Biogen halts mid-stage study of BG00011 in idiopathic pulmonary fibrosis over safety concerns

Biogen stopped a Phase II study of the experimental drug BG00011 in patients with idiopathic pulmonary fibrosis (IPF) due to "safety concerns," according to an update on ClinicalTrials.gov. The trial was initiated in September last year and had been expected to recruit up to 290 subjects with IPF.

The study had enrolled 109 patients to date, with participants randomised to receive a once-weekly subcutaneous injection of BG00011 for 52 weeks or placebo. In addition to the primary endpoint assessing the efficacy of BG00011 versus placebo, the trial's secondary objectives included change in percent predicted forced vital capacity (FVC), progression-free survival, the occurrence of IPF exacerbations and the incidence of absolute decline in FVC of 10% or more.

Biogen gained BG00011, previously known as STX-100, as part of a 2012 deal potentially worth more than $560 million to buy Stromedix. The monoclonal antibody, which is designed to selectively disrupt the TGF-beta pathway, was originally being developed by Biogen before Stromedix licensed it in 2007.

Other companies developing drugs to treat IPF through reducing the activity of TGF-beta include Pliant Therapeutics, which announced results earlier this year from a Phase Ib study of the experimental compound PLN-74809. At the time, chief medical officer Éric Lefebvre said the company will "initiate our Phase IIa programme…in the second half of 2019."   

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