COMPANION study of digital therapy demonstrates reduced anxiety in patients with pulmonary fibrosis

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Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced positive results of the COMPANION study (NCT05330312), investigating the efficacy of AlmeeTM, a 9-week digital cognitive behavioral therapy (CBT) 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 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. 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 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 life; 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.”

We’re so pleased to see these positive results in the COMPANION pivotal study,  and believe that Almee can play a key role in combination with molecular therapies to address the suffering of individuals with pulmonary fibrosis in a holistic way.”

Ahmed Mousa, Chief Executive Officer, Vicore

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.

Almee is subject to medical device regulation in the United States and Europe and is developed in partnership with Alex Therapeutics.

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