Vicore Pharma’s DTx to benefit pulmonary fibrosis patients

The nine-week DTxl CBT helps to address psychological symptom burdens in PF patients

Vicore Pharma has announced positive results for its digital cognitive behavioural therapy (CBT), AlmeeTM, to help address the psychological symptom burdens in patients living with pulmonary fibrosis (PF).

Developed in partnership with Alex Therapeutics, AlmeeTM is a nine-week digital CBT that can be accessed via a smartphone or tablet and aims to provide personalised and accessible psychological support for PF patients.

Affecting around 100,000 people in the US, idiopathic PF (IPF) is a severe and life-threatening disease in which the lungs become scarred and breathing becomes increasingly difficult.

Involving 108 US patients living with PF, the COMPANION trial, has been investigating the efficacy of the digital therapeutic (DTx) on the psychological symptom burden in adults diagnosed with the disease.

The trial met its primary endpoint with a statistically significant 2.7 reduction in anxiety score, including a change in GAD-7 of more than 1.8 points, reducing anxiety levels and offering relief.

The GAD-7 is widely used in clinical practice to assess anxiety by scoring ranges from zero to 21, with four levels that span from minimal anxiety to severe anxiety.

In addition, measured using the K-BILD scale, quality of life was a key secondary outcome in the trial, which improved by 4.4 points compared to the control and the K-BILD psychological domain improved by 6.5 points.

Dr Maureen Horton, principal investigator and retired professor of pulmonary and critical care medicine at Johns Hopkins University School of Medicine, said: “Providing behaviour-modifying tools that enhance quality of life represents a new addition to a comprehensive treatment approach for patients living with this devastating disease.”

Ahmed Mousa, chief executive officer, Vicore, believes that “Almee can play a key role in combination with molecular therapies to address the suffering of individuals with PF in a holistic way”.

Vicore aims to present the full results from the trial at a conference this year and will seek to advance AlmeeTM in partnership with the developers of approved and late-stage molecular therapies to treat PF.