Vicore Pharma begins patient enrolment in COMPANION study to treat pulmonary fibrosis

Vicore Pharma Holding AB, a pioneer in the development of angiotensin II type 2 receptor agonists (ATRAGs), launched the pivotal phase of COMPANION, the first clinical investigation of a digital cognitive behavioural therapy (dCBT) for patients with pulmonary fibrosis. Patients with pulmonary fibrosis (PF) are given a poor prognosis, during which dyspnoea, 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 Behavioural Therapy has the advantage of being accessible 24/7 and can be personalized to meet the patient's individual 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," says Dr. Josh Solomon, MD of National Jewish Health, Denver, Colorado and CIinical Investigator of the study. 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, enrolling 250 patients across the US, is scheduled to complete in Q4 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 the anxiety symptoms in patients with pulmonary fibrosis. "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.

This decentralized clinical investigation 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. Almee (an investigational medical device pending FDA clearance) is a digital therapeutic (DTx) based on cognitive behavioural therapy (CBT) created to address the psychological impact of living with PF. Vicore is collaborating with Alex Therapeutics for the development of this medical device product.