VectivBio Receives FDA Orphan Drug Designation for Apraglutide for Acute Graft-Versus-Host Disease
VectivBio Holding AG (Nasdaq: VECT) announced that the FDA granted orphan drug designation to apraglutide, a long-acting GLP-2 analog, for preventing acute graft-versus-host disease (aGVHD). This designation is significant for treating rare gastrointestinal diseases. VectivBio plans to initiate a Phase 2 trial in the first quarter of 2022 to assess apraglutide's potential in treating aGVHD. The FDA's orphan drug designation provides benefits such as seven years of market exclusivity and tax credits. Apraglutide is also evaluated for other indications, including treatment for short bowel syndrome.
- FDA granted orphan drug designation to apraglutide for aGVHD.
- Plans to initiate Phase 2 trial in Q1 2022 to assess treatment effectiveness.
- Potential for seven years of market exclusivity post-approval.
- Tax credits available for qualifying clinical trial expenses.
- None.
Phase 2 trial expected to begin in the first quarter of 2022
BASEL, Switzerland, June 24, 2021 (GLOBE NEWSWIRE) -- 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.
About VectivBio AG
VectivBio (Nasdaq:VECT) is a global, clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative treatments for severe rare conditions with high unmet medical need. The company is committed to pursuing product candidates with a clear mechanism of action and the potential to meaningfully transform and improve the lives of patients and their families. VectivBio’s product candidate, apraglutide, is a next-generation GLP-2 analog being developed as a differentiated therapeutic for a range of rare gastrointestinal (GI) diseases. Apraglutide is currently being evaluated in a global Phase 3 clinical trial as a once-weekly treatment for short bowel syndrome with intestinal failure (SBS-IF). VectivBio also plans to initiate clinical studies of apraglutide in additional indications, including graft-versus-host disease, where GLP-2 is believed to be central to disease pathophysiology.
Forward Looking Statement
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 success of development and commercialization efforts with respect to VectivBio’s product candidate; and VectivBio’s ability to expand its rare disease product portfolio. All of such statements are subject to certain 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 information and 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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FAQ
What is the significance of the FDA's orphan drug designation for VectivBio's apraglutide?
When will VectivBio begin the Phase 2 trial for apraglutide?
What is acute graft-versus-host disease?
What are the potential benefits of apraglutide according to the press release?
What are the additional indications for apraglutide under evaluation?
