Hanmi Pharmaceutical's Rare Disease New Drug Featured as Cover Paper in SCI International Journal

Treatment for Congenital Hyperinsulinemia
Innovative New Drug 'LAPS Glucagon Analog'
World's First Weekly Injection
Proven Sustained Fasting Blood Glucose Increase
Excellent Safety and Tolerability

[Asia Economy Reporter Lee Gwan-joo] Hanmi Pharmaceutical's clinical research results for an innovative new drug treating rare diseases have been selected as the cover paper of an SCI international academic journal.

Hanmi Pharmaceutical announced on the 18th that the clinical results of 'LAPS Glucagon Analog (HM15136, Lapseu Geullukagon Analogue),' an innovative new drug being developed for congenital hyperinsulinism treatment, were published in the March 2022 issue of the SCI international academic journal Diabetes, Obesity and Metabolism (DOM).

Furthermore, considering the potential and innovativeness of LAPS Glucagon Analog, DOM selected the research as the cover paper and featured a visualized image of the molecular structure on the journal cover.

LAPS Glucagon Analog is the world's first long-acting glucagon derivative being developed with the goal of once-weekly administration. Based on its efficacy in dramatically improving the short half-life of glucagon, which promotes glucose synthesis in the body, it is being developed as a treatment for rare hypoglycemic diseases such as congenital hyperinsulinism.

The published paper evaluated safety, tolerability, and pharmacokinetics of five different doses in 56 healthy subjects, confirming excellent effects of single-dose subcutaneous injection therapy along with safety.

According to the study, LAPS Glucagon Analog significantly increased fasting blood glucose levels for up to 17 days. The company explained that this sustained blood glucose elevation shows potential to extend the dosing interval beyond the world's first once-weekly administration to even biweekly dosing.

Additionally, no serious adverse effects occurred at any dose, confirming excellent safety and tolerability, and it also demonstrated a favorable cardiovascular safety profile. Hanmi Pharmaceutical is conducting additional Phase 2 clinical trials to verify the potential benefits of LAPS Glucagon Analog in patients with rare hypoglycemic diseases.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) designated LAPS Glucagon Analog as an orphan drug for congenital hyperinsulinism in 2018. In 2020, EMA designated it as an orphan drug for insulin autoimmune syndrome, and the FDA also designated it as a Rare Pediatric Disease (RPD). The Korean Ministry of Food and Drug Safety designated it as an orphan drug in the development stage in 2019.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, “Congenital hyperinsulinism, a rare disease occurring in about 1 in 50,000 people, can be life-threatening in severe cases, but there is currently no approved treatment. As the world is paying attention to the innovativeness of LAPS Glucagon Analog, we will do our best to commercialize it quickly to dramatically improve the quality of life of suffering patients.”

This content was produced with the assistance of AI translation services.