VICORE PHARMA HOLDING AB - The COMPANION pivotal study met the primary endpoint and demonstrated significantly reduced anxiety in patients with pulmonary fibrosis.
- AlmeeTM is the first digital therapy to address the psychological symptom burden of living with pulmonary fibrosis.
The study met its primary endpoint, change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement of anxiety symptoms in the group treated with Almee compared to control, where a change in GAD-7 score of more than 1.8 points is considered clinically meaningful[1]. The GAD-7 scale is widely used in clinical practice as an assessment tool for anxiety; scoring ranges from 0 to 21 with four levels spanning minimal anxiety (0 to 4) to severe (15 to 21). The observed 2.7-point improvement reflects promising efficacy in reducing anxiety levels and offering tangible relief to individuals coping with pulmonary fibrosis (PF). Quality of life, measured by the K-BILD[2], was a key secondary endpoint and improved by 4.4 points compared to control, and the K-BILD psychological domain improved by 6.5 points.
The COMPANION study enrolled 108 participants from across
“It is very encouraging to see a digital CBT demonstrating a clear clinical benefit for individuals suffering from the mental health burden that accompanies pulmonary fibrosis,” said COMPANION study Principal Investigator Dr.
“We’re so pleased to see these positive results in the COMPANION pivotal study,” said
Vicore plans to present full results from the COMPANION study at a conference in 2024. The company will seek to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis, spearheading the continued development of innovation in improved therapy with software-molecular combination therapies.
Almee is subject to medical device regulation in
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About
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
About Alex Therapeutics
Alex Therapeutics, a digital health company, partners with pharmaceutical companies to help patients with disease and treatment-specific challenges through clinically validated apps. With its proven, scalable technology platform, as well as expertise in patient-centric design and evidence-based behavior change, Alex Therapeutics treats patients and supports healthcare professionals globally. Alex Therapeutics, alongside its partners, has extensive experience in multi-jurisdiction Software-as-a-Medical-Device (SaMD) regulatory processes, including CE and FDA approval, as well as clinical evidence generation for SaMDs. For more information, visit www.alextherapeutics.com
[1] Kounali D, Button KS, Lewis G, Gilbody S, Kessler D, Araya R, Duffy L, Lanham P, Peters TJ, Wiles N,
[2] King’s Brief Interstitial Lung Disease (KBILD) is a 15-item validated health-related quality of life (HRQOL) questionnaire. Nolan CM, Birring SS, Maddocks M, Maher TM, Patel S, Barker RE, Jones SE, Walsh JA, Wynne SC, George PM, Man WD. King's Brief Interstitial Lung Disease questionnaire: responsiveness and minimum clinically important difference. Eur Respir J. 2019
[3] Yohannes, AM (2020) Depression and anxiety in patients with interstitial lung disease, Expert Review of Respiratory Medicine, 14:9, 859-862, DOI: 10.1080/17476348.2020.1776118
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