forces with Alex in 2022 to develop the DTx, securing all rights to the therapy in exchange for an upfront payment of around $1 million, plus potential milestones and royalties.

Vicore是呼吸系统疾病治疗专家，于2022年与Alex联手开发DTx，以获得该疗法的所有权利，换取约100万美元的预付款，以及潜在的里程碑和版税。

The Swedish company says it plans to present full results from the COMPANION study at a conference later this year and is looking for partnerships with the developers of “approved and late-stage” molecular therapies for PF.

这家瑞典公司表示，它计划在今年晚些时候的一次会议上展示配套研究的全部结果，并正在寻找与PF“批准和晚期”分子疗法开发人员的合作伙伴关系。

Late-stage development candidates for PF – all vying to be first-in-class treatments – include Bristol-Myers Squibb’s LPA1 antagonist BMS-986278, Boehringer Ingelheim’s PDE4B inhibitor BI 1015550, and Pliant Therapeutics’ αvß6 and αvß1 integrin inhibitor bexotegrast.

PF的晚期发展候选者-都在争创一流的治疗方法-包括百时美施贵宝的LPA1拮抗剂BMS-986278，勃林格殷格翰的PDE4B抑制剂BI 1015550，以及柔韧治疗药物的αvß6和αvß1整联蛋白抑制剂贝索替加司特。