Oxford Medical Products touts positive safety data for ‘mechanical’ weight loss pill - Clinical Trials Arena

Oct 23, 2024

The company is eyeing a pivotal trial for its dual-polymer hydrogel stomach implant following promising first-in-human trial data.

The surge of popularity of weight loss drugs has created a rivalry with traditional device orientated approaches, but a new technology aims to tread a fine line in between.

Oxford Medical Products has developed a pill that works not by pharmacological activity, but by mechanical intervention. The UK-based company calls its product Sirona – and the device has just produced positive data in a first-in-human clinical study.

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The pill, made of inert dual-polymer hydrogel, works by expanding once in the stomach to occupy space and mechanically suppress appetite via distension on the stomach wall. The device remains in the stomach for several days and provides a continuous reduction in appetite.

The randomised controlled trial, designed to assess the safety, feasibility, and tolerability of Sirona, enrolled around 40 adults with a body mass index (BMI) between 30-41. Participants received either Sirona or a placebo and followed for 12 weeks. Oxford’s device led to no serious adverse events, with no participants withdrawing from the study due to product-related adverse events. Participants in the Sirona treatment group lost up to 10% of their total body weight, though the company did not reveal if this was statistically significant compared to placebo.

Oxford Medical’s 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.”

The obesity treatment market has been taken over by GLP-1 agonist drugs, such as Novo Nordisk’s Wegovy (semaglutide) and Eli Lilly’s Zepbound (tirzepatide). Both drugs are forecast to blast past the $30bn annual revenue mark in the next decade, according to analysis by GlobalData. Their popularity has meant some medical device companies in the space have started to struggle, such as Allurion with its swallowable intragastric balloon. One area of promise, as Oxford Medical Products itself has highlighted, is the multidisciplinary management of obesity, namely a drug and device symbiosis.

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Oxford Medical Products is advancing the hydrogel pill and now plans to commence a pivotal trial of Sirona in Q2 2025. In addition to standalone obesity treatment, the company said it is also advancing the technology as a gastroretentive drug delivery system, with focus on delivering oral anti-obesity and other metabolic drugs, with the aim of improving oral bioavailability.

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