Almee™ – anxiety in Pulmonary Fibrosis

Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis.

The COMPANION pivotal study (2022-2023) evaluating the efficacy of Almee met its primary endpoint: change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement of anxiety symptoms in the group treated with Almee compared to control, where a change in GAD-7 score of more than 1.8 points is considered clinically meaningful[1].

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.

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[1] 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.

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). The observed 2.7-point improvement reflects promising efficacy in reducing anxiety levels and offering tangible relief to individuals coping with pulmonary fibrosis (PF).

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