Oxford, United Kingdom, 22 October, 2024 – Oxford Medical Products is pleased to announce positive topline results from the first randomised controlled trial (RCT) of Sirona, its innovative, non-invasive and non-pharmaceutical weight loss technology.
Sirona is an inert dual-polymer hydrogel pill that rapidly expands in the stomach to occupy space and mechanically suppress appetite. Once deployed in the stomach, Sirona's size allows it to remain there for several days and provide continuous appetite suppression, a crucial component in achieving effective weight loss. Sirona’s mechanical mode of action is non-invasive, safe, well tolerated, and comes at a fraction of the cost of existing treatments.
Overweight and obesity affects over 2 billion people worldwide and costs the NHS £18 billion per year. JP Morgan analysts have predicted the obesity treatment market will be worth $100 billion by 2030, driven largely by the advent of the GLP-1 pharmacotherapies. OMP views Sirona as a highly differentiated technology that complements the GLP-1 pharmacotherapies but can also access several market segments these therapies cannot. Sirona’s safety and tolerability profile makes it uniquely positioned to enter the overweight treatment market and the rapidly growing weight maintenance market, to help patients transitioning off GLP-1s avoid weight re-gain and maintain a healthy weight long-term.
The randomised double-blinded controlled trial (ISRCTN14083641) was designed to assess the safety, feasibility, and tolerability of Sirona. Approximately forty adults with a BMI between 30-41 were split into two groups, with participants receiving either Sirona or a placebo in a 3:1 ratio respectively. Weight loss was measured as an exploratory endpoint, over the 12 weeks. There were no serious adverse events (SAEs) reported over the 12 weeks, with the vast majority of reported adverse events being graded mild. No participants withdrew from the study due to product-related adverse events, highlighting Sirona’s excellent safety and tolerability profile. Participants in the Sirona treatment group lost up to 10% of their total body weight.
Interestingly, in this small trial looking at early exploratory weight loss analysis, those with class I obesity (BMI of 30-34.9) lost a greater percentage of TBW than those with class II obesity (BMI ≥35). This finding warrants further investigation, as it contrasts with existing literature on GLP-1 receptor agonists, which typically demonstrate greater efficacy in individuals with higher BMIs.
Commenting on the results, Oxford Medical Products’ CEO, Dr Camilla Easter, said: “Data like these prove our initial belief – that Sirona represents a safe approach to weight loss. We are extremely pleased that the participants in our study responded well to Sirona, and we have now delivered over 8,000 doses, with our fantastic safety profile and non-pharmacological approach we are uniquely positioned to disrupt the overweight and obesity treatment market.”
Continuing, she said: “Sirona’s effect in the BMI category 30-34.9 may also indicate its potential as an effective treatment option for people with an overweight BMI (25-30) who currently have very few treatment options available. Due to the scale and complexity of the obesity crisis, there is an urgent need for a broader range of treatment options to address the needs of individuals living with excess weight and obesity. Sirona offers a totally novel solution, which can be used stand alone or in conjunction with other medical weight loss treatments. Oxford Medical Products are both proud and excited to offer an alternative and complimentary solution for people living with overweight and obesity.
Off the back of these results, Oxford Medical Products now plans to commence the pivotal trial of Sirona in Q2 2025. OMP is also advancing the technology as a gastroretentive drug delivery system, in addition to a standalone obesity treatment. The initial focus will be on delivering oral anti-obesity and other metabolic drugs, with the goal of enhancing their pharmacokinetic profiles and, ultimately, improving their oral bioavailability.
Oxford Medical Products partnered with the National Institute for Health and Care Research (NIHR) Southampton Biomedical Research Centre (Southampton BRC) and the NIHR Bristol Biomedical Research Centre (Bristol BRC) for the clinical trial. BRCs focus on early phase translational research and experimental medicine to bridge the gap between early discovery science and studies involving large numbers of people.
This study also received support from the NIHR Southampton Clinical Research Facility.
Professor James Byrne, Chief Investigator of the study from the NIHR Southampton BRC, added: “This first-in-human study of Sirona is a really exciting collaboration between the team at the NIHR Southampton BRC and Oxford Medical Products. Working with clinical research colleagues at the Bristol BRC and Milton Keynes, we have delivered a randomised study confirming safety, feasibility and tolerability of this completely new and first in class product as a tool to support those living with overweight and obesity. I am delighted that our results clearly also demonstrate the potential of Sirona as an entirely new approach to weight loss and weight management. Our team is looking forward now to the pivotal study planned for 2025 as the next step that will further assess the effectiveness of Sirona in a larger multinational randomised trial.”
For more information, or to discuss the news directly with Oxford Medical Products’ CEO, Camilla Easter, please contact:
Notes To Editors
About Oxford Medical Products
Oxford Medical Products is a UK-based biotechnology start-up revolutionizing the weight-loss treatment space with its non-pharmacological technology, Sirona.
The company was founded in 2017 by Dr Nick Edwards, Professor Jan Czenurska and Dr Hutan Ashrafian, who combined their expertise in material science, bariatric surgery and enterprise. They then brought on Dr Camilla Easter to further develop the company’s assets, taking them from early design, through proof of concept, pre-clinical and into the clinic.
OMP’s lead asset is Sirona, a dual polymer hydrogel pill. When it enters the stomach, Sirona quickly swells, taking up volume and leading to appetite suppression.
OMP is now also developing the core polymer technology as a gastro-retentive drug delivery system. Initially focusing on cardiometabolic drugs, OMP’s technology is designed to improve both pharmacokinetic (PK) profiles and increase the bioavailability of orally dosed small molecules and peptides.
The company has raised £9.5M to date. This funding was used to take Oxford Medical Products through to its current clinical activities. The company is currently preparing for their pivotal trials.
About the National Institute for Health and Care Research
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
