Curebase selected to launch a clinical investigation of a digital therapeutic for IPF
US pilot phase leads to US pivotal study scheduled for Q3 2022
SAN FRANCISCO, April 21, 2022 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, today announced the initiation of the pilot phase of COMPANION, the first clinical investigation of a new digital therapeutic (DTx) for patients with IPF, a rare lung disease. The DTx is owned by Vicore Pharma, a clinical-stage pharmaceutical company.
The COMPANION study is a randomized, controlled, parallel-group clinical investigation evaluating the impact of Vicore's digital cognitive behavioural therapy on psychological symptom burden, specifically anxiety and depressive symptoms, in adults diagnosed with idiopathic pulmonary fibrosis (dCBT IPF). Patients with IPF have a life expectancy of 3 to 5 years, during which dyspnea, fatigue, and cough symptoms usually worsen.
Curebase's DCT platform and services will help Vicore recruit patients for this clinical study offering the potential to expand patient recruitment to more diverse and non-mobile patient populations. The COMPANION study will take place in the US and is designed to minimize the burden on IPF patients, conducted using Curebase's decentralized and virtual clinical research solutions. Curebase has extensive experience in the DTx space and is the premier thought leader for the Digital Therapeutics Alliance (DTA) in building resources to effectively execute DTx clinical research. Their decentralized clinical trial model ensures more diverse and far-reaching studies because unique populations – which typically are underrepresented in clinical trials – can be included. This strength is especially important for engaging with rare disease populations because these small patient groups are often spread widely around the globe. The company's virtual research sites and engagement with community sites and networks also provide physicians with new and unique options to offer their patients, regardless of location, which is ideal for the emerging DTx research space. The Curebase platform empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
"The Vicore DTx is specifically developed to address the psychological impacts of IPF and the aim of this investigation is to refine the interactive nature of the therapy sessions to ensure that the patients see a real reduction in symptoms from a clinically validated treatment," said Jessica Shull, director of Digital Therapeutics at Vicore. "This decentralized clinical investigation also gives us an opportunity to rethink the traditional clinical trial model while keeping the patient in focus."
"Curebase is excited to work with Vicore to research the viability of their new DTx for IPF," said Tom Lemberg, founder and CEO of Curebase. "We built our solutions with innovation and emerging therapies at the heart of our mission. Patients around the world want to have easier access to cutting edge medicine to find possible solutions for their ailments and Curebase was built with them in mind. The research we are supporting with Vicore is just another example of our efforts to further democratize the world's clinical research."
The Vicore DTx is subject to medical device regulation in the US and Europe and is developed in partnership with Sweden-based, Alex Therapeutics. Alex Therapeutics develops software as a medical device (SaMD) digital therapeutics using cognitive behavioral therapy (CBT) and artificial intelligence (AI).
Results from the COMPANION pilot study are expected in Q2 2022. Key results from the pivotal phase are expected 2023.
About Vicore Pharma AB
Vicore is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe diseases where the Angiotensin II type 2 receptor (AT2R) plays an important role. The company currently has four development programs, VP01, VP02, VP03 and VP04. VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF) and COVID-19. VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. VP03 includes the development of new AT2 receptor agonists. VP04 develops a clinically validated digital therapeutic (DTx) – a digital cognitive behavioral therapy specifically developed to treat anxiety and depression in adults with IPF.
The company's shares (VICO) are listed on Nasdaq Stockholm's main market. For more information, see www.vicorepharma.com.
About Alex Therapeutics
Alex Therapeutics is a medtech company based in Stockholm which designs and develops Software-as-a-Medical-Devices (SaMDs). With the proven "Alex DTx Platform", expertise in artificial intelligence and evidence-based psychology, Alex Therapeutics is uniquely positioned to deliver cutting-edge and reliable DTx products that demonstrably improve the health of their patients. The company has served tens of thousands of patients, has experience with clinical validation, and positive patient testimonials. For more information, visit www.alextherapeutics.com and follow us on LinkedIn.
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human wellbeing through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they livAe. By applying cutting edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.
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