Hanmi presents study on short bowel syndrome drug's potential as GVHD treatment in Europe

Hanmi Pharm has suggested that the company could develop HM15912, its short bowel syndrome treatment candidate developed as a once-monthly dosage form, as a treatment for another rare disease, graft-versus-host disease (GVHD).

Hanmi said Thursday that it presented two posters on the research results of HM15912 at the European Society for Clinical Nutrition and Metabolism (ESPEN Congress 2023) held in Lyon, France, from Monday to Thursday.

HM15912 (LAPSGLP-2 analog), which Hanmi is developing to treat short bowel syndrome, is an innovative new drug with proprietary platform technology LAPscovery and is being developed as the world's first once-monthly dosing formulation based on GLP-2's improved persistence in the body and its excellent villus growth-promoting effect.

LAPSGLP-2 analog was granted orphan drug designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Korean Ministry of Food and Drug Safety in 2019, pediatric orphan drug designation (RPD) by the FDA in 2020 and fast-track development designation by the FDA in 2021. A global phase 2 clinical trial is underway.

In the European meeting, Hanmi highlighted HM15912's ability to promote small intestine growth and reduce intestinal inflammation as a potential new treatment for GVHD.

GVHD occurs when lymphocytes transfused during bone marrow transplantation attack the immunocompromised patient's body, causing various complications, and has a very high mortality rate. The standard treatment is steroids or a combination of steroids and immunosuppressive drugs, but their efficacy is limited.

In this study, Hanmi demonstrated significant improvements in GVHD scores and survival with HM15912 for both prophylactic and therapeutic use in animal models of GVHD. It also found that HM15912's ability to protect and regenerate the gastrointestinal tract positively affects gastrointestinal involvement, the leading cause of death in GVHD.

In another study, HM15912 treatment improved both GVHD score and survival in an animal model of GVHD that was not responsive to steroids. Hanmi believes that these efficacies could provide a new treatment option for patients with steroid-resistant GVHD.

"The development of rare disease treatments is an area that must be pursued with a sense of mission as a pharmaceutical company given the great suffering experienced by patients and their families,” a Hanmi official said. "We will do our best to contribute to the lives of patients with rare diseases by developing innovative new drugs that present a new treatment paradigm."