App for anxiety in PF wins FDA breakthrough device designation

Interactive behavioral therapy app is 1st aimed at PF patients

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Almee, a behavioral therapy app designed to help ease anxiety in people with pulmonary fibrosis (PF), has been granted breakthrough device designation by the U.S. Food and Drug Administration (FDA).

The FDA gives this designation to medical devices that have the potential to provide a more effective treatment or diagnosis of serious and life-threatening conditions. The idea is to allow patients and healthcare professionals access to new medical devices faster by speeding the development and regulatory review process.

The designation “reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis, and demonstrates the impactful nature of this digital therapy,” according to Vicore Pharma, which developed Almee alongside Alex Therapeutics.

“Breakthrough designation sets Almee apart as an innovative and effective tool for PF patients, and it supports our ambition to help patients with pulmonary fibrosis by improving quality of life,” Ahmed Mousa, CEO of Vicore, said in a company press release.

Almee is based on cognitive behavioral therapy, a type of psychological therapy that focuses on breaking negative thought patterns. The interactive software was developed to provide emotional support tailored to suit a patient’s individual needs, according to Vicore.

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Add-on treatment for anxiety in PF

The FDA designation covers the app’s use as an adjunct, or add-on, treatment to help PF patients manage anxiety.

“Almee represents the future of healthcare, and is poised to deliver significant patient impact as an example of innovation in digital-molecular combination therapies,” said Jessica Shull, PhD, director of digital health at Vicore.

In January, Vicore and Alex announced positive results from the COMPANION study (NCT05330312) evaluating the safety and efficacy of the digital therapy in a group of PF patients.

The study enrolled 108 adults with PF and clinically relevant anxiety. Participants were randomly assigned to use Almee in 10-minute sessions daily for nine weeks or to a control group that didn’t use the app.

Patients who used the app reported significantly less anxiety, with a 2.7-point improvement relative to controls on the Generalized Anxiety Disorder-7 scale. Patients who used Almee also reported significantly better quality of life than controls, according to Vicore. The company plans to present full results from the study at a scientific conference this year.

Vicore said it’s looking to partner with developers of approved and late-stage molecular therapies to further advance the app.