Apraglutide Receives Orphan Drug Designation for Short Bowel Syndrome
The European Commission has granted an orphan drug designation to Therachon’s apraglutide for the treatment of short bowel syndrome, according to a company press release.
Apraglutide (FE 203799) – a next-generation, synthetic GLP-2 analog – has demonstrated a superior pharmacokinetic profile with a half-life of 30 hours across multiple phase 1 single ascending dose/multiple ascending dose clinical trials in healthy volunteers, according to the release.
Two phase 2 clinical trials are currently evaluating the use of apraglutide in patients with short bowel syndrome.
“We are pleased to receive this designation, which was granted upon reviewing both preclinical study results from ... phase 2 clinical trial data obtained with weekly dosing of apraglutide in patients with short bowel syndrome,” Luca Santarelli, MD, CEO of Therachon, said in the release. “We believe that apraglutide’s orphan drug designation is consistent with its potential to become the best-in-class therapeutic for the treatment of SBS.”