VectivBio Announces First Two Patients Dosed in Phase 2 STARGAZE Study of Apraglutide for the Treatment of Acute Graft-versus-Host Disease
– Interim proof-of-concept data anticipated from STARGAZE in H1 2023
– First-in-class regenerative, non-immunosuppressive approach to treating acute Graft-versus-Host Disease
– Second clinical indication under evaluation for apraglutide, demonstrating broad potential of this next generation GLP-2 analog beyond short bowel syndrome with intestinal failure
BASEL, Switzerland, June 02, 2022 (GLOBE NEWSWIRE) -- VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today announced the first two patients have dosed in STARGAZE, a Phase 2 clinical trial evaluating apraglutide, a next-generation, long-acting GLP-2 analog, in patients with steroid-refractory gastrointestinal (GI) acute Graft-versus-Host Disease (aGvHD), a life-threatening condition that occurs when immune cells from the donor attack a recipient’s healthy cells after an allogeneic hematopoietic stem cell transplant (HSCT).
“Acute GvHD is associated with high morbidity and mortality resulting in significant part from GI damage which occurs in the majority of patients. There is a significant need for more effective and non-immunosuppressive therapies to ensure greater success of allogeneic hematopoietic stem cell transplants, an important definitive treatment for many forms of blood cancer,” said Robert Zeiser, M.D., Professor of Hematology and Oncology at the University of Freiburg and Principal Investigator for the STARGAZE study. “There is a strong rationale to target GLP-2 in this indication given its ability to protect against gut damage and potentially regenerate the GI tract. We have generated compelling preclinical and clinical data supporting the use of GLP-2 analogs as a novel and potentially transformative approach to treating aGvHD patients.”
GLP-2 promotes intestinal healing and regeneration through intestinal epithelial repair, restoration of intestinal barrier function, and maintaining a healthy microbiome. Preclinical studies in aGvHD animal models suggest apraglutide may protect the GI tract, reduce mortality, and repair damage from conditioning, stem cell transplantation, and aGvHD. Clinical use of other GLP-2 analogs in patients with steroid-refractory aGvHD demonstrated marked improvement in GI aGvHD symptoms such as frequency of diarrhea and serum albumin levels, a parameter indicating patients’ intestinal barrier integrity and nutritional status.
“With the dosing of the first two patients in the STARGAZE Study, we are excited to begin evaluating apraglutide, our next generation GLP-2 analog, for treatment of acute GvHD. We believe apraglutide, which received orphan drug designation from the FDA for the prevention of acute GvHD, offers a potential first-in-class approach to treating aGvHD. We look forward to sharing interim data from STARGAZE in the first half of 2023,” said Omar Khwaja, M.D., Ph.D., Chief Medical Officer of VectivBio. “This study further establishes the broad potential of our lead candidate in treating severe diseases of the gut, as aGvHD is the second clinical indication we are studying with apraglutide. We plan to continue exploring the potential of apraglutide across a range of GI and other conditions where GLP-2 plays a central role.”
STARGAZE (Study of Apraglutide in Graft-versus-Host Disease) is a randomized, double-blind, Phase 2 study designed to evaluate weekly dosing of apraglutide in combination with systemic corticosteroids and ruxolitinib in patients with steroid-refractory gastrointstinal aGvHD for up to 90 days. The trial is expected to enroll approximately 36 patients. It will measure safety and tolerability, pharmacokinetics, and efficacy, including response rate, duration of response, and survival-related outcomes. The study has been designed to have the potential to be rapidly adapted to a pivotal study. VectivBio expects to report interim data in the first half of 2023.
Acute Graft-versus-Host Disease (aGvHD) is a severe condition which occurs when immune cells from the donor attack a recipient’s healthy cells after an allogeneic hematopoietic stem cell transplant (HSCT), the standard last-line treatment for many forms of blood cancer. aGvHD typically emerges within the first 100 days post-transplant and predominantly affects the skin, gastrointestinal (GI) tract and liver. GI GvHD is one of the leading causes of morbidity and mortality following HSCT. The predominant manifestations of GI GvHD are abdominal pain and diarrhea. The diarrhea is secretory, occurs independently of oral intake and can be profound and incessant, with up to several liters of output and more than 10 episodes per day, often requiring parenteral support to feed and hydrate patients. More than 26,000 allogeneic HSCTs take place in the U.S., Europe and Japan annually and aGvHD occurs in an estimated 30-50% of patients. Corticosteroids are the first line standard of care for aGvHD, but approximately half of patients will become steroid-refractory. Mortality of 30% at 12-months in steroid-refractory aGvHD patients is driven by the severity of GI symptoms.
Apraglutide is a next-generation, synthetic GLP-2 analog rationally designed with the potential to offer an improved safety and efficacy profile relative to other agents in its class and less frequent dosing. VectivBio is pursuing a novel clinical strategy across a range of applications for apraglutide, beginning with STARS, a global Phase 3 program for the treatment of short bowel syndrome with intestinal failure (SBS-IF).
SBS-IF patients live with a burdensome standard of care, often requiring routine parenteral support (PS), the intravenous delivery of essential fluids and nutrients, to survive. A heterogenous population, the therapeutic needs and patient journey differ depending on an individual’s remnant bowel anatomy (stoma or colon-in-continuity (CIC)). Apraglutide has the potential to advance the treatment of SBS-IF by establishing less frequent dosing and increasing intestinal absorption of fluids, calories and nutrients, leading to improved clinical outcomes and quality of life for patients across the anatomical spectrum that characterizes the disease. VectivBio expects to report topline data from the Phase 3 trial in the second half of 2023, and interim results from STARS Nutrition, a multicenter, open-label metabolic balance study of apraglutide designed to evaluate the efficacy of once-weekly apraglutide in increasing intestinal energy absorption and reducing the parenteral support requirement in patients with SBS-IF CIC in the second half of 2022.
About VectivBio AG
VectivBio is also advancing its modular, small molecule CoMET platform to address a broad range of previously undruggable Inherited Metabolic Diseases (IMDs). CoMET leverages innovative chemistry, based on a proprietary stabilized pantetheine backbone, to restore fundamental cellular metabolism in pediatric populations with IMDs characterized by a deficit of energy metabolism caused by the depletion of functional Coenzyme A (“CoA”). Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia, propionic acidemia, and other organic acidimias.
Forward Looking Statements
Forward-looking statements are statements that are not historical facts. Words and phrases such as “anticipated,” “forward,” “will,” “would,” “may,” “remain,” “potential,” “prepare,” “expected,” “believe,” “plan,” “near future,” “belief,” “guidance,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements concerning the clinical development of apraglutide, as well as potential upcoming data readouts from its clinical trials, and statements regarding VectivBio’s CoMET platform. All of such statements are subject to risks and uncertainties, many of which are difficult to predict and generally beyond VectivBio’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. Such risks and uncertainties include, but are not limited to: the impacts of the Russian/Ukrainian war and the ongoing COVID-19 pandemic, including interruptions or other adverse effects on clinical trials and delays in regulatory review; delay in or failure to obtain regulatory approval of VectivBio’s product candidates and successful compliance with FDA and other governmental regulations applicable to product approvals; the risks inherent in drug development and in conducting clinical trials; and those risks and uncertainties identified in the “Risk Factors” section of VectivBio’s Annual Report for the year ending December 31, 2021 on Form 20-F filed with the Securities and Exchange Commission on April 7, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, VectivBio undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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