Vicore Pharma Holding AB today announces the first patient enrolled in the pilot phase of COMPANION1, a clinical study of a digital cognitive behavioral therapy for patients with IPF.
Patients with IPF have a life expectancy of three to five years, during which dyspnea, fatigue and cough gradually worsen and in a preceding study, it was shown that 63% of IPF patients report a moderate to severe level of anxiety2. Cognitive behavioral therapy (CBT) is a well-established method to help patients with the psychological burden caused by severe disease and a digital CBT has the advantage of being accessible around-the-clock and can be personalized to meet the patient’s needs.
COMPANION is a fully digitalized, randomized, controlled parallel-group clinical study to evaluate the impact of the digital therapy Almee™ on the psychological symptom burden in adults diagnosed with IPF. The COMPANION study consists of two phases; a pilot study designed to refine the interactive nature of the therapy session, followed by a pivotal study. The study will take place in the US and is expected to conclude in H1 2023, after which Vicore will seek FDA clearance for Almee™ as a medical device and is expected to be made available to patients in 2024. Almee™ is developed in collaboration with Alex Therapeutics AB* and the COMPANION study is conducted using virtual clinical solutions developed by Curebase Inc*.
“We are very excited to have randomized our first patient in the pilot phase of the COMPANION study. 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,” says Professor Maureen Horton, principal investigator of COMPANION, Johns Hopkins University.
“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. This decentralized clinical study also gives us an opportunity to rethink the traditional clinical trial model while keeping the patient in focus,” says Jessica Shull, Director of Digital Therapeutics at Vicore.