Stockholm, April 21, 2022 - Alex Therapeutics, a Digital Therpautics (DTx) Software as a Medical Device (SaMD) manufacturer, today announces the first patient enrolled in the pilot phase of the COMPANIONclinical study of a digital cognitive behavioral therapy for patients with IPF.
- The DTx, AlmeeTM, under clinical study was built on Alex Therapeutics proprietary “Alex DTx Platform”
- First clinical study with a digital therapy in patients with IPF to address the psychological symptom burden in this disease
- First patient enrolled in US pilot phase leading up to US pivotal phase of the study
- The DTx is developed by Alex Therapeutics in collaboration with Vicore Pharma. Vicore is responsible for the clinical validation and commercialisation of the DTx
The Pilot study was a 4-week, single-arm, decentralized, open-label clinical investigation in 10 patients with self-reported anxiety related to idiopathic pulmonary fibrosis (IPF). The primary objective of the study was to test the functionality, user experience, and safety of the DTx, which were all found to be positive.
Additionally, the trial provided encouraging early indications of efficacy. The patient-reported Generalized Anxiety Disorder (GAD-7*) results showed an average score reduction of 4.2. A reduction in the GAD-7 score of ≥2 points is regarded as clinically meaningful. These results, together with the safety, functionality, and user experience indications suggest that the DTx could serve as a reliable resource for addressing the psychological impact of living with IPF.
“We’re very pleased with these early efficacy results for one of our anxiety Digital Therapeutics’. Even though the patient population is small it’s a positive indication heading into the next phase of the clinical trial. Digital Therapeutics have tremendous potential for treating depressive and anxiety symptoms in somatic diseases and we look forward to continuing our work in the space.” says John Drakenberg, CEO & co-founder of Alex Therapeutics.
The full DTx, AlmeeTM, to which patients in this pilot were given limited access, has been developed by Alex Therapeutics in collaboration with Vicore Pharma, an innovative clinical-stage pharmaceutical company developing innovative medicines for severe lung disorders such as idiopathic pulmonary fibrosis (IPF). Vicore Pharma will have an exclusive license to commercialize the AlmeeTM DTx, starting in the US.
"We’re pleased with these results and working with Alex; co-collaboration on a DTx is complex but it has been a successful partnership. We look forward to the pivotal phase and 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 clinical study will be initiated during Q4 of 2022. The full DTx, AlmeeTM, will then undergo a US-based 9-week, randomized, controlled, parallel-group decentralized clinical investigation that will include 250 patients with all forms of pulmonary fibrosis (PF).