VectivBio (VECT) Receives FDA Orphan Drug Designation for Apraglutide for Acute Graft-Versus-Host Disease

VectivBio Holding AG, (“Vectiv” or “VectivBio”) (Nasdaq: VECT), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe rare conditions for which there is a significant unmet medical need, today announced that 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, M.D., Ph.D., 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 United States. 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.

You May Also Be Interested In

• Abeona Therapeutics (ABEO) Receives FDA Complete Response Letter on Pz-cel
• enVVeno Medical (NVNO) Reports Positive 11 Month Topline Efficacy Data Showing Significant Clinical Improvement from VenoValve
• HOOKIPA Pharma Inc. (HOOK) Receives FDA Clearance of INDA for HB-700