Almee digital app shows promise in lowering anxiety in PF patients

COMPANION study assessed app's ability to address psychological burden of PF

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by Mary Chapman |

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Almee, an investigational app that offers personalized treatment to help people with pulmonary fibrosis (PF), was found to significantly reduce anxiety levels in PF patients who participated in a pivotal randomized study.

Positive results from the COMPANION (NCT05330312) study were announced by Alex Therapeutics and Vicore Pharma, which are jointly developing the app, a digital cognitive behavioral therapy (CBT) intervention that can be accessed through a smartphone or tablet.

“It’s very rewarding to see that our tailored, evidence-based CBT intervention in Almee had a clinically meaningful impact for PF patients suffering from anxiety,” John Drakenberg, Alex Therapeutics’ CEO, said in a company press release. “The results of the COMPANION study demonstrate what can be achieved through a great partnership like the one we’ve had with Vicore Pharma. It’s really groundbreaking, with so few digital therapies having published such positive randomized controlled trial results to date.”

COMPANION met its primary goal — an assessment of the ability of Almee, the first digital treatment to address the psychological burden of living with PF, to mitigate anxiety — as gauged by a drop in the scores of the Generalized Anxiety Disorder (GAD)-7 scale.

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Promising scores with Aimee use

In patients treated with Almee, there was a 2.7-point improvement in GAD-7 scores from the study’s start (baseline) compared with controls. A GAD-7 score change exceeding 1.8 is considered clinically meaningful. Scoring for the GAD-7 scale, commonly used clinically as an anxiety assessment tool, ranges from 0 to 21, with four levels representing minimal anxiety (0 to 4) to severe (15 to 21). The 2.7-score improvement shows Almee has “promising efficacy” in lowering anxiety levels in patients, according to Alex.

Patient life quality, a key secondary goal in the study, improved by 4.4 points, as measured by King’s Brief Interstitial Lung Disease (KBILD), a 15-item validated health-related quality of life questionnaire. There was also a 6.5-point improvement in the KBILD psychological domain.

“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 individuals suffering from pulmonary fibrosis in a holistic way,” Ahmed Mousa, Vicore’s CEO, said.

Vicore said it plans to present full results from the COMPANION study at a conference this year and to seek to advance Almee, which uses interactive and artificial intelligence-based software, by partnering with developers of approved and late-stage molecular PF treatments. Vicore previously stated that if the findings were positive, it would ask the U.S. Food and Drug Administration to clear Almee for launch this year as a prescription medical device for patients with anxiety symptoms.

What is the COMPANION study?

The COMPANION study, which enrolled its first patient in late 2022, included 108 U.S. participants, ages 22 and older, who had anxiety. It required no clinical visits and was conducted in two parts, with the app used for four weeks in the first part, during which Almee’s functionality was assessed through patient interviews. The second part saw patients randomly and equally assigned to a therapy or control group for nine weeks.

Patients in the therapy group engaged in daily 10-minute sessions in addition to questionnaires using the U.S. online platform Curebase, with suggested activities. Control participants completed questionnaires and were to be offered access to Almee after the study concluded.

In addition to progressive lung tissue damage, which can lead to needing supplemental oxygen, PF can provoke mental health issues, such as anxiety, that can impact patients’ quality of life.

Developed under Vicore’s VP04 program, the digital CBT is designed to identify and correct negative thoughts and help patients change how they feel. According to data from a pilot study, the app, which offers around-the-clock accessibility and can be tailored to meet each user’s needs, could reduce anxiety by about half.

“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 Maureen Horton, MD, principal investigator for the COMPANION study and retired professor of pulmonary and critical care medicine at Johns Hopkins University School of Medicine. “Providing behavior-modifying tools that enhance quality of life represents a new addition to a comprehensive treatment approach for patients suffering from this devastating disease.”

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