Oxford Medical Products Debuts Promising Results from First Randomised Controlled Trial (RCT) of Sirona: A Revolutionary Non-Pharmacological Weight-Loss Treatment

In a 12-week randomised controlled trial (RCT), Sirona demonstrated a good side effect profile and was well tolerated by trial participants. A clear treatment effect was seen, with participants on Sirona experiencing greater weight loss compared to those receiving a placebo. The highest percentage total body weight loss (TBWL) seen in the treatment arm was 10%, with 25% of people on treatment losing >5% total body weight (TBW). 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.