Trial Begins Testing Digital Therapy for Anxiety with Lung Disease

Almee smartphone app (Alex Therapeutics)

5 Dec. 2022. A clinical trial is underway testing a mobile app designed to help people with a serious lung disorder manage anxiety that often accompanies the disease. The Almee app tested in the trial is made by digital behavioral therapy company Alex Therapeutics in Stockholm, Sweden, with drug maker Vicore Pharma Holding, also in Stockholm.

Alex Therapeutics is a creator of mental health therapy software to treat behavioral conditions often found in people with serious physical disorders. The company works with pharmaceutical companies developing treatments for diseases where patients in many cases also must overcome psychological conditions preventing full recovery. One of those disorders is pulmonary fibrosis, a condition affecting older adults where lung tissue becomes scarred, making breathing more difficult, and resulting in shortness of breath and a persistent dry cough. Up to now, treatments are designed to slow progression of the disease or relieve patients’ symptoms.

Vicore Pharma is developing treatments to repair lung tissue damaged by pulmonary fibrosis and other respiratory diseases including Covid-19, with the company’s lead product in a mid-stage clinical trial. But Vicore Pharma also recognizes the mental health effects on people with pulmonary fibrosis or PF, and in May 2021 began a collaboration with Alex Therapeutics to develop a digital companion therapy to address the anxiety in a large percentage of people with the disease, 63 percent according to data cited by Vicore.

“Almee is an integral part of the Vicore development strategy for holistic and personalized treatment for rare lung disease and it addresses a clear unmet need in the PF population,” says Jessica Shull, director of digital therapeutics at Vicore Pharma, in a company statement released through Cision.

Four-week pilot test

Under their agreement, Alex Therapeutics is developing the Almee mobile app, using cognitive behavioral therapy to help relieve anxiety, which Vicore plans to offer as one of its treatments for pulmonary fibrosis. Cognitive behavioral therapy or CBT is a type of psychotherapy where clinicians help individuals identify and verbalize harmful thoughts and actions, then guide patients with actions for developing healthier behaviors. The companies say the app is designed for use by older adults.

The clinical trial is enrolling a total of 260 people diagnosed with pulmonary fibrosis at a clinical study site in San Francisco. Participants are receiving their usual treatments for pulmonary fibrosis, but patients are then randomly assigned to also use or not use the Almee app. The first part of the trial is a four-week therapy program designed as an initial pilot test of the app’s safety and feasibility with 10 participants. In the pilot test and full nine-week program that follows, the study team is looking primarily at scores on a standard seven-item generalized anxiety disorder scale, as well as other measures of anxiety, quality of life, and signs of adverse effects.

In October, Alex Therapeutics reported on results of the trial’s four-week pilot test. The company says the findings show an average reduction of 4.2 points on the generalized anxiety disorder scale, where a decline of two or more points is considered “clinically meaningful.” Vicore Pharma and Alex Therapeutics say the first of 250 participants is now enrolled in the full nine-week assessment of the Almee app.

Oliver Fleetwood, chief technology officer and co-founder of Alex Therapeutics says in a company statement, “This is a major step in helping to alleviate the psychological burden of PF patients and we look forward continuing to bring innovative digital therapeutics to market.”

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