Huons Gains IND Approval to initiate Phase 1 Clinical Trial of Anti-obesity Treatment ‘HUC2-676’ in Korea

- Low-Molecular-Weight Synthetic Peptides based on Saxenda -

Huons has launched a strategic initiative to enter the anti-obesity treatment market by developing synthetic peptides of glucagon-like peptide-1 (GLP-1).

Huons Co., Ltd. (CEO Soo-young Song) announced on the 17th that it received Investigational New Drug (IND) approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial of ‘HUC2-676’.

HUC2-676 is a low-molecular-weight synthetic peptide developed based on Novo Nordisk’s biopharmaceutical, Saxenda injection (liraglutide). The newly approved clinical trial is designed to evaluate pharmacokinetic (PK) equivalence between HUC2-676 and Saxenda following administration to healthy adult subjects.

Over the past two years, Huons has been pursuing the development of an anti-obesity treatment based on a GLP-1 receptor agonist (GLP-1RA) as a key strategic project to secure future growth drivers.

Huons operates an end-to end manufacturing line for cartridge-type topical anesthetics (lidocaine). This cartridge-based manufacturing technology and equipment - also recently used for injectable obesity therapies such as Saxenda and Wegovy - positions the company a competitive advantage in developing synthetic GLP-1RA peptides.

GLP-1RA-based anti-obesity treatments have recently emerged as a major trend, driven by growing public interest in healthy lifestyle and weight management. In particular, the expansion of indications for liraglutide, originally developed for diabetes, to include anti-obesity has significantly transformed the anti-obesity treatment market.

GLP-1RAs are known to promote insulin secretion and suppress the secretion of glucagon (which raises blood glucose), and to induce satiety by acting on the hypothalamus in the brain.

“We plan to obtain Marketing Authorization(MA) by establishing quality equivalence between HUC2-676 and Saxenda, supported by non-clinical data and Phase 1 clinical trial results,” said Kyung-mi Park, Vice President and Head of R&D at Huons. ”By developing a low-molecular-weight synthetic peptide that demonstrates equivalence to existing biopharmaceuticals, we aim to provide a new therapeutic option for obesity”, she added.

In addition to the HUC2-676, Huons is pursuing ongoing research and development efforts to expand its anti-obesity pipeline.

Huons is also participating in a government-funded R&D project to develop an oral table formulation of semaglutide. In September last year, the company was selected for the `2024 Material Parts Technology Development Project (Packaged Type)` organized by the Ministry of Trade, Industry and Resources to develop oral peptide drugs. The project spans five years (3 years for Phase 1 and 2 years for Phase 2) with a total budget of KRW 8.13 billion, including KRW 6.3 billion funded by the government.

Huons is leading the development for oral peptide drug product manufacturing technologies based on novel materials. Together with Chung-Ang University, Kookmin University, and Sungkyunkwan University as partner research institutes, the company is developing absorption enhancers to improve bioavailability, securing formulation technologies, and developing manufacturing process technologies.

Meanwhile, Huons plans to strengthen its competitiveness in the obesity market by expanding it obesity drug portfolio, including appetite suppressants such as Hutermin Tab. And Fendy Tab.