BASEL, Switzerland, June 24, 2021 (GLOBE NEWSWIRE) — VectivBio Holding AG, (“Vectiv” or “VectivBio”) (Nasdaq: VECT), a medical stage biopharmaceutical firm centered on the invention, improvement and commercialization of revolutionary therapies for extreme uncommon situations for which there’s a major unmet medical want, as we speak introduced that the FDA has granted orphan drug designation to apraglutide, a next-generation, long-acting GLP-2 analog being developed for uncommon gastrointestinal (GI) ailments, for the prevention of acute graft-versus-host illness (aGVHD). GVHD is a extreme, uncommon situation which may consequence from receiving an allogeneic hematopoietic stem cell transplant and the immune cells from the donor assault the affected person’s wholesome cells. VectivBio plans to provoke a Part 2 trial evaluating apraglutide for the remedy of aGVHD within the first quarter of 2022.
“Gastrointestinal harm is a number one reason behind dying in sufferers with acute GVHD,” stated Omar Khwaja, M.D., Ph.D., Chief Medical Officer of VectivBio. “Preclinical and medical research evaluating apraglutide and GLP-2 analogs in acute GVHD point out that apraglutide’s regenerative and anti inflammatory results on the GI tract might considerably cut back morbidity and mortality in sufferers affected by intestinal GVHD. We’re desirous to assess apraglutide’s potential to forestall and deal with this life-threatening illness and stay up for sharing our Part 2 plans later this 12 months.”
The FDA’s Orphan Drug Designation program is designed to advance the event of medication and biologics meant to deal with, forestall or diagnose uncommon ailments affecting lower than 200,000 individuals in america. Orphan Drug Designation incentives and advantages might embody seven years of market exclusivity post-regulatory approval, tax credit for certified medical trial bills and a waiver of the Prescription Drug Person Charge Act (PDUFA) submitting price.
About VectivBio AG
VectivBio (Nasdaq:VECT) is a world, clinical-stage biotechnology firm centered on the invention, improvement and commercialization of revolutionary therapies for extreme uncommon situations with excessive unmet medical want. The corporate is dedicated to pursuing product candidates with a transparent mechanism of motion and the potential to meaningfully rework and enhance the lives of sufferers and their households. VectivBio’s product candidate, apraglutide, is a next-generation GLP-2 analog being developed as a differentiated therapeutic for a variety of uncommon gastrointestinal (GI) ailments. Apraglutide is presently being evaluated in a world Part 3 medical trial as a once-weekly remedy for brief bowel syndrome with intestinal failure (SBS-IF). VectivBio additionally plans to provoke medical research of apraglutide in further indications, together with graft-versus-host illness, the place GLP-2 is believed to be central to illness pathophysiology.
Ahead Trying Assertion
Ahead-looking statements are statements that aren’t historic info. Phrases and phrases corresponding to “anticipated,” “ahead,” “will,” “would,” “might,” “stay,” “potential,” “put together,” “anticipated,” “consider,” “plan,” “close to future,” “perception,” “steering,” and related expressions are meant to determine forward-looking statements. These statements embody, however should not restricted to, statements regarding the success of improvement and commercialization efforts with respect to VectivBio’s product candidate; and VectivBio’s skill to develop its uncommon illness product portfolio. All of such statements are topic to sure dangers and uncertainties, a lot of that are troublesome to foretell and customarily past VectivBio’s management, that would trigger precise outcomes to vary materially from these expressed in, or implied or projected by, the forward-looking info and statements. Such dangers and uncertainties embody, however should not restricted to: the impacts of the continuing COVID-19 pandemic, together with interruptions or different opposed results on medical trials and delays in regulatory assessment; delay in or failure to acquire regulatory approval of VectivBio’s product candidate and profitable compliance with FDA and different governmental laws relevant to product approvals; the dangers inherent in drug improvement and in conducting medical trials; and people dangers and uncertainties recognized within the “Threat Elements” part of VectivBio’s Registration Assertion on Type F-1 declared efficient by the Securities and Change Fee on April 8, 2021 and its different subsequent filings with the Securities and Change Fee. All forward-looking statements contained on this press launch communicate solely as of the date on which they have been made. Besides to the extent required by legislation, VectivBio undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they have been made.
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