Phase 2 trials of Hanmi¡¯s two orphan drugs cleared by FDA

Hanmi Pharmaceutical Co. said on Thursday that Phase 2 clinical trials of its two investigational orphan drugs, Glucagon Analog (HM15136) and GLP-2 Analog (HM15912), have been approved by the U.S. Food and Drug Administration (FDA).

The Korean company has developed a once-weekly formulation of Glucagon Analog for the treatment of congenital hyperinsulinism with its proprietary LAPSCOVERY (Long Acting Protein/Peptide Discovery) technology.

Congenital hyperinsulinism is a rare disease that affects one in 50,000 people. There is no approved cure for this disease until now, forcing patients to rely on off-label medicines or surgery.

In 2018, the FDA and the European Medicines Agency (EMA) granted orphan drug designation (ODD) to Glucagon Analog for the treatment of congenital hyperinsulinism. The drug also received ODD from the EMA for the treatment of insulin autoimmune syndrome in 2020 and the FDA designated it as a rare pediatric disease (RPD) medicine.

GLP-2 Analog is being developed as a once-monthly regimen based on LAPSCOVERY technology for the treatment of short bowel syndrome (SBS). SBS occurs when more than 60 percent of the small intestine is disabled due to congenital or surgical reasons, resulting in severe absorption disorders and malnutrition. This rare condition affects approximately 24 per 100,000 live births.

GLP-2 Analog works to boost the growth of villous cells, increasing the patient's nutrient absorption efficiency. The FDA and the EMA granted ODD to GLP-2 Analog for the treatment of SBS. The FDA designated it as an RPD drug in 2020.

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