Vicore Pharma DTx helps pulmonary fibrosis patients

A digital therapeutic developed by Vicore Pharma and Alex Therapeutics has been shown to reduce the psychological burden of living with pulmonary fibrosis (PF) in a pivotal trial.

The cognitive behavioural therapy (CBT)-based treatment – called Almee (formerly VP04) – significantly reduced anxiety in patients with PF in the COMPANION study involving 108 patients with the progressive and life-threatening disease.

Patients with idiopathic pulmonary fibrosis (IPF) have an average life expectancy of just three to five years, during which time symptoms like cough, fatigue, and shortness of breath get worse, and around two-thirds of them report moderate to severe anxiety.

Almee takes the form of a nine-week CBT course delivered using a smartphone or tablet, designed to help patients understand and manage their condition better and break the cycle of feelings that lead to anxiety and fear.

In COMPANION, the digital therapeutic (DTx) met its primary endpoint with a statistically significant 2.7-point reduction in anxiety score – measured using the GAD-7 scale – over the course of four weeks’ follow-up. That is a smaller benefit than was seen in an earlier, smaller pilot study, but above the 1.8-point reduction that Vicore and Alex say is considered "clinically meaningful."

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). A 2.7-point reduction corresponds to “tangible relief” for patients with PF, according to the investigators, and was accompanied by improvements in quality of life measured using the K-BILD scale.

“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’s principal investigator Dr Maureen Horton, formerly professor of pulmonary and critical care medicine at Johns Hopkins University School of Medicine and now retired.

“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,” she added.

Vicore – a specialist in respiratory disease therapies – joined forces with Alex in 2022 to develop the DTx, securing all rights to the therapy in exchange for an upfront payment of around $1 million, plus potential milestones and royalties.

The company says it plans to present full results from the COMPANION study at a conference later this year and further develop the DTx “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.”