VectivBio Gets FDA Clearance for IND of Apraglutide

Published: 2021-10-20 07:40:02 ET VECT

By Chris Wack

VectivBio Holding AG said the U.S. Food and Drug Administration has cleared its Investigational New Drug application to evaluate apraglutide, a next-generation, long-acting GLP-2 analog, in a Phase 2 clinical trial for the treatment of steroid-refractory acute graft-versus-host disease.

Apraglutide previously received orphan drug designation by the FDA for the prevention of aGVHD in June.

The biopharmaceutical company said it plans to start dosing the first patient in a Phase 2 clinical trial in the first quarter of 2022.

The Phase 2 study will assess the safety, tolerability, pharmacokinetic profile and efficacy of apraglutide in patients with steroid-refractory aGVHD. Interim data read out is anticipated for the second half of 2022.

VectivBio shares were up 2%, to $6.48, in premarket trading.

Write to Chris Wack at [email protected]

(END) Dow Jones Newswires

10-20-21 0739ET