Hanmi "Phase 3 trial confirms efficacy of GLP-1 drug"

"50% of the study participants had weight loss greater than 10%, Hanmi plans to apply for approval within this year"

Efpeglenatide is a GLP-1 drug using Hanmi Pharmaceutical

Hanmi Pharmaceutical announced on October 27 that its glucagon-like peptide-1 (GLP-1) obesity treatment candidate, 'HM11260C' (efpeglenatide), met primary endpoints in a Phase 3 top-line study in Korea.

 

The results confirmed significant weight-loss efficacy and safety compared with placebo.

 

This Phase 3 trial involved 448 non-diabetic adult patients with obesity.

 

The study aimed to evaluate the superiority of efpeglenatide over placebo in terms of the mean percentage change in body weight and the percentage of subjects achieving 5% weight loss at 40 weeks.

 

According to Hanmi Pharmaceutical, the 40-week analysis showed a statistically significant difference against placebo.

 

The proportion of subjects achieving 5% weight loss was 79.42% in the efpeglenatide group versus 14.49% in the placebo group.

 

The mean percent weight change was -9.75% in the efpeglenatide group versus -0.95% in the placebo group, confirming a least-squares mean difference of -8.13% between the groups.

 

In terms of safety, gastrointestinal adverse events were reported but generally manageable: nausea 16.72% (5.37% with placebo), vomiting 11.71% (2.01% with placebo), and diarrhea 17.73% (4.70% with placebo).

 

Hanmi Pharmaceutical plans to apply for marketing authorization with the Ministry of Food and Drug Safety (MFDS) for efpeglenatide within this year.

 

The company explained, "Although the clinical trial involves dosing and observation up to 64 weeks, we are disclosing the 40-week interim top-line data with a plan for a submission within the year," and added, "We expect to derive improved indicators from continued dosing beyond the data announced now." Efpeglenatide is a GLP-1 drug using Hanmi Pharmaceutical's long-acting platform, 'LAPSCOVERY,' and is the most advanced clinical-stage candidate in the company's obesity and metabolic disease pipeline.

 

It is also the fastest-developing obesity treatment among domestic Korean companies.

 

Hanmi Pharmaceutical initially out-licensed efpeglenatide to Sanofi for diabetes in 2015 for up to €3.9 billion (approximately KRW 5.597 trillion).

 

However, Sanofi returned the rights to the pipeline in June 2020, citing a change in business strategy.

 

In 2023, Hanmi Pharmaceutical officially announced its decision to develop efpeglenatide, initially developed for diabetes, as an obesity treatment, mirroring the strategies of Novo Nordisk and Eli Lilly in repurposing their diabetes drugs.

 

The core of Hanmi's strategy is the creation of a 'Korean GLP-1 Obesity Drug'.

 

The company intends to develop efpeglenatide as a GLP-1 obesity treatment tailored to the characteristics of the Korean obese population, which has a lower proportion of severely obese patients.

 

In a global market where Novo Nordisk and Eli Lilly have established overwhelming dominance, Hanmi Pharmaceutical aims to differentiate through price competitiveness and a stable supply chain.

 

Kim Na-young, Executive Director of Hanmi Pharmaceutical's New Product Development Division, who led the study, stated, "Efpeglenatide, a drug the late founder of Hanmi Group, Lim Sung-ki, was passionate about, has taken a big step toward commercialization as a 'national obesity drug' by yielding effective and safe clinical results in a Korean population study," and concluded, "Efpeglenatide will become a new drug demonstrating diverse potential in the metabolic disease sector, spanning from obesity to diabetes."