NEW YORK, Sept. 30, 2021 /PRNewswire/ -- ObvioHealth, a global Virtual Research Organization (VRO), today announces the launch of a first-of-its kind clinical trial in Australia, using a combination of in-home data collection methods that will reduce, and in some cases, eliminate the need for follow-up visits to clinics.
The randomized, double-blind, placebo-controlled trial with Anatara Lifesciences (ASX:ANR) will evaluate the safety and efficacy of a Gastrointestinal Re-Programming complementary medicine (GaRP) for participants with irritable bowel syndrome – diarrhea subtype (IBS-D).
Patients will report the severity of IBS-D symptoms and anticipated relief, quality of life, treatment adherence and changes in health status through ObvioHealth's easy-to-use smartphone application. All data from the app flows into the ObvioHealth platform, where it is monitored in real time, allowing the study team to quickly detect possible adverse events and issues with protocol adherence.
Clinical assessments will be performed during in-home visits by a study nurse to measure vitals and perform sample-collection. Patients who wish to be assessed at a clinic will have access to a research center nearest them during the treatment period.
The unique study design and use of ObvioHealth's technology for virtual data capture removes barriers to recruitment, allowing enrollment to occur anywhere in Australia, even rural areas, and diversifying the study population.
"Irritable Bowel Syndrome (IBS) impacts around one in five Australians at some point in their life with no current definitive cure," said Steve Lydeamore, Anatara's CEO. "It is anticipated that GaRP's mechanism of action will relieve symptoms of IBS-D by reducing inflammation and assisting repair of the gut lining, positively influencing the homeostasis and metabolites of the microbiome. We are pleased to be collaborating with ObvioHealth in undertaking this clinical trial to demonstrate these anticipated benefits following extensive pre-clinical work on the GaRP programme."
"Of the more than 40 virtual and hybrid studies we've conducted around the world, this is our first in Australia," said Ivan Jarry, ObvioHealth's CEO. "We're excited to partner with Anatara Lifesciences and to work with patients 'down under'. In a country with such vast rural areas, we're pleased to be able to offer clinical trial opportunities wherever patients live."
ObvioHealth is an end-to-end Virtual Research Organization (VRO) that delivers better data to sponsors and an easier clinical trial experience for participants. The company developed and launched one of the first patient-centric apps downloadable on smartphones, enabling people to participate in clinical trials from the comfort of their homes. In the 4 years since launch, the company has been awarded over 40 studies from 22 blue chip clients, implemented in 28 countries, across 17 different therapeutic areas.
About Anatara Lifesciences
Anatara Lifesciences Ltd (ASX:ANR) is developing and commercializing innovative, evidence-based products for gastrointestinal health, where there is significant unmet need. Anatara is a life sciences company with expertise in developing products for animal and human health. Anatara is focused on building a pipeline of human gastrointestinal health products. Underlying this product development program is our commitment to delivering real outcomes for patients and strong value for our shareholders.