The pilot phase of a clinical study reports positive results with digital therapeutic treatment for anxiety in patients with idiopathic pulmonary fibrosis (IPF).
A 4-week, open-label, decentralized, single-arm clinical trial was conducted in 10 patients with IPF-related anxiety. The primary study objective was to evaluate the functionality, user experience, and safety of the digital therapeutic—developed by Alex Therapeutics in conjunction with Vicore Pharmaceuticals—with all results reported as positive.
Encouraging early indicators of efficacy were observed in the pilot study as well. Findings from the analysis showed the patient-reported generalized anxiety disorder (GAD-7) average score to be reduced by 4.2 points (which is considered a 49% reduction)—with a decrease in GAD-7 score of more than 2 points regarded as “clinically meaningful.” The GAD-7 is a self-administered patient questionnaire that is used as a screening tool and severity measure among individuals with GAD.
“We’re pleased with these results and working with Alex; co-collaboration on a digital therapeutic is complex but it has been a successful partnership. We look forward to the pivotal phase [of the study] and [to] being one step closer to providing another resource for people with PF,” said Jessica Shull, head of digital therapeutics at Vicore.
The pivotal phase of the study will begin in the fourth quarter of 2022. At that time, the full digital therapeutic, known as Almee™, will go through a US-based, 9-week, randomized, controlled, parallel-group decentralized clinical evaluation with 250 patients with all types of pulmonary fibrosis.
The researchers noted that, “These results, together with the safety, functionality, and user experience indications, suggest that the digital therapeutic could serve as a reliable resource for addressing the psychological impact of living with IPF.”
Alex Therapeutics presents results from digital therapeutics pilot study showing nearly 50% reduction in anxiety. New release. Alex Therapeutics; October 13, 2022.