The first patient has been dosed in its pivotal phase 3 trial of apraglutide in short bowel syndrome (SBS). Apraglutide is an investigational drug being developed as a once-weekly treatment for patients who have SBS with intestinal failure (SBS-IF). It is a next-generation, long-acting, potent, synthetic GLP-2 analog that acts as a selective, full agonist of the GLP-2 receptor.
Apraglutide is designed to enable patients to minimize the burden from parenteral support by increasing intestinal absorption of fluids, calories and nutrients. Apraglutide has successfully completed phase 2 studies and is currently being evaluated in a pivotal phase 3 clinical trial. Based on preclinical and clinical data to date, apraglutide has the potential to advance the treatment SBS-IF (chronic intestinal failure), by establishing less frequent dosing and improving outcomes in a clinically meaningful fashion to address the needs of patients across the anatomical spectrum that characterizes the disease.
"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," said Dr Luca Santarelli, Chief Executive Officer of VectivBio. "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 phase 3 STARS (STudy of ApRaglutide in SBS) trial is a global clinical trial that represents the largest phase 3 trial ever conducted in short bowel syndrome with intestinal failure (SBS-IF). STARS is the first trial designed to exclusively evaluate a once-weekly dosing interval and to take into account remnant bowel anatomy and individual caloric needs during weaning patients off of parenteral support.
"SBS-IF is a condition that requires deep understanding of the unique clinical presentation and the need for individualised assessment," said Dr Kishore Iyer, Chairman of the VectivBio phase 3 Scientific Steering Committee supporting the design and conduct of the STARS trial. "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. We look forward to further clinical investigation of apraglutide and its potential to positively impact the quality of life and transform the care for people with SBS."
The phase 2 clinical program for apraglutide included two independent trials evaluating the safety and efficacy of once-weekly administration in patients with SBS. Apraglutide was found to be safe and well tolerated in both trials and achieved clinically meaningful improvement in intestinal fluid and nutrient absorption compared with placebo. The trials supported the potential advantages of apraglutide on energy absorption to improve outcomes for patients with SBS.