Head-to-head large-animal data in Diabetes, Obesity and Metabolism demonstrated unprecedented efficacy for obesity and diabetes
- 8x impact on body weight vs Semaglutide (Ozempic/Wegovy)
- 2x greater improvement in insulin sensitivity
- Fully reversible, incision-free device placed endoscopically in under 30 minutes
- Addresses over 50M adults with BMI =35 and diabetes, not effectively treated by drugs or surgery
Keyron today announced publication of landmark head-to-head preclinical results against Semaglutide, the active ingredient in Ozempic and Wegovy, which generated $28 billion in 2024. Published in leading peer-reviewed journal Diabetes, Obesity and Metabolism, the data show ForePass delivered groundbreaking efficacy in large-animal models of obesity and diabetes.
In growing pigs over four weeks, ForePass limited weight gain to just 2.0 kg (4%) compared with 16.3 kg (36%) with Semaglutide and 21.1 kg (47%) with controls (p<0.0001). Semaglutide reduced weight gain by only 11% versus controls (p<0.05), mirroring outcomes observed in humans. ForePass also improved insulin sensitivity critical in diabetes with more than twice the effect of Semaglutide.
ForePass is designed for patients with severe obesity (BMI =35) and type 2 diabetes; these patients require ~30% weight loss to reverse disease. GLP-1 drugs cannot meet this need: 92% of patients on Semaglutide fail to achieve even 15% weight loss (New England Journal of Medicine, 2021; 385(6):503-515), and 85% discontinue treatment within 24 months (Reuters, 10 July 2024). With fewer than 1% of eligible patients undergoing bariatric surgery due to invasiveness and risk, more than 50 million patients in the US and EU5 remain unaddressed.
ForePass uniquely bridges this gap. Unlike current endoscopic devices that perforate, ablate, puncture, or suture tissue, ForePass is placed and removed endoscopically in under 30 minutes, leaving the stomach and intestines completely intact. Safety and tolerability have been demonstrated across multiple studies, while efficacy approaches surgical levels without incisions.
Prof. Geltrude Mingrone MD, Principal Investigator (Professor of Medicine at King's College London and member of The Lancet Commissions for Obesity and Type 2 Diabetes, which set US, EU, and international clinical guidelines), said:
"This is a defining moment for the field. ForePass achieves the metabolic benefits of surgery without the risks, invasiveness, or anatomical alteration. For the more than 50 million patients in the US and EU5 with severe obesity and diabetes, this is a unique and urgently needed solution that medicine has never been able to offer until now."
David Feigal MD, former Director of the FDA's Center for Devices and Radiological Health and Keyron's Head of Regulatory Affairs, said:
"These are exactly the kind of results that get regulators' attention. ForePass delivers truly transformative efficacy with an incision-free safety profile that supports rapid clinical translation. This is the breakthrough the field has been waiting for in my opinion, the single most important innovation in the treatment of severe obesity and diabetes."
Dr Giorgio Castagneto Gissey, CEO of Keyron, said:
"This data is unambiguous. GLP-1 drugs fail 92% of the time to deliver meaningful weight loss. For the first time, more than 50 million patients have a powerful option to reverse disease without surgical removal of the stomach or small intestine. ForePass is the unique solution positioned to redefine the field and set a new standard of care."
About Keyron
Keyron is pioneering non-surgical biometabolic therapies that replicate the effects of bariatric and metabolic surgery without incisions. Unlike drugs that cannot deliver the efficacy patients need and that create life-long dependency, ForePass offers a scalable alternative to surgery for severe obesity and diabetes. Headquartered in London with operations on the U.S. East Coast, Keyron is redefining treatment options for more than 50 million underserved patients worldwide.
View source version on businesswire.com: https://www.businesswire.com/news/home/20251001092529/en/
Contacts:
Media Contact
Keyron Press Office
press@keyron.com
London (UK) and Boston (MA, USA)
Investment Contact
Giorgio Castagneto Gissey, CEO, Keyron
gcgissey@keyron.com
