-FDA clears IND Application for Apraglutide for Acute Graft-Versus-Host Disease
- Dosing of first patient expected in 1Q 2022 -
- Interim data anticipated in 2H 2022 -
- FDA previously granted orphan drug designation for apraglutide for the prevention of acute graft-versus-host disease -
BASEL, Switzerland, Oct. 20, 2021 (GLOBE NEWSWIRE) -- 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.
Acute Graft Versus Host Disease (aGVHD) is a severe, rare condition which occurs when immune cells from the donor attack a recipient's healthy cells after an allogeneic hematopoietic stem cell transplant (HSCT). HSCT is standard last-line treatment for many forms of 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. More than 22,000 allogeneic HSCTs take place in the U.S. and Europe 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, with grades II, III, and IV having ~80%, ~25%, and ~5% survival rates, respectively.
Apraglutide is a next-generation, long-acting, potent, synthetic GLP-2 analog that acts as a selective, full agonist of the GLP-2 receptor. It is an investigational new drug that is currently being evaluated in a pivotal phase 3 clinical trial for patients who have short bowel syndrome with intestinal failure (SBS-IF). Patients with SBS-IF require parenteral support (PS), the intravenous delivery of essential fluids and nutrients, to survive. Apraglutide is designed to enable patients to minimize the burden from PS by increasing intestinal absorption of fluids, calories and nutrients. Based on preclinical and clinical data to date, apraglutide has the potential to advance the treatment of SBS-IF 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. Apraglutide is also being evaluated in steroid-refractory acute graft-versus-host disease (aGVHD) and has demonstrated improvements in survival in pre-clinical aGVHD models. VectivBio anticipates dosing the first patient in a Phase 2 clinical trial of apraglutide for aGVHD in the first quarter of 2022 with interim data expected in the second half of 2022. About VectivBio AG
VectivBio (Nasdaq: VECT) is a global clinical-stage biotechnology company focused on transforming and improving the lives of patients with severe rare conditions. Our lead product candidate, apraglutide, is a next-generation GLP-2 analog currently in a global Phase 3 clinical trial for short bowel syndrome with intestinal failure (SBS-IF). It is being developed for a range of rare gastrointestinal diseases where GLP-2 plays a central role in disease pathophysiology, including Acute Graft-Versus-Host Disease (aGVHD).
With the CoMET platform, we also aim to address severe and often fatal Inherited Metabolic Diseases (IMDs) in pediatric populations. IMDs represent a group of genetic disorders in which dysregulated Co-enzyme A (CoA) metabolism is a factor. Candidates from the CoMET platform are initially being evaluated in methylmalonic acidemia (MMA) and propionic acidemia (PA). Additional targets include urea cycle disorders, fatty acid oxidation disorders, and amino acidopathies.
Forward Looking StatementsForward-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 acquisition of Comet Therapeutics and the prospects of its platform, the success of development and commercialization efforts with respect to VectivBio's product candidate and VectivBio's plans to initiate additional clinical studies of apraglutide and to expand its rare disease product portfolio. 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 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 candidate 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 Registration Statement on Form F-1 declared effective by the Securities and Exchange Commission on April 8, 2021 and its other subsequent filings with the Securities and Exchange Commission. 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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