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.

Anxiety is a common symptom in Idiopathic Pulmonary Fibrosis, with prevalence estimates as high as 60%. A US claims analysis reveals that 31% of patients with pulmonary fibrosis and 39% of patients with Idiopathic Pulmonary Fibrosis are prescribed medications for anxiety or depression.

Almee™ is intended to be used on top of standard of care for pulmonary fibrosis and is not intended to treat the physical aspects of pulmonary fibrosis. The therapy will be delivered in a sequence of interactive modules of neurobehavioral interventions, patient education, and skill- building, and consists of sound exercises, video exercises, and interactive exercises as part of the CBT toolbox. Cognitive behavioral therapy (CBT) is a well-established method to support patients who carry a high psychological burden caused by severe disease. A digital CBT is delivered via a software application on a patient’s mobile device, can be personalized and is accessible round-the-clock to meet the patient’s individual needs and schedule.

Read more about Almee here:

The COMPANION pivotal study 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.

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 pulmonary fibrosis.

 Vicore plans to present full results from the COMPANION study at a conference in 2024. The company will seek to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis, spearheading the continued development of innovation in improved therapy with software-molecular combination therapies.

[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.