VectivBio Receives FDA Orphan Drug Designation for Apraglutide for Acute Graft-Versus-Host Disease
VectivBio Holding AG recently announced the FDA has granted orphan drug designation to apraglutide, a next-generation, long-acting GLP-2 analog being developed for rare gastrointestinal (GI) diseases, for the prevention of acute graft-versus-host disease (aGVHD). GVHD is a severe, rare condition which can result from receiving an allogeneic hematopoietic stem cell transplant and the immune cells from the donor attack the patient’s healthy cells. VectivBio plans to initiate a Phase 2 trial evaluating apraglutide for the treatment of aGVHD in the first quarter of 2022.
“Gastrointestinal damage is a leading cause of death in patients with acute GVHD,” said Omar Khwaja, MD, PhD, Chief Medical Officer of VectivBio. “Preclinical and clinical studies evaluating apraglutide and GLP-2 analogs in acute GVHD indicate that apraglutide’s regenerative and anti-inflammatory effects on the GI tract may significantly reduce morbidity and mortality in patients suffering from intestinal GVHD. We are eager to assess apraglutide’s potential to prevent and treat this life-threatening disease and look forward to sharing our Phase 2 plans later this year.”
The FDA’s Orphan Drug Designation program is designed to advance the development of drugs and biologics intended to treat, prevent, or diagnose rare diseases affecting less than 200,000 people in the US. Orphan Drug Designation incentives and benefits may include seven years of market exclusivity post-regulatory approval, tax credits for qualified clinical trial expenses and a waiver of the Prescription Drug User Fee Act (PDUFA) filing fee.
VectivBio is a global, clinical-stage biotechnology company focused on the discovery, development, and commercialization of innovative treatments for severe rare conditions with high unmet medical need. The company is committed to pursuing product candidates with a clear mechanism of action and the potential to meaningfully transform and improve the lives of patients and their families. VectivBio’s product candidate, apraglutide, is a next-generation GLP-2 analog being developed as a differentiated therapeutic for a range of rare gastrointestinal (GI) diseases. Apraglutide is currently being evaluated in a global Phase 3 clinical trial as a once-weekly treatment for short bowel syndrome with intestinal failure (SBS-IF). VectivBio also plans to initiate clinical studies of apraglutide in additional indications, including graft-versus-host disease, where GLP-2 is believed to be central to disease pathophysiology.
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