Biogen Inc (NASDAQ:BIIB) has quietly brought back a lupus candidate into the clinic for initial testing, this according to analysts at Jefferies. In a note to clients, Jefferies pointed out that the drugmaker had put forward a Bruton’s Tyrosine Kinase (Btk) inhibitor, known as BIIBO68, into the clinic. This move comes at a time when Biogen has cut its lupus research program by axing 830 jobs and pruned its pipeline with the aim of focusing on its core assets to save money.
According to clinacaltrials.gov, the experimental drug is targeting systemic lupus erythematosus (SLE) in a Phase I trial of 52 patients, which is expected to start in December. Jefferies pointed out that while lupus is still a challenging condition, Btk inhibitors have shown promising signals in early trials. The inhibitor managed to stop the progress of SLE for eight weeks, as determined by histologic and functional analyses of glomerulonephritis.
Currently, there is already a Btk inhibitor in the market in the form of Imbruvica (ibrutinib), though it is licensed for blood cancer and not lupus. Treating SLE is difficult due to a number of variations in subpopulations of patients. A few years ago, GlaxoSmithKline plc (NYSE:GSK) 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.
There are several lupus programs for big pharma including an anti-CD40 ligand currently in early-stage trials, and UCB lead dapirolizumab pegol.
Lupus does not fall in Biogen’s core neuro/pain focus, but it fits with the inflammatory space in which the company has devoted attention and resources.