Alex Therapeutics and Vicore Pharma 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. 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). 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. 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.