First study to utilize digital therapeutics on rare lung disease begins national patient enrollment
CHICAGO, Nov. 29, 2022 /PRNewswire/ -- A first-of-its-kind digital therapeutics research study may offer new hope for patients with a rare lung disease and are having difficulty with anxiety. Vicore Pharma recently launched the study across the U.S.
Pulmonary fibrosis (PF) is a rare disease that is identified by scarring in the lung tissue. The scarring is irreversible and can be progressive, leading to shortness of breath, chronic coughing and often, eventual reliance on supplemental oxygen. Vicore Pharma AB is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe lung diseases.
"PF patients experience higher levels of anxiety, stress and depression compared with the general population," said Andrea Wierzchowski, Ph.D., L.P., a licensed psychologist with a specialty in neuropsychology. "The reasons why relate to the rarity and complexity of the condition, the limited therapies available, the delays and misdiagnoses patients experience and an uncertain future."
Limited access to mental health services — especially during the pandemic — has made the challenge of seeking help more difficult, which is why the Vicore COMPANION Study may be the future of mental health services for people with rare diseases.
"Results from a recent pilot study showed that those who accessed the program demonstrated a nearly 50% decrease in anxiety," said Jessica Shull, director of digital therapeutics at Vicore. "This next phase of the study enables a larger number of patients to participate. It's also the first of its kind to utilize digital therapeutics for a rare lung disease." Because this research is investigational, patients may or may not experience any benefit from participation.
The study is recruiting patients who have been diagnosed with PF at any point and are experiencing significant symptoms of anxiety. According to Wierzchowski, anxiety is an emotion characterized by feelings of persistent and excessive worries that could include physical symptoms, such as:
- Difficulty concentrating
- Feeling irritable, confused or disoriented
- Being unable to fall or stay asleep
- Becoming easily fatigued
- Headaches, muscle aches, stomachaches or unexplained pains
- Racing heart/chest discomfort
- Shallow, rapid breathing/shortness of breath
The Vicore COMPANION Study will test Almee™, a digital cognitive behavioral therapy (CBT). Instead of a therapist, it uses an interactive software. CBT is considered the gold standard in treating anxiety, to inform and guide participants on applying coping skills. What makes the COMPANION Study unique is that it is accessible anywhere — with the use of a smartphone or tablet — enabling people with immunocompromised health to still get the services they need at home. Those who live in rural areas or at a distance from their healthcare center can also easily access the COMPANION Study online. There are no requirements for clinic visits among participants.
The Vicore COMPANION Study, which is overseen by principal investigator Maureen Horton, M.D., lasts for nine weeks.
"Psychosocial interventions and mental health support such as the tools offered in this study can improve quality of life, enabling patients to better manage the daily challenges of living with PF," added Dr. Wierzchowski.
PF patients interested in enrolling in the study can visit: www.VicoreCOMPANIONstudy.com
Vicore Pharma AB (publ) ("Vicore") is a clinical-stage pharmaceutical company, focused on developing innovative medicines in severe lung diseases. The Vicore COMPANION Study will be completed in 2023. Shortly thereafter, Vicore will seek FDA clearance for its platform and make it available to patients in 2024. For more information, visit vicorepharma.com.
CONTACT:
Marita Gomez
630-936-9105
SOURCE Vicore
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