VectivBio begins phase 3 trial of apraglutide in short bowel syndrome
VectivBio has dosed the first patient in its phase 3 STARS clinical trial of its synthetic GLP-2 analog apraglutide in short bowel syndrome (SBS).
The Swiss clinical-stage biotech company said that the STARS trial is the largest phase 3 trial to be ever held in short bowel syndrome with intestinal failure (SBS-IF).
The late-stage trial will assess a weekly once dosing interval and for taking into account remnant bowel anatomy and individual caloric requirements during weaning patients off of parenteral support.
Dr. Kishore Iyer – Chairman of VectivBio phase 3 Scientific Steering Committee said: “The unique design of the STARS trial considers a patient’s remnant bowel anatomy when adapting parenteral support and evaluating the clinical impact of apraglutide. Remnant bowel anatomy is highly relevant to fully harness the therapeutic potential of apraglutide across the diverse spectrum of SBS patients, potentially offering better information on how to use apraglutide in distinct patient subtypes.”
In its phase 2 clinical program, apraglutide in two independent trials was shown to be safe and well tolerated, while achieving clinically meaningful improvement in intestinal fluid and nutrient absorption, when compared to placebo.
According to VectivBio, Apraglutide is designed to help patients in minimizing the burden from parenteral support by boosting intestinal absorption of fluids, calories, and nutrients.
Luca Santarelli – CEO of VectivBio said: “SBS is a devastating and life-threatening condition with great unmet medical need, for which the standard-of-care presents a significant daily burden for people living with SBS, their families and caregivers.
“We are excited to commence patient dosing in our pivotal phase 3 trial which was designed with feedback from the FDA and the EMA. We see the potential for apraglutide to become the best-in-class GLP-2 analog.”