Stockholm, April 21, 2022 - Alex Therapeutics, a Digital Therpautics (DTx) Software as a Medical Device (SaMD) manufacturer, today announces the first patient enrolled in the pilot phase of the COMPANION clinical study of a digital cognitive behavioral therapy for patients with PF.
- The DTx, Almee, under clinical study was built on Alex Therapeutics proprietary “Alex DTx Platform”
- First clinical study with a digital therapy (DTx) in patients with PF to address the psychological symptom burden in this disease
- First patient enrolled in US pilot phase leading up to US pivotal phase of the study
- The DTx is developed by Alex Therapeutics in collaboration with Vicore Pharma (”Vicore). Vicore is responsible for the clinical validation and commercialisation of the DTx
"We are very excited to have randomized our first patient in the pilot phase of the COMPANION study. This study will not only help to elucidate the effect of anxiety on PF patients’ quality of life, it will also explore the benefits of cutting edge digital treatment."
- Professor Maureen Horton, principal investigator of COMPANION, Johns Hopkins University.
Patients with PF have a life expectancy of three to five years, during which dyspnea, fatigue and cough gradually worsen and in a preceding study, it was shown that 63% of IPF patients report a moderate to severe level of anxiety. Cognitive behavioral therapy (CBT) is a well-established method to help patients with the psychological burden caused by severe disease and a digital CBT has the advantage of being accessible around-the-clock and can be personalized to meet the patient’s needs.
“We’re excited to have begun the first the first step in clinically validating our Digital Therapeutic for PF patients. This clinical pilot study, conducted using a decentralized clinical trial model, will provide invaluable clinical insights ahead of the larger pivotal phase of the study. Its been a pleasure working with Vicore and Curebase in launching this study and we look forward to continuing our collaboration.”
- John Drakenberg Renander, CEO at Alex Therapeutics
COMPANION is a fully digitalized, randomized, controlled parallel-group clinical study to evaluate the impact of the digital therapy Almee on the psychological symptom burden in adults diagnosed with PF. The COMPANION study consists of two phases; a pilot study designed to refine the interactive nature of the therapy session, followed by a pivotal study. The study will take place in the US and is expected to conclude in H1 2023, after which Alex will seek FDA clearance for Almee as a medical device and is expected to be made available to patients in 2024. Almee has been developed by Alex Therapeutics in collaboration with Vicore Pharma, who are responsible for leading the clinical validation of the DTx and the subsequent commercialisation. The COMPANION study is conducted using virtual clinical solutions developed by Curebase Inc.
“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 patient group. This decentralized clinical study also gives us an opportunity to rethink the traditional clinical trial model while keeping the patient in focus”
- Jessica Shull, Director of Digital Therapeutics at Vicore.