Alex Therapeutics and Vicore Pharma announced today the positive results of the COMPANION study, which investigated the effectiveness of Almee, a 9-week digital cognitive behavioral therapy (CBT) accessible via smartphone or tablet.
The study met its primary endpoint, showing a statistically significant improvement of 2.7 points in GAD-7 anxiety scores compared to the control. The GAD-7 scale is commonly used to assess anxiety levels, and the observed improvement reflects promising effectiveness in reducing anxiety levels and providing substantial relief for individuals with pulmonary fibrosis (PF). Quality of life measured by K-BILD was a key secondary endpoint, with an improvement of 4.4 points compared to the control, and the psychological domain of K-BILD improved by 6.5 points.
The COMPANION study involved 108 participants from across the United States in a randomized, controlled clinical parallel-group study investigating the effects of Almee on psychological symptom burden in adults diagnosed with PF. Living with a life-threatening disease for which there is currently no curative treatment has a negative impact on mental health and quality of life; Almee aims to provide these patients with personalized and accessible psychological support.
“It is very gratifying to see that our tailored, evidence-based CBT intervention in Almee had a clinically meaningful effect for PF patients experiencing anxiety. The results of the COMPANION study demonstrate what can be achieved through a great partnership like the one we had with Vicore Pharma. It is truly groundbreaking, as only a few digital therapies have published such positive results from randomized controlled trials. We have shown that collaborating to design and develop engaging, user-friendly, and patient-focused apps is the best way to collectively change behaviors and improve treatment outcomes for patients.”
John Drakenberg, CEO, Alex Therapeutics
“It is very encouraging to see that a digital CBT shows clear clinical benefit for individuals experiencing the psychological burden associated with pulmonary fibrosis,” said Dr. Maureen Horton, Head of the COMPANION study and Professor of Pulmonary and Critical Care Medicine at the Johns Hopkins University School of Medicine, retired. “Providing behavior-modifying tools that improve quality of life presents a new addition to a comprehensive approach to treating patients suffering from this devastating illness.”
“We are very pleased with these positive results from the COMPANION pivotal study,” said Ahmed Mousa, CEO of Vicore, “and believe that Almee, in combination with molecular therapies, can play a key role in treating individuals suffering from pulmonary fibrosis in a holistic manner.”