Clinical Trials

Date: 2021-10-20

Type of information: Clinical trial authorisation

phase: 2

Announcement: authorization of the trial

Company: Vectivbio (Switzerland)

Product: apraglutide

Action mechanism: GLP2 analog Apraglutide has demonstrated improvements in survival in pre-clinical aGVHD models.

Disease: acute graft-versus-host disease

Therapeutic area: Transplantation

Country: USA

Trial details: 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.

Latest news:

• On October 20, 2021, VectivBio, a clinical-stage biopharmaceutical company pioneering novel transformational treatments for severe rare conditions, announced that the 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.

   

Is general: Yes