- Biogen confirmed Tuesday it ended a Phase 2b study early for an experimental treatment for idiopathic pulmonary fibrosis, or IPF, citing safety concerns with the drug.
- RBC Capital Markets analyst Brian Abrahams flagged the trial discontinuation Monday, which appears to have been the only active trial for the monoclonal antibody called BG00011 and, formerly, STX-100. Biogen determined the drug's benefit-risk profile "no longer met the criteria to continue the clinical trial," a company spokesperson said in a statement to BioPharma Dive.
- IPF patients suffer progressively declining lung function due to scarring from the chronic and irreversible disease. Biogen acquired the antibody in 2012, when the company bought the privately-held biotech Stromedix.
Biogen keeps fumbling in its search for a future without aducanumab, its now-discontinued Alzheimer's drug.
BG00011 did not carry high expectations from investors, but the failure "does underscore some of the relatively high-risk nature" of the biotech's pipeline, Abrahams noted Monday.
If that risk wasn't previously apparent to investors, 2019 has made it clear. Biogen's stock has fallen by about 23% since the beginning of the year, translating to a loss in market value of more than $15 billion.
Most of that decline stems from a drop in March, when Biogen and its partner Eisai discontinued late-stage studies of aducnanumab, which was widely seen as the most promising anti-amyloid drug in development.
Pipeline setbacks in the disease have continued, too. Less than a week ago, the drugmakers stopped two studies of another experimental Alzheimer's drug, elenbecestat, after a data review found an "unfavorable risk-benefit ratio."
Now, a trial of BG00011 has been cut short.
The drug was originally developed by Stromedix, a biotech founded and ran by a former Biogen executive, Michael Gilman.
Biogen paid $75 million upfront to acquire Stromedix in 2012, lining up nearly $500 million in potential milestone payments. Phase 2b testing of BG00011 began in September 2018, triggering an $81.5 million payment to Stromedix's former shareholders.
While outside of Biogen's long-time neuroscience focus, the lung disease drug slowly grew in prominence throughout this year, as the company highlighted its R&D work outside of Alzheimer's.
Quarterly company presentations tell that story well. In January, BG00011 was listed under "Other" on a pipeline summary slide, distinct from areas Biogen had marked as core and emerging growth.
But rather than shift its strategy significantly this year, Biogen has instead focused on share buybacks until its earlier-stage pipeline can produce, Credit Suisse analyst Evan Seigerman wrote in July.
"We are concerned that management does not seem willing to implement a larger structural change in strategy," Seigerman added, arguing M&A is needed as pressure grows on the company's business in multiple sclerosis and spinal muscular atrophy.
One potential target is now off the board, after Danish drugmaker Lundbeck this week acquired migraine specialist Alder BioPharmaceuticals — a deal which RBC's Abrahams called a "missed opportunity" for Biogen.