Oxford Medical Products (OMP) has announced the additional three-month clinical trial results for Sirona, a weight-loss treatment targeting people who are overweight or have class I obesity (BMI 25-35) and those transitioning off of GLP-1 medications. The clinical trial, which took place across three NHS hospitals in the UK, showed participants taking Sirona continued to experience sustained weight loss at the three-month mark. People with class I obesity (BMI 30-35) on average lost more than 6.3% total body weight whilst on Sirona, without any ongoing diet and exercise support.
Further analysis of the 12-week data showed that participants on Sirona, consumed on average 400 fewer calories per day than those on placebo. These early data suggest that Sirona could achieve an average of 10-12% total body weight loss at 52 weeks.
Sirona is a dual-polymer hydrogel pill that, once swallowed, expands rapidly in the stomach to suppress appetite by reducing the available volume for food. Importantly, there were no serious adverse events reported in the trial, Sirona was well tolerated (95 percent of patients adhered to the dosing regimen at 12 weeks) and demonstrated a fantastic safety and side effect profile.
“OMP is at a pivotal moment, with our promising early clinical data showcasing Sirona’s potential as a safe and effective weight loss treatment,” said Dr Camilla Easter, CEO of OMP. “Our approach is highly differentiated and complementary to existing and emerging GLP-1 therapies, offering a unique, tailored solution - particularly for individuals in the overweight category. Sirona provides an optimal risk-benefit profile, enabling safe and cost-effective weight loss. In the coming years, we will advance two pivotal trials focused on both weight loss and long-term weight maintenance.”
The majority of the US and UK population is not living with obesity but are overweight, with 43% of global adults falling into the overweight category (BMI 25-30). In 2017, 39% of deaths related to high BMI occurred in people who were not living with obesity (BMI <30). However, the vast majority of these individuals do not have access to the new weight loss drugs (GLP-1s). Wegovy and Zepbound indicate use in individuals with a BMI 30-40 or 27 with at least one weight-related comorbidity, whereas Sirona is targeted at patients with a BMI 25-40.
“Sirona represents a new generation in weight-loss therapeutics, specifically for obese patients and their resulting comorbidities. In contrast to traditional weight-loss measures, Sirona's hydrogel system offers a method that is non-systemic and potentially lifelong,” added Dr Asif Humayun, an endocrinologist with the NHS. “The early results of the trial in the initial stages have been promising, particularly with how it works with the natural processes of the body to regulate weight without merely pharmacologic drugs. It can be a game-changer for patients who considered other options insufficient or unsustainable in the long term.”
Studies have some approximately 65% of the weight lost whilst on GLP-1 treatments is regained within 12 months of stopping. With 30 million people expected to be using GLP-1s in the US alone by 2030, there is an urgent need for a safe, cost-effective and well-tolerated weight maintenance solution. The company sees Sirona as that solution - uniquely positioned to assist individuals transitioning off GLP-1s, helping to prevent weight regain and to maintain their new weight long term
Ruth, a patient who participated in the Sirona trial, explained her experience with Sirona: “During the trial, my BMI went from 37.7 to 31.2. Sirona tablets turned me into what I have seen in other people, who tend to be a healthy weight. People who are in control and don’t have the desire to eat or can control what they are eating. This was a lightbulb moment, this hydrogel had almost turned a control switch on for me without introducing any chemical-altering substances. I feel Sirona is an absolute game changer for weight management and the solution to a big issue for me.”
The OMP team sees Sirona as a highly complementary solution to GLP-1s. Sirona is uniquely designed to support individuals both before and after GLP-1 eligibility. Obesity is a highly complex and heterogeneous chronic disease, now affecting over 2.5 billion people worldwide. Addressing this global health challenge requires multiple weight loss solutions tailored to the diverse needs of patients at every stage of their weight loss and maintenance journey.
OMP is set to advance Sirona into a larger pivotal trial in both the US and UK later this year, continuing their mission to hand millions the power to achieve a healthy weight. OMP is led by a team of scientists, medical professionals and entrepreneurs who have come together to solve one of the world’s toughest and most urgent medical challenges. To date, they have raised US$13 million to develop a safe and affordable weight loss treatment. The company was founded in 2017 and is based in Oxford, UK.
Comments