Stockholm, 5th December 2022 — Alex Therapeutics and Vicore Pharma today announce the first study subject enrolled in the pivotal study COMPANION evaluating Almee™, a digital cognitive behavioral therapy for anxiety in patients with PF. The study, named COMPANION, will enroll 250 patients in the United States with PF in a 9-week program.
- Randomized clinical investigation to evaluate the impact of Almee™ in adult subjects with PF
- The Digital Therapeutic (DTx) was developed by DTx leader Alex Therapeutics using the proprietary “Alex DTx Platform” in partnership with Vicore Pharma
- Two hundred fifty patients will enroll in the US decentralized clinical study
Pulmonary Fibrosis (PF) is a group of serious lung diseases that affect the respiratory system, occurring when lung tissue becomes damaged and scarred. In a preceding study, it was shown that 63% of PF patients report treatable levels of anxiety. The Almee™ DTx utilizes Cognitive Behavioural Therapy (CBT) to provide evidence-based support alleviating the high psychological burden caused by PF.
“We’re very excited to see our second Digital Therapeutic enter into a large-scale clinical trial in the US. This is a major step in helping to alleviate the psychological burden of PF patients and we look forward continuing to bring innovative Digital Therapeutics to market.” Says Oliver Fleetwood, CTO and co-founder of Alex Therapeutics.
The COMPANION study will examine the impact of Almee™ on anxiety in patients with PF by looking at the change from baseline in anxiety symptom severity assessed by GAD-7*. The study is a fully digitized, randomized, controlled parallel-group clinical investigation. Patients enrolled in the investigation will be randomized to Almee™ or a treatment-as-usual control group. For more information about the study, visit www.vicorecompanionstudy.com.
The DTx, Almee™, has been developed by Alex Therapeutics in collaboration with Vicore Pharma. Vicore Pharma have an exclusive license to commercialize the Almee™ DTx, starting in the US. The intention is for the dCBT-PF Almee™ to be submitted for FDA clearance as a prescription medical device treating anxiety symptoms in patients with pulmonary fibrosis.
About Almee™
Almee™ is a Digital Therapeutic (DTx) developed by Alex Therapeutics in collaboration with Vicore Pharma. DTx products are medical devices subject to national regulations requiring clinical evidence. Almee™ is a digital Cognitive Behavioural Therapy based on traditional CBT methodologies, specifically conceived and designed for the Pulmonary Fibrosis community.
About Alex Therapeutics
Alex Therapeutics is a digital therapeutics (DTx) company that partners with pharmaceutical companies to create and license digital therapies. With the proven “Alex DTx Platform”, expertise in patient-centric design, and evidence-based psychology, Alex Therapeutics is uniquely positioned to deliver safe and effective DTx Software-as-a-medical-devices (SaMDs) to the global market. The company has treated tens of thousands of patients, has clinically validated products, as well as overwhelmingly positive patient and partner testimonials. For more information, visit www.alextherapeutics.com or follow us on LinkedIn.
For further information, please contact:
Alex Therapeutics
Sebastian Blendow, COO & CFO
Upplandsgatan 7, 11123 Stockholm, Sweden
E-mail: press@alextherapeutics.com
Website: www.alextherapeutics.com
For inquiries regarding partnerships, please contact:
Gergana Almquist, Ph.D., Global Partnership Manager
E-mail: partner@alextherapeutics.com
About Vicore Pharma Holding AB (publ)
Vicore is an innovative Swedish clinical-stage pharmaceutical company dedicated to creating life-changing treatments in diseases where the Angiotensin II type 2 receptor (AT2R) is central to the disease pathology. The company currently has four development programs, VP01, VP02, VP03, and VP04. VP01 aims to develop the substance C21 for treating idiopathic pulmonary fibrosis (IPF) and pulmonary artery hypertension (PAH). VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. The VP03 program develops new AT2 receptor agonists. VP04 develops a clinically validated digital therapeutic for PF patients.
The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
Read the full Vicore Press release here
*About GAD-7
GAD-7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD). Spitzer RL, Kroenke K, Williams JB, et al.; A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.
