OMP begins first human trial of self-expanding hydrogel capsule Sirona
Oxford Medical Products (OMP) has initiated the first human trial of Sirona, its self-expanding hydrogel capsule which aims to deliver a safe, effective and affordable breakthrough technology for weight loss. The trial will provide people with obesity and overweight with an alternative solution to bariatric surgeries and gastric balloons. OMP has designed Sirona so that once it is commercially available it will come at an affordable price, allowing millions of people with excess weight to access this new solution.
Taken orally at home, Sirona’s objective is to provide a feeling of fullness that can contribute to a reduction in hunger as a means to weight loss. Once in the stomach, Sirona expands rapidly, filling the stomach and providing a feeling of satiety. According to OMP, unlike other hydrogel-based weight-loss solutions, Sirona is designed to be effective 24/7 before being passed naturally. It specifically targets the stomach to achieve appetite suppression. Patients can re-dose to ensure the constant effect of Sirona.
“With more than 65 percent of the western population affected by excessive weight, there is an urgent need for a new scientific approach to weight loss,” said Dr Camilla Easter, CEO of Oxford Medical Products. “OMP aims to redefine the obesity treatment space by providing a solution that is designed to be affordable, effective, and accessible for hundreds of millions of people in need of appropriate support to ensure their weight-loss journey is successful and long lasting.”
OMP has partnered with the NIHR Southampton Biomedical Research Centre (BRC) for the clinical trial. The study will be led by Chief Trial Investigator Mr James Byrne (General Surgeon). The NIHR Southampton BRC is part of the NIHR and hosted by University Hospital Southampton NHS Foundation Trust in partnership with the University of Southampton. The BRC takes new discoveries, treatments and technologies into the clinic, with support from the NIHR Southampton Clinical Research Facility.
“I am really excited to be working with Oxford Medical Products who have developed a completely original approach to the serious problem of obesity, with Sirona, a product that has the potential to transform our approach to people living with overweight and severe obesity” said Mr James Byrne, Consultant Surgeon at University Hospital Southampton. “Our research team at the University of Southampton are working with research leaders at Bristol and Oxford universities, who will be evaluating this intervention with cutting edge technology and digitally driven data capture. I am very proud to be in the team performing this critically important research.”
As part of the study, the Oxford Centre for Clinical Magnetic Resonance Research (OCMR) at Oxford University will be carrying out the MRI scans and scan analysis of each participant. Damian Tyler, Professor of Physiological Metabolism and Oliver Rider, Associate Professor of Cardiovascular Medicine at the Oxford University Radcliffe Department of Medicine, will lead the imaging and its analysis.
The clinical trial will take place over the course of a year and has been designed to test 48 participants for three specific modules; safety, dosing and feasibility. Sirona hydrogel pills will be taken on a flexible dosing regime to sustain full satiety. Once they have passed naturally, participants will re-dose to continually have Sirona in the stomach to feel its effects.
“Combining biomedical, dietetic and experimental psychology expertise in our nutrition theme within the Bristol BRC, allows us to offer Oxford Medical Products additional insight into day-to-day variation in appetite and eating behaviour to fully explore this novel approach to sustainable weight loss,” explained Julian Hamilton-Shield, Professor of Diabetes and Metabolic Endocrinology and industry lead for Bristol’s NIHR Biomedical Research Centre.