Vicore Pharma Holding AB (publ) ("Vicore") launched the pivotal phase of COMPANION, 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. The COMPANION study is a fully digitalized, randomized, controlled parallel-group clinical investigation to evaluate the impact of the digital therapy Almee(TM) on the psychological symptom burden in adults diagnosed with PF. Patients enrolled in the investigation will be randomized to Almee(TM) 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, enrolling 250 patients across the US, is scheduled to complete in fourth quarter 2023. Provided the result is positive, Almee(TM) will be submitted for FDA clearance as a prescription medical device to be launched in 2024 with the intention to treat the anxiety symptoms in patients with pulmonary fibrosis.