MetaMedical™ Solutions Inc

Anxiety app trial hits primary endpoint in pulmonary fibrosis patients

Swedish-based Alex Therapeutics has announced that its clinical trial of cognitive behavioural therapy (CBT) delivered via an app intended to address anxiety has met its primary endpoint.

The Almee is a mobile phone and tablet app, which is intended to offer personalised treatment for patients living with anxiety, with the aim to improve user’s overall quality of life by lowering their anxiety levels.

The app is developed alongside the clinical-stage pharmaceutical firm Vicore Pharma.

Alex Therapeutics has announced that its pivotal COMPANION trial was able to lower reported anxiety scores in patients living with pulmonary fibrosis (PF), meeting its primary endpoint of lowering anxiety levels following the app’s nine-week therapy course.

The randomised, controlled, parallel-group COMPANION study enrolled 108 participants at sites across the United States. The trial examined if the nine-week course of the app could be used to lower the general anxiety levels of patients living with PF.

Using the Generalized Anxiety Disorder Seven Item (GAD-7) anxiety score system as the primary endpoint, the trial was able to achieve a 2.7-point improvement compared to the control, with a change of more than 1.8 being considered clinically meaningful.

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By GlobalData

The GAD-7 system rates a patient’s anxiety on a scale of zero to 21, covering four major levels of anxiety. As there is no current curative treatment for PF, the trial’s secondary endpoint additionally seeks to improve the overall quality of life for those living with the condition.

Principal investigator Maureen Horton said: “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.”

Research published by GlobalData details how the telemedicine and virtual care market has seen a significant leap in terms of usage and value since the Covid-19 pandemic, with the market having been worth $690m in 2015, but set to reach $3.8bn by 2030 with mental health expected to be its primary area of growth.

Additionally, the report showed that 2023 saw the entrance of 257 new devices into the market, a significant increase over the 71 telehealth products released in 2021. Whilst the majority of these applications are intended for the mobile phone and tablet device market, telemedicine apps have also found a home in the burgeoning field of wearable tech, with the advent of the VR headset.

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