- First clinical study with digital therapy (DTx) in patients with IPF to address the psychological symptom burden of this disease
- First patient enrolled in the US pilot phase leading to the US pivotal phase of the study with an expected start in H2 2022
- DTx aims to be part of a differentiated offer in rare lung diseases
GOTHENBURG, Sweden, April 21, 2022 /PRNewswire/ — Vicore Pharma Holding AB (publ) (“Vicore”), a clinical-stage pharmaceutical company, today announces the first patient enrolled in the pilot phase of COMPANION1a clinical study of a digital cognitive behavioral therapy for patients with IPF.
Patients with IPF have a life expectancy of three to five years, during which dyspnoea, fatigue and cough gradually worsen and in a previous study it was shown that 63% of patients with IPF report a moderate to severe level of anxiety.2. Cognitive-behavioral therapy (CBT) is a well-established method of helping patients suffering from the psychological burden caused by serious illness and digital CBT has the advantage of being accessible 24 hours a day and can be customized to meet needs. of the patient.
COMPANION is a fully digitized, randomized, parallel-group controlled clinical study to assess the impact of Almee™ digital therapy on psychological symptom burden in adults diagnosed with IPF. The COMPANION study consists of two phases; a pilot study to refine the interactive nature of the therapy session, followed by a pivotal study. The study will take place in the United States and is expected to be completed in the first half of 2023, after which Vicore will seek FDA clearance for Almee™ as a medical device and is expected to be available to patients in 2024. Almee™ is developed in collaboration with Alex Therapeutics AB* and the COMPANION study is conducted using virtual clinical solutions developed by Curebase Inc*.
“We are very pleased to have randomized our first patient into the pilot phase of the COMPANION study. This study will not only help elucidate the effect of anxiety on the quality of life of patients with IPF, but will also explore the advantages of state-of-the-art digital processing,” says the teacher Maureen HortonCOMPANION Principal Investigator, Johns Hopkins University.
“Almee™ is an integral part of Vicore’s development strategy for the holistic and personalized treatment of rare lung diseases and addresses a clear unmet need in the IPF patient group. This decentralized clinical study also gives us the opportunity to rethink the traditional clinical trial model while keeping the patient at the center of our concerns,” said Jessica HullDirector of Digital Therapeutics at Vicore.
For more information, please contact:
Carl Johan DalsgaardCEO
Telephone: +46 70 975 98 63
E-mail: [email protected]
About Digital Therapy (DTx)
DTx products are clinically evaluated software, designed, built and tested to treat a disease or condition. DTx are medical devices and are subject to medical device regulations in the country of use. DTx products can be standalone software or used in conjunction with another therapy. As the interest in DTx of pharmaceutical companies and healthcare professionals have grown, authorities Europe and elsewhere have developed new evaluation frameworks, requiring digital therapies to be demonstrated to be clinically safe and effective before regulatory approval..
About AlmeeMTVicore’s digital therapeutics in IPF
AlmeaMT (an investigational medical device pending FDA clearance) is a digital therapy (DTx) based on cognitive-behavioral therapy (CBT) to address the psychological impact of living with IPF. Vicore collaborates with Alex Therapeutics for the development of this medical device product3. AlmeaMT will be evaluated through pilot and real-world clinical studies as well as secure regulatory approvals in accordance with national and international medical device development standards.
This information was submitted for publication on April 21, 2022 to 09:30 CET.
*For more information, see Alex Therapeutic AB and Curebase Inc. websites.
2. Vicore data on file
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SOURCE Vicore Pharma Holding AB