Alex Therapeutics and Vicore Pharma today 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.
Image Credit: Alex Therapeutics
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. 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, 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 life; the aim of Almee is to provide personalized and accessible psychological support for these patients.
It’s very rewarding to see that our tailored, evidence-based CBT intervention in Almee had a clinically meaningful impact for PF patients suffering from anxiety. The results of the COMPANION study demonstrate what can be achieved through a great partnership like the one we’ve had with Vicore Pharma. It’s really groundbreaking, with so few digital therapies having published such positive randomized controlled trial results to date. We’ve shown how partnering to design and develop engaging, user-friendly, patient-facing apps is the best way to work together to change behavior and improve patient outcomes.”
John Drakenberg, CEO, Alex Therapeutics
“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 suffering from this devastating disease.”
“We’re so pleased to see these positive results in the COMPANION pivotal study,” said Ahmed Mousa, Chief Executive Officer of Vicore, “and believe that Almee can play a key role in combination with molecular therapies to address individuals suffering from pulmonary fibrosis in a holistic way.”
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