Policy & Regulation
Vicore Pharma launches pivotal phase of COMPANION clinical trial for subjects with pulmonary fibrosis
6 December 2022 -

Vicore Pharma Holding AB (publ), a Sweden-based company involved in the development of angiotensin II type 2 receptor agonists (ATRAGs), announced on Monday that it has introduced the pivotal phase of COMPANION, the first clinical investigation of a digital cognitive behavioural therapy (dCBT) for subjects with pulmonary fibrosis.

The COMPANION study, a fully digitalised, randomised, controlled parallel-group clinical investigation, is intended to assess the effect of the digital therapy Almee on the psychological symptom burden in adults diagnosed with pulmonary fibrosis (PF). It is enrolling 250 patients across the United States and is scheduled for completion in the fourth quarter of 2023.

Almee will be submitted to the FDA for approval as a prescription medical device to be introduced in 2024 with the aim to treat the anxiety symptoms in patients with pulmonary fibrosis if the outcome is positive.

Jessica Shull, Vicore director of Digital Therapeutics, said, 'Almee is an integral part of the Vicore development strategy for holistic and personalised treatment for rare lung disease and it addresses a clear unmet need in the PF population. This decentralised clinical investigation also gives us an opportunity to rethink the traditional clinical trial model while keeping the patient in focus.'