The first patient has been enrolled in a U.S. clinical trial evaluating the efficacy and safety of a new artificial intelligence-based app, called Almee, that’s designed to treat anxiety in people with idiopathic pulmonary fibrosis (IPF).
The new clinical trial, called COMPANION (NCT05330312), will be conducted in California. It is expected to enroll up to 270 IPF patients with anxiety, ages 22 and older, to test the effectiveness of the new app. More information on contacts and the study location can be found here.
According to Vicore, the study is planned to start this month and should be completed around March 2023. Depending on the trial’s results, the company may then request Almee’s approval from the U.S. Food and Drug Administration. The Almee app, which was developed in collaboration with the Swedish company Alex Therapeutics, is expected to be available to patients in 2024, if approved by regulators.
“We are very excited to have randomized our first patient in the pilot phase of the COMPANION study,” Maureen Horton, MD, principal investigator of COMPANION, said in a press release.
“This study will not only help to elucidate the effect of anxiety on IPF patients’ quality of life, it will also explore the benefits of cutting edge digital treatment,” said Horton, a professor at Johns Hopkins Medicine.
People with IPF are prone to experiencing anxiety, depression, and other mental health problems which can affect their quality of life. According to Vicore, 63% of people with IPF report a moderate to severe level of anxiety.
Almee was developed under Vicore’s VP04 program, and uses AI, or artificial intelligence, instead of a person, to deliver CBT tailored to patients’ needs. CBT is a psychological treatment designed to identify and correct negative thoughts and beliefs to help patients change the way they feel.
One of the main benefits of the app, according to Vicore, is that it is accessible to patients around the clock for treating anxiety day or night.
The COMPANION trial is a two-part study consisting of a four-week pilot followed by a nine-week pivotal study. In the first part, researchers will determine patient satisfaction with the functionality of Almee, using a semi-structured interview. In the second part, patients will be treated for nine weeks with the app, or will be put in a waitlisted group.
As a primary goal, changes in the Generalized Anxiety Disorder-7 (GAD-7) scale total score will be assessed from baseline, or the trial’s start. The GAD-7 is a test of seven items that was developed to screen for generalized anxiety. It uses a 0–21 scale, with scores of 5–9 indicating mild anxiety and scores of 10–14 indicating moderate anxiety. Scores of 15–21 indicate severe anxiety. To participate in this study, patients must have a total score of five or higher.
The frequency of adverse events while using Almee also will be evaluated.
“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 IPF patient group,” said Jessica Shull, director of digital therapeutics at Vicore.
“This decentralized clinical study also gives us an opportunity to rethink the traditional clinical trial model while keeping the patient in focus,” she added.