Vicore announces first patient enrolled in COMPANION; a digital therapeutic pivotal study for patients with pulmonary fibrosis

2022-12-05

• First randomized clinical investigation with a digital therapy (DTx) to address the psychological symptom burden in pulmonary fibrosis (PF) patients
• First patient enrolled in US pivotal study; readout expected Q4 2023
• Supports development of a strong holistic portfolio in rare lung disease

Stockholm, December 5, 2022 – Vicore Pharma Holding AB (publ) (“Vicore”), a pioneer in the development of angiotensin II type 2 receptor agonists (ATRAGs), today 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 anxiety¹. 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.

“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 study² 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

For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com

This information was submitted for publication on December 5, 2022 at 08:15 CET.

About Almee^TM, Vicore’s digital therapeutic in pulmonary fibrosis (PF)
Almee^TM (an investigational medical device pending FDA clearance) is a digital therapeutic (DTx) based on cognitive behavioral 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.