VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to evaluate apraglutide, a next-generation, long-acting GLP-2 analog, in a Phase 2 clinical trial called STARGAZE (Study of Apraglutide in Graft-Versus-Host Disease), for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD).
Apraglutide previously received orphan drug designation by the FDA for the prevention of aGVHD in June.
“Acute graft-versus-host disease typically emerges within the first 100 days after a hematopoietic stem cell transplant and is associated with a high mortality rate,” said Omar Khwaja, M.D., Ph.D., Chief Medical Officer of VectivBio. “We have demonstrated promising preclinical results with apraglutide as a novel approach to treating acute graft-versus-host disease, showing a significant reduction in mortality after treatment with apraglutide in mouse models. We are encouraged by this preliminary data and look forward to dosing the first patient in a Phase 2 clinical trial in 1Q 2022.”
“Despite significant advances in managing steroid-refractory graft-versus-host disease, there still remains a high unmet need to develop non-immunosuppressive treatment options specifically targeting the GI tract, one of the primary tissue systems damaged in acute graft-versus-host disease,” said Prof. Robert Zeiser, Head of Tumor Immunology and Immune Modulation at the University Medical Center Freiburg. “I believe that apraglutide represents a potentially transformative new therapeutic option for acute graft-versus-host disease patients thanks to its GLP-2 receptor mediated effects on protecting and regenerating Paneth cells and intestinal stem cells.”
STARGAZE, a Phase 2, randomized, double-blind study, will assess the safety, tolerability, pharmacokinetic profile and efficacy of apraglutide in patients with steroid-refractory aGVHD. Dosing of the first patient is expected in 1Q 2022. Interim data read out is anticipated for 2H 2022.