Biogen Halts Mid-Stage IPF Drug Trial Due to Safety Concerns

Halt

The hits keep coming for Biogen. Days after the Cambridge-based company halted its BACE inhibitor program for Alzheimer’s disease, the company stopped another clinical trial in idiopathic pulmonary fibrosis due to safety reasons.

First reported by Andrew Dunn of Biopharmadive on Twitter, Biogen noted on clinicaltrials.gov that the mid-stage trial assessing the experimental drug BG00011 against placebo had to be halted for safety concerns. Biogen said on the government website that end-of-study and safety follow-up visits are currently in progress. Biogen acquired the human monoclonal antibody BG00011 in 2012 when the company snapped up Stromedix in a $562.5 million deal. BG00011 was designed to selectively disrupt the TGF-beta pathway, which plays a central role in fibrotic disease.

The drug took some time to enter Phase II, but the objective of the trial that has now been halted was to evaluate the efficacy of BG00011, along with several secondary objectives. The secondary objectives included assessing the efficacy of the drug compared to placebo in IPF patients as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC greater than 10% in participants who receive BG00011 compared with placebo, among others.

Idiopathic pulmonary fibrosis (IPF) is a fatal disease caused by progressive scarring of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly. The disease can advance quickly or slowly, but eventually, the lungs will harden and stop working altogether. There is no known cure for IPF. The median survival time from diagnosis is two to five years, and the five-year survival rate is approximately 20 to 40%.

As noted on Seeking Alpha, RBC's Brian Abrahams said expectations for the Biogen IPF drug were low, which means there is not an expectation axing the trial will negatively impact the company’s stock. However, Abrahams did say that the fate of BG00011 points out the “relatively high-risk nature of Biogen's pipeline and removes a potential diversification opportunity.”

Biogen had hoped to use the drug to enter a space with few approved products, such as Boehringer Ingelheim’s Ofev (nintedanib), which was first approved for IPF in 2014. Only days ago, the U.S. Food and Drug Administration approved Ofev for systemic sclerosis-associated interstitial lung disease. It is the first and only drug approved for this indication. The other drug approved by the FDA for IPF is Genentech’s Esbriet. That drug, first developed by Brisbane, Calif.-based InterMune, was approved in 2014, two months after Roche acquired the company in an $8.3 billion deal. Esbriet, which was approved under Breakthrough Therapy Designation, inhibits with the production of Transforming Growth Factor-beta, a small protein in the body involved in how cells grow and Tumor Necrosis Factor (TNF)-alpha, a small protein that is involved in inflammation.

While Biogen scrapped its IPF drug trial, other companies are in-line to challenge Boehringer Ingelheim and Genentech. In May, AstraZeneca’s IPF-focused saracatinib received Orphan Drug Designation from the FDA. Saracatinib, which is Phase II-ready, is an inhibitor of src kinase which regulates broad cell functions including cell growth and cell differentiation, according to the company.

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