Vicore’s lung disease digital therapy gets breakthrough tag


Swedish pharma company Vicore has won breakthrough status from the FDA for Almee, a cognitive behavioural therapy (CBT) app used to support people with pulmonary fibrosis (PF).

Almee takes the form of a nine-week CBT course that has been shown in clinical testing to reduce the psychological burden of living with PF, a progressive and life-threatening disease with an average life expectancy for patients of just three to five years. It is being developed in association with digital health specialist Alex Therapeutics.

The FDA’s breakthrough device designation can speed up the development of new medical devices and digital health technologies, becoming eligible for a prioritised review, which can sometimes result in shorter development and review times.

In the pivotal COMPANION trial reported earlier this year, Almee achieved a statistically significant 2.7-point reduction in anxiety score – measured using the GAD-7 scale – over the course of four weeks’ follow-up.

A 2.7-point reduction corresponds to “tangible relief” for patients with PF, according to the study investigators, who also found a 4.4-point improvement in KBILD total score, a scale that looks at quality of life.

Anxiety is common in people with PF, reflecting the fact that current treatments can only slow down the progression of the disease, which affects around 250,000 people in the US alone. Symptoms of the disease include cough, fatigue, and shortness of breath, which get more debilitating and distressing over time.

It is estimated that around two-thirds (60%) of PF patients experience anxiety, which Almee tries to alleviate by helping patients understand and manage their condition better and break the cycle of feelings that lead to anxiety and fear.

Vicore said in a statement that the breakthrough status “reflects the effectiveness of [Almee] compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy.”

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

The Swedish company says it plans to present full results from the COMPANION study at a conference later this year and is looking for partnerships with the developers of “approved and late-stage” molecular therapies for PF.

Late-stage development candidates for PF – all vying to be first-in-class treatments – include Bristol-Myers Squibb’s LPA1 antagonist BMS-986278, Boehringer Ingelheim’s PDE4B inhibitor BI 1015550, and Pliant Therapeutics’ αvß6 and αvß1 integrin inhibitor bexotegrast.