Randomized Phase IIa Clinical Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis

Patients with IPF typically tolerated the once-weekly subcutaneous treatment of BG00011 at doses less than 1.0 mg/kg well in this short phase lla research. However, patients receiving greater dosages of BG00011 experienced abrupt IPF exacerbation. A potential risk of respiratory status deterioration...

Full description

Saved in:
Bibliographic Details
Published in:American journal of respiratory and critical care medicine 2022-11, Vol.206 (9), p.1166-1168
Main Authors: Raghu, Ganesh, Mouded, Majd, Prasse, Antje, Stebbins, Christopher, Zhao, Guolin, Song, Guochen, Arefayene, Million, Violette, Shelia M, Gallagher, Diana, Gibson, Kevin F
Format: Article
Language:English
Subjects:
Chemical compounds
Clinical trials
Correspondence
Drug therapy
Monoclonal antibodies
Pulmonary fibrosis
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Patients with IPF typically tolerated the once-weekly subcutaneous treatment of BG00011 at doses less than 1.0 mg/kg well in this short phase lla research. However, patients receiving greater dosages of BG00011 experienced abrupt IPF exacerbation. A potential risk of respiratory status deterioration with greater dosages of BG00011 was also identified by the trial, which met the predetermined stopping criteria at the dose of 3.0 mg/kg. The findings imply that BG00011's targeting of the avp6-integrin reduces TGF-P activation and may stop fibrogenesis. Biological activity was demonstrated by the inhibitory effect of BG00011 on pSMAD2 expression in BAL cells, starting at the dose of 0.3 mg/kg and reaching >70% reduction at 1.0 mg/kg. The biological reaction of BG00011 was similar to that of mice and primates (7).
ISSN:1073-449X
1535-4970
DOI:10.1164/rccm.202205-0868LE