Allurion Technologies is advancing its swallowable gastric balloon as a viable option for weight loss, particularly for individuals who have not responded well to GLP-1 receptor agonists. Recent data highlights the efficacy and safety of the device, alongside progress in securing FDA approval, though the company faces financial challenges amidst competition from established obesity drugs.
Efficacy in Obesity Treatment
A single-center retrospective study involving 167 patients in Ecuador, with an average body mass index (BMI) of 31.3, demonstrated significant weight reduction using Allurion's intragastric balloon. Published in Clinical Obesity, the study revealed that participants achieved an average weight reduction of 15.7% after four months of therapy. The balloon works by creating a feeling of fullness, aiding in reduced food intake. Patients continued to lose weight even after the balloon had passed, with an average weight loss of around 17% at six months. Notably, 92 patients achieved more than 50% excess body weight loss by month four, increasing to 104 patients by month six. However, researchers noted a decrease in average weight loss to 14.7% after a year, indicating the need for further research on long-term weight management post-balloon expulsion.
Potential for GLP-1 Non-Responders
Allurion presented data at Obesity Week 2024 showcasing the balloon's effectiveness in patients who did not respond to Novo Nordisk's Saxenda (liraglutide). The study enrolled 27 patients who experienced either no weight loss or less than 5% weight loss with Saxenda. These patients achieved an average weight loss of 17.6% after four months of treatment with the Allurion gastric balloon. Dr. Ram Chuttani, Allurion's founding partner and chief medical officer, emphasized that a significant proportion of patients do not achieve substantial weight loss with GLP-1 medications, suggesting the Allurion Program could be a "game-changer" for these individuals.
FDA Approval Process and Clinical Trials
Allurion has initiated the FDA premarket approval (PMA) process for its weight loss balloon, submitting three modules and expecting to file the final module, containing clinical data from the AUDACITY trial, early next year. The AUDACITY trial, a randomized, pivotal, controlled study, involves 550 patients across 17 U.S. sites and is expected to conclude by the end of 2024. This trial is crucial for securing FDA approval and expanding the availability of Allurion's device in the United States.
Real-World Data and Device Mechanism
Data from a real-world study involving 19,428 patients over six years (2018-2023), tracked via Allurion’s Virtual Care Suite, showed an average weight loss of 12.2% at four months. Allurion's gastric balloon is designed for ease of use, swallowed as a capsule and filled with liquid, mimicking a full stomach without requiring surgery, endoscopy, or anesthesia. The balloon self-empties after approximately four months and passes naturally out of the body.
Financial Context and Market Competition
Despite the promising clinical data, Allurion faces financial headwinds and strong competition from GLP-1 weight loss drugs like Wegovy (semaglutide) and Mounjaro (tirzepatide). The company received a delisting warning from the NYSE and reported a significant decrease in revenue for Q4 2023. CEO Shantanu Gaur acknowledged the impact of macroeconomic conditions and the surge in popularity of GLP-1 drugs on the company's performance. Allurion is also focusing on specific patient populations, such as adolescents, for whom weight loss drugs are not yet widely approved.
