July 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Massachusetts-based Biogen has slipped a former lupus drug candidate back into clinical testing.
The drug, BIIB068, is in a Phase I clinical trial to evaluate the safety and tolerability of the drug in healthy patients. It was just updated on the ClinicalTrials.gov website on July 12, will enroll approximately 52 people, and is expected to start in August 2016 and end in December.
Back in October 2015, Biogen announced restructuring, slashing 11 percent of its workforce and a number of programs. It laid off about 880 people in order to save about $250 million in operating costs. The programs cut included its Phase III program for Tecfidera in secondary progressive multiple sclerosis (MS), its anti-TWEAK program in lupus nephritis, and other programs in immunology and fibrosis research.
BIIB068 is a Bruton’s tyrosine kinase (Btk) inhibitor. Analysts at Jefferies first reported the trial in a note to clients, indicating that although lupus is a difficult condition to treat and develop therapies for, Btk inhibitors have been promising in early trials. According to Market Exclusive, “The inhibitor managed to stop the progress of SLE (systemic lupus erythematosis) for eight weeks, as determined by histologic and functional analyses of glomerulonephritis.”
There is a Btk inhibitor already on the market by Pharmacyclics (owned by AbbVie ) and Janssen, a Johnson & Johnson company, called Imbruvica (ibrutinib). However, Ibruvica is not licensed to treat lupus, but is used to treat blood cancer.
Andy Parker, writing for Market Exclusive, says, “A fear years ago, GlaxoSmithKline plc became the first drug maker in more than a half-century to gain approval of a new treatment for lupus in the form of Benlysta. The drug is a human monoclonal antibody that targets the B-lymphocyte stimulator. It has struggled to make an impact for the company since it got FDA approval in 2011.”
Biogen, which dominates the MS market, has bet on several high-risk drugs, including treatments for Alzheimer’s. They tend to be very high-risk and high-reward. Unfortunately, most recently, in early June, one of its high-risk drugs failed a Phase II clinical trial. Biogen’s opicinumab (anti-LINGO-1), which is an investigational, fully human monoclonal antibody that was developed to actually repair the nerve damage caused by MS, failed to hit the primary endpoint.
The company did say, however, that “evidence of a clinical effect with a complex, unexpected dose-response was observed,” although details about that response wasn’t disclosed.
The company’s plunged on that news. On June 6, shares traded for $289.84. On June 7, they dropped to $252.58, losing almost $8 billion in market value. Shares are currently trading for $251.51.
In addition to returning BIIB068 to the clinic, Biogen also has BIIB059, an anti-BDCA2 antibody in Phase I, and Dapirolizumab pegol (anti-CD40L), also in Phase I for lupus.
