VectivBio initiates phase 3 trial of apraglutide in patients with short bowel syndrome

VectivBio, a leading Swiss biotechnology firm, has announced the commencement of patient dosing in its phase 3 STARS clinical trial. This trial will evaluate the efficacy and safety of apraglutide, a synthetic glucagon-like peptide-2 (GLP-2) analog, in treating patients with Short Bowel Syndrome (SBS) with intestinal failure (SBS-IF). The STARS trial marks the largest phase 3 study ever conducted in this patient population, highlighting its significance in advancing treatment options.

The Strategic Importance of the STARS Trial

The STARS trial is uniquely designed to cater to the individual needs of patients by considering their remnant bowel anatomy and caloric requirements. This approach aims to wean patients off parenteral support effectively. Dr. Kishore Iyer, Chairman of the VectivBio Phase 3 Scientific Steering Committee, emphasized the trial’s innovative design, stating, “The unique design of the STARS trial considers a patient’s remant bowel anatomy when adapting parenteral support and evaluating the clinical impact of apraglutide. This 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.”

Promising Results from Earlier Phases

Apraglutide has previously demonstrated safety and efficacy in phase 2 clinical trials, showing significant improvement in intestinal fluid and nutrient absorption compared to placebo. These promising results have paved the way for the phase 3 trial, which is anticipated to provide more comprehensive data on apraglutide’s benefits.

VectivBio’s Commitment to SBS Patients

Luca Santarelli, CEO of VectivBio, remarked on the unmet needs within the SBS community, noting, “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.”

The initiation of the STARS trial by VectivBio is a significant step forward in the treatment of Short Bowel Syndrome. By focusing on the individual needs of patients and incorporating innovative trial designs, VectivBio is not only advancing medical research but also emphasizing patient-centered care. This approach could potentially set a new standard in the treatment landscape of SBS, offering hope and improved quality of life for patients affected by this challenging condition.