Amid the hype of weight loss pills, Allurion is pushing ahead with its swallowable balloon – with the company reporting the device leads to a 13.1% reduction in weight.
The data from a study published in the Obesity Surgery journal evaluated the balloon in adolescent patients living with obesity who had not responded to previous dietary and behavioural modification weight loss treatments.
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Across 91 patients involved in the trial in Italy, Spain, and Chile, Allurion’s device led to a 13.1% mean total body weight loss. Out of the cohort, 80 reported no adverse events, with the remaining 11 experiencing either nausea or vomiting, abdominal pain, or flatulence. Allurion intragastric ballon demonstrated a good safety profile, with no reported serious adverse events or premature device removals.
Allurion’s gastric balloon has been available in Europe since it received CE marking in 2015. The company completed enrollment in a US pivotal trial called AUDACITY to support future US Food and Drug Administration (FDA) approval.
Alluroin’s balloon is swallowed as a capsule and then filled with liquid. From here, it acts similar to a traditional gastric balloon that promotes weight loss by mimicking a full stomach. Unlike other approaches, Allurion’s balloon does not require surgery, endoscopy, or anaesthesia. After around four months, the balloon releases the liquid on its own and it passes out of the body naturally.
Allurion highlights the study’s importance by pointing towards the lack of effective device treatments in adolescents for obesity.
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By GlobalDataThe popular weight loss drug Wegovy (semaglutide) developed by Novo Nordisk is approved for those aged 12 years and older while Eli Lilly’s Zepbound (tirzepatide) is still only available for adults aged 18 years and older.
Wegovy’s use in adolescents has skyrocketed, as per data shared with Reuters. However, the United States Preventive Services Task Force concluded that the evidence for the use of pharmacotherapy, including GLP-1 agonist drugs such as Wegovy, was inadequate in children and adolescents.
Allurion’s chief medical officer Dr Ram Chuttani said: “Bariatric surgery and long-term pharmacotherapy, although effective in adults, raises concerns about invasiveness and potential risks when applied to adolescents.
“We believe that the results of this study mark a significant milestone in the treatment of adolescent obesity, as the Allurion Balloon offers a non-invasive treatment option without several of the issues related to surgery and medications.”
The company went public on the New York Stock Exchange (NYSE) via a deal with special-purpose acquisition company (SPAC) Compute Health last year, valuing the combined company at around $500m at the time. Sales for the balloon have decreased, however, as GLP-1 agonist drugs took a stranglehold on the weight loss market, with Allurion reporting an $11m drop in revenue in Q4 2023 compared to the same period in 2022.
Last month, Allurion received a notice from the NYSE about listing standards due to its average stock price falling below the required level, meaning the company could be delisted from the exchange in the future.
