The COMPANION pivotal study evaluating the efficacy and safety 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. A change in GAD-7 score of more than 1.8 points is considered clinically meaningful1.
.png)
Quality of life, measured by the ILD specific K-BILD2, was a key secondary endpoint and improved by 4.4 points compared to control. The psychological domain of K-BILD 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. 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.
“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. “Providing behavior-modifying tools that enhance quality of life represents a new addition to a comprehensive treatment approach for patients living with this devastating disease.”
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.
3 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
