Biotechnology company Therachon AG said on Wednesday that it has passed the US Food and Drug Administration's (FDA) orphan drug designation for apraglutide for the treatment of short bowel syndrome (SBS).

Short Bowel Syndrome (SBS) results from extensive intestinal resection due to chronic inflammatory bowel disease (IBD), acute events (e.g. mesenteric infarction) or congenital abnormalities. SBS is a severe, chronic condition associated with reduced or complete loss of intestinal function, known as 'intestinal failure'.

The company said apraglutide (FE 203799) is a next-generation, synthetic GLP-2 analog that has undergone extensive preclinical characterization and optimization. It has successfully completed Phase 1 single ascending dose/multiple ascending dose clinical trials in healthy volunteers demonstrating a superior pharmacokinetic profile with a half-life of 30 hours, enabling an easy-to-use, once-weekly dosing regimen. It is currently being investigated in two Phase 2 clinical trials in SBS.

Additionally, apraglutide has received Orphan Drug Designation from the European Commission, concluded the company.