Vicore Pharma Holding AB, a pioneer in the development of angiotensin II type 2 receptor agonists (ATRAGs), has announced the launch of its pivotal phase of COMPANION.
It is the first clinical investigation of a digital cognitive behavioral therapy (dCBT) for patients with pulmonary fibrosis.
Patients with pulmonary fibrosis (PF) are given a poor prognosis, during which dyspnea, fatigue and cough gradually worsen. In a preceding study, it was shown that 63% of PF patients report treatable levels of anxiety. Vicore's digital Cognitive Behavioral Therapy has the advantage of being accessible 24/7 and can be personalized to meet the patient's individual needs and schedule.
As per the news report, the COMPANION study is a ‘fully digitalized, randomized, controlled parallel-group clinical investigation to evaluate the impact of the digital therapy Almee on the psychological symptom burden in adults diagnosed with PF. Patients enrolled in the investigation will be randomized to Almee or a treatment-as-usual control group, for nine weeks. Outcomes will be patient- and clinician-reported measures of anxiety using validated questionnaires.’
The COMPANION study, which is enrolling 250 patients across the US, is scheduled to complete in Q4 of 2023.
Provided the result is positive, Almee will be submitted for FDA clearance as a prescription medical device to be launched in 2024 with the intention to treat anxiety symptoms in patients with pulmonary fibrosis.
Join the HealthXL Masterclass on the ‘Future EU Regulations for AI in Medical Devices’ on 13th December. Click here to Request to Join.
Click here to read the original news article.