US-based biotech Fractyl Health has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a clinical trial of its Revita endoscopy system, the same day it announced a $19.2m net loss in the company’s most recent quarter.
Revita is an outpatient endoscopic technique focused on the duodenum, the first part of the small intestine. It is designed to address the underlying issues in the duodenal lining that contribute to obesity and type 2 diabetes (T2D).
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The system obtained CE approval in Europe and was granted reimbursement authorisation for T2D treatment via NUB in Germany in 2022.
The Remain-1 study will assess Revita’s efficacy in maintaining weight loss following the discontinuation of its GLP-1 receptor agonist (GLP-1RA) drug therapy. It will enrol patients on tirzepatide who have lost at least 15% of their total body weight.
Tirzepatide, marketed by Eli Lilly as Mounjaro for T2D and Zepbound for the treatment of obesity, is a GLP-1RA therapy.
The randomised, double-blind trial aims to prove Revita’s superiority over a sham treatment in terms of the percentage change in body weight from baseline to week 24. Additionally, it aims to demonstrate that a majority of patients treated with Revita maintain clinically significant weight loss after stopping tirzepatide.
In the announcement accompanying the IDE approval, Brigham and Women’s Hospital endoscopy director Christopher Thompson said: “The unmet need in obesity is shifting from ‘How do we help people lose weight?’ to ‘How do we help people keep the weight off?’”
Despite receiving IDE approval, Fractyl also delivered disappointing news on 1 April. In its fourth quarter and full-year 2023 earnings report, the company reported a $19.2m net loss for the quarter. This is an increase from a net loss of $10.9m from the same quarter in 2022.
The biotech remains positive following the announcement.
“2024 is shaping up to be a transformational year as we approach several key milestones across both our Rejuva and Revita platforms,” said Fractyl’s CEO Harith Rajagopalan.
