Patient App to Ease Anxiety Enters Testing in Pivotal Phase of Study

1st PF patient enrolled to test Almee, which uses interactive software to help users

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by Patricia Valerio, PhD |

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Vicore Pharma has launched the pivotal part of its COMPANION study to test Almee, a digital app designed to help people with pulmonary fibrosis (PF) cope with anxiety.

Almee is a digital cognitive behavioral therapy (CBT) developed by Vicore in collaboration with Alex Therapeutics. It uses interactive and artificial intelligence-based software to help users ease their anxiety. 

COMPANION (NCT05330312) is the first randomized clinical study with a digital CBT to address this psychological symptom in PF patients.

The study, which recently started recruiting, has enrolled its first patient and expects to recruit up to 260 PF patients, 22 and older, who experience anxiety. It’s due to conclude in the fourth quarter of 2023. No clinical visits will be required over the course of the study, and participation will be compensated.

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Pending study results, Vicore plans to submit request to US regulators

If the findings are positive, Vicore is planning to submit a request to the U.S. Food and Drug Administration that the therapy be cleared as a prescription medical device to be launched in 2024 as a treatment for anxiety symptoms in PF patients.

“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,” Jessica Shull, PhD, Vicore’s director of digital therapeutics, said in a press release

PF is characterized by progressive lung tissue damage, leading to shortness of breath, chronic cough, fatigue, and in some cases, the need for supplemental oxygen. 

In addition, patients can experience a poor prognosis, with symptoms gradually worsening. These patients are at higher risk of experiencing mental health challenges — anxiety, depression, and other problems — which can affect their quality of life.

Almee is developed under Vicore’s VP04 program. As a digital CBT, it seeks to identify and correct negative thoughts and help patients alter how they feel. Data from a pilot study showed the app could decrease anxious feelings by about half.

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

Almee is accessible 24/7 from anywhere through a smartphone or tablet, and it can be personalized to meet each patient’s needs and schedule.

“Continuous access is important when providing psychological support for patients who have anxiety about leaving their homes due to the risk of infection or limitations due to their disease,” said Josh Solomon, MD, pulmonologist at National Jewish Health, in Denver, Colorado, and the study’s clinical investigator.

COMPANION is a pivotal study to test the efficacy and safety of Almee for PF patients with anxiety. Its main goal is to assess the therapy’s ability to lessen anxiety, as measured by a decrease in the scores of the Generalized Anxiety Disorder-7. Secondary goals include evaluating changes in anxiety severity, occurrence of adverse effects, and improvements in health-related quality of life.

The study is divided into two parts. In the first part, enrolled participants use the app for four weeks. During this phase, the therapy’s functionality is evaluated based on patient interviews.

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Pivotal phase will test effect of using app on patient’s anxiety

For the second part, patients will be randomly and equally assigned to a therapy or control group for another nine weeks.

Patients assigned to digital CBT therapy will engage in daily 10-minute sessions plus questionnaires with suggested activities, whereas controls will complete questionnaires and be offered access to the app after the study’s completion.

Questionnaires will be completed using the online platform from Curebase, a U.S. company running the study on behalf of Vicore.

“This decentralized clinical investigation also gives us an opportunity to rethink the traditional clinical trial model while keeping the patient in focus,” Shull said.

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