Last Updated on: 29th October 2024, 03:06 am
Oxford Medical Products is excited to announce successful topline outcomes from the initial randomised controlled trial (RCT) of Sirona, a novel, non-invasive, non-pharmaceutical technology designed to aid weight loss.
In a 12-week RCT, Sirona exhibited a good safety profile, was well-tolerated, and demonstrated clear efficacy, with participants in the Sirona group achieving greater weight loss than those on placebo. The maximum total body weight loss (TBWL) observed in the treatment arm was 10%, and 25% of participants in the treatment group lost over 5% of their total body weight (TBW).
Sirona is an inert dual-polymer hydrogel capsule that expands in the stomach, taking up space to curb appetite through mechanical suppression. Once in place, it remains in the stomach for several days, allowing for continuous appetite control. This non-invasive, well-tolerated method offers a cost-effective alternative to current weight-loss treatments.
Overweight and obesity affect more than 2 billion people worldwide, with the NHS incurring costs of £18 billion annually. Analysts from JP Morgan predict the obesity treatment market will reach $100 billion by 2030, spurred largely by GLP-1 pharmacotherapies. OMP believes Sirona’s unique qualities allow it to complement GLP-1 therapies while serving markets these medications may not. Sirona’s tolerability makes it a prime candidate for both the overweight and weight maintenance markets, helping patients transitioning off GLP-1s to maintain a healthy weight and avoid regaining lost weight.
This double-blind RCT (ISRCTN14083641) was structured to evaluate Sirona’s safety, feasibility, and tolerability. Approximately forty adults with a BMI of 30-41 were split into two groups, with participants receiving Sirona or a placebo in a 3:1 ratio. Weight loss, an exploratory endpoint, was tracked over the 12-week period. No serious adverse events (SAEs) were recorded, with most adverse events rated as mild. No participants left the study due to product-related adverse events, reinforcing Sirona’s strong safety profile. Weight loss of up to 10% was observed in the Sirona group.
Interestingly, results suggested that those with class I obesity (BMI 30-34.9) experienced greater TBW loss than individuals with class II obesity (BMI ≥35), warranting further study, as it contrasts with data on GLP-1 receptor agonists, which tend to be more effective in individuals with higher BMIs.
Dr Camilla Easter, CEO of Oxford Medical Products, commented: “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.”
She continued, “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.”
Based on these results, Oxford Medical Products plans to initiate the pivotal trial of Sirona in Q2 2025. OMP is also advancing Sirona’s potential as a gastroretentive drug delivery system, focusing initially on oral anti-obesity and metabolic drugs to improve pharmacokinetics and bioavailability.
Oxford Medical Products collaborated with the NIHR Southampton Biomedical Research Centre (Southampton BRC) and the NIHR Bristol Biomedical Research Centre (Bristol BRC) for the trial. These centres specialise in early-stage research to bridge the gap between basic scientific discovery and larger-scale studies.
The study also received support from the NIHR Southampton Clinical Research Facility.
Professor James Byrne, Chief Investigator at the NIHR Southampton BRC, said: “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 details or to discuss this development with Oxford Medical Products’ CEO, Camilla Easter.