Daewon Pharmaceutical has taken the first step toward conducting clinical trials to develop a semaglutide-based obesity treatment as a patch.

Daewon Pharm and Raphas said Tuesday they had completed the investigational new drug application for a phase 1 clinical trial of DW-1022, a microneedle patch obesity treatment candidate jointly developed by the two companies.

Daewon and Raphas have been researching to develop Novo Nordisk's Wegoby (semaglutide) injection into a microneedle patch.

The joint development was selected as a key technology development project for the bio-industry by the Ministry of Trade, Industry, and Energy in 2020. The two companies also completed the registration of a joint patent for a microneedle patch with synthetic semaglutide last month.

Daewon has been developing raw materials equivalent to new drugs by converting genetically recombinant semaglutide into synthetic peptides and conducting nonclinical studies of finished drugs. Raphas has been developing formulations of finished drugs for microneedle patches. Based on the research, Daewon will lead the phase 1 trial.

Semaglutide was developed to increase insulin secretion in diabetic patients and approved by the U.S. Food and Drug Administration as a treatment for diabetes in 2017 and as a treatment for obesity in 2021.

However, existing self-injectable drugs have the disadvantage of causing pain and secondary infections, resulting in high patient burden and medical waste.

Daewon expects DW-1022 to be a patch that can be easily applied, eliminating the hassle of direct injection for patients. Utilizing fine needles of 1mm or less is also expected to have an excellent delivery rate in the body and fewer skin side effects.

“For chronic diseases that must be managed for a long time, such as diabetes and obesity, the convenience of taking medication is an important factor,” a Daewon official said. “We expect this to be an innovative treatment that will greatly increase absorption and convenience compared to existing injections.”