Biogen axes phase 2 study of lung-scarring med due to 'safety concerns'

biogen
“Study was stopped because of safety concerns. End-of-study and safety follow-up visits are in progress,” read an update posted to Biogen's fibrosis study on ClinicalTrials.gov. (Biogen)

When Biogen snapped up Stromedix back in 2012, it was a homecoming of sorts. For $75 million upfront, the Big Biotech regained a drug it had licensed out to Stromedix, where it became the lead program targeting the lung-scarring disease idiopathic pulmonary fibrosis (IPF). Seven years later, Biogen has pulled the plug on a phase 2 study of the treatment due to “safety concerns.” 

“Study was stopped because of safety concerns. End-of-study and safety follow-up visits are in progress,” read an update posted to the study on ClinicalTrials.gov. Biogen confirmed the study’s halt to RBC Capital Markets analysts, who flagged it Monday afternoon. 

Stromedix—which was founded and helmed by Michael Gilman, the former research chief at Biogen—picked up the drug to go after IPF and other types of fibrosis. The company had raised $29.4 million in venture dollars to advance the program, dubbed STX-100, with its investors committing up to $15.5 million in debt to see it through phase 2, Xconomy reported in 2011. But by the time Biogen came knocking the following year, the phase 2-ready program had still not entered midphase trials. 

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Back at Biogen, STX-100 became BG00011. The monoclonal antibody, which targets the integrin alpha V beta 6, entered a phase 2 study for IPF last year. This weekend, with just over one-third of its patients enrolled, Biogen ended the study. 

RELATED: Looking for Ofev follow-up, Boehringer picks up Bridge Biotherapeutics' IPF med for $50M 

The RBC Capital Markets analysts don’t see the news tanking Biogen’s stock, though.

“This was not one of [Biogen's] higher-profile pipeline agents. However, it had recently become more prominently featured (alongside 2 lupus assets) as part of their efforts to consider therapeutic adjacencies beyond neuro and a possible push into l&l/fibrosis,” they wrote. 

“Given low expectations, we believe news of '011's discontinuation in its primary indication should have little impact on shares or valuation, though it does underscore some of the relatively high-risk nature of [Biogen's] pipeline and removes one of their potential internal diversification opportunities.” 

BG00011 was Biogen’s stab at a space with just two FDA-approved drugs—Boehringer Ingelheim’s Ofev and Genentech’s Esbriet—that work by delaying disease progression, but do not cure IPF. Boehringer recently teamed up with South Korea’s Bridge Biotherapeutics to develop a drug that blocks autotaxin, an enzyme that plays a role in promoting scarring in multiple cell types.

Not to be left out, Roivant spawned another “vant” around IPF in September last year—Respivant Sciences is built around an inhaled drug from Patara Pharma for treating chronic cough in patients with IPF. 

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