Hanmi Pharmaceutical Introduces World's First Monthly Injection Innovative Drug for Short Bowel Syndrome in Phase 2 Clinical Trial in Europe

Hanmi Pharmaceutical.

[Asia Economy Reporter Lee Gwan-joo] Hanmi Pharmaceutical announced on the 31st that it will present a poster on the global Phase 2 clinical trial of the innovative drug for short bowel syndrome treatment, 'LAPS GLP-2 Analog (HM15912)', developed as the world's first once-monthly formulation, at the European Society for Clinical Nutrition and Metabolism (ESPEN).

In this presentation, Hanmi Pharmaceutical will introduce detailed information on the clinical design, patient selection criteria, clinical duration, and target endpoints under the theme of "Ongoing Phase 2 Clinical Trial of a New GLP-2 Analog for Short Bowel Syndrome-Intestinal Failure (SBS-IF) Patients." Recently, Hanmi Pharmaceutical initiated global and domestic Phase 2 clinical trials of HM15912 monotherapy in patients with short bowel syndrome.

HM15912 is an innovative drug applying Hanmi Pharmaceutical's drug-sustaining platform technology, 'LAPSCOVERY', to a GLP-2 analog. Based on improved in vivo durability of GLP-2 and excellent villus cell growth-promoting effects, it is being developed as the world's first once-monthly formulation. It was designated as an orphan drug by the US FDA, European EMA, and Korea's Ministry of Food and Drug Safety in 2019. In 2020, it was designated as a Rare Pediatric Disease (RPD) by the FDA, and last year, it was designated as a Fast Track development drug.

Short bowel syndrome is a rare disease characterized by malabsorption occurring when the small intestine length is less than 200 cm in adults due to congenital or acquired causes, resulting in severe malnutrition. Patients must undergo artificial treatments such as total parenteral nutrition (a method of supplying nutrients directly into the central or peripheral veins) for more than 10 hours daily to maintain daily life, causing great suffering not only to patients but also to their families.

Additionally, long-term intravenous nutrition can lead to injection site infections, sepsis, or thrombosis. Although survival rates vary by report, the 6-year survival rate is only about 65%. Particularly, pediatric short bowel syndrome, which occurs in approximately 24.5 out of 100,000 newborns, severely affects growth and development, making innovative treatments urgently needed.

A Hanmi Pharmaceutical official stated, “Through accumulated research, we confirmed a drug half-life of over 100 hours, and based on this, we confirmed the possibility of developing a once-monthly formulation. We will do our best to develop this as an innovative treatment that can significantly improve the quality of life for patients through the ongoing preliminary and current clinical studies.”

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