-- Apraglutide well-tolerated and does not require dose-adjustment in patients with severe renal disease --
-- Results demonstrate potential to reach 28% of SBS-IF patients with renal dysfunction who are underserved by currently available therapies --
BASEL, Switzerland, March 29, 2022 (GLOBE NEWSWIRE) -- VectivBio Holding AG (“VectivBio”) (Nasdaq: VECT), a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, today presented new clinical data demonstrating the potential of apraglutide, a next-generation, long-acting GLP-2 analog, as a novel treatment for short bowel syndrome with intestinal failure (SBS-IF) patients who have impaired renal function. The data were presented as a poster at the 2022 American Society for Parenteral and Enteral Nutrition Conference (ASPEN), taking place in Seattle, Washington and virtually on March 26-29, 2022.
Patients with SBS-IF have an increased risk of complications, including approximately 28% who also suffer from renal dysfunction due to recurrent episodes of severe dehydration and their increased risk for kidney stone formation. GLP-2 analogs have been developed to increase nutrient and fluid absorption. However, currently available GLP-2 therapy requires dose reduction and may not be suitable for these patients with moderate and severe renal impairment and end-stage renal disease. Apraglutide was designed with unique pharmacologic properties that result in a long half-life. As a next-generation GLP-2 analog peptide, apraglutide is metabolized into small peptides and amino acids via catabolic pathways, similar to endogenous GLP-2. Therefore, renal elimination does not play a significant role in clearance of apraglutide, as has been shown in prior preclinical and clinical studies demonstrating no intact parent compound present in urine.
“These data presented at ASPEN continue to support apraglutide as a potentially best-in-class GLP-2 analog,” said Omar Khwaja, M.D., Ph.D., Chief Medical Officer of VectivBio. “Importantly, these results are also clinically significant, as they show that apraglutide does not require dose adjustment for SBS-IF patients with and without renal impairment. This demonstrates apraglutide’s potential to reach a sizable subset of SBS-IF patients underserved by currently available therapies, addressing an area of high unmet need and reinforcing our belief that apraglutide may expand the treatable market.”
Details of the e-poster presentation are as follows:
Title: A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects with Normal and Impaired Renal Function
Poster Number: #P73
A single 5 mg dose of apraglutide was well-tolerated in healthy subjects as well as patients with severe renal disease. There was no overexposure of apraglutide in patients with severe renal impairment compared to healthy subjects, supporting prior preclinical and clinical evidence that renal elimination does not play a significant role in clearance of apraglutide. Therefore, apraglutide dose adjustments are not necessary for SBS-IF patients with renal impairment, for whom they may be required with currently available GLP-2 treatments.
About Apraglutide
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. 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. The Company 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 first 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. Lead product candidate apraglutide is a next-generation, long-acting synthetic GLP-2 analog being developed for a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology, including short bowel syndrome with intestinal failure (SBS-IF) and Acute Graft-Versus-Host Disease (aGVHD).
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 (MMA), propionic acidemia (PA), and other organic acidemias.
Learn more at www.vectivbio.com, and follow us on LinkedIn and Twitter.
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 the success of development and commercialization efforts with respect to apraglutide, VectivBio’s lead product, VectivBio’s plans to initiate additional clinical studies of apraglutide, the success of development and commercialization of the CoMET platform, and the ability 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 lead 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.
VectivBio Contacts:
Investors:
Claudia D’Augusta
claudia.daugusta@vectivbio.com
