Biogen sneaks previously unknown lupus drug into the clinic

Biogen HQ

Analysts at Jefferies have found that Biogen ($BIIB) has quietly sneaked a lupus candidate into the lab for initial testing, coming as it does after the Big Biotech has in recent months cut its lupus research programs.

Last year Biogen axed 830 jobs and pruned its pipeline as it looked to focus on its core assets and save money--a decision that also saw it cut a Phase II lupus program targeting the TWEAK immune cell.

But in a note to clients posted today, Jefferies said that the company has now put forward a Bruton’s tyrosine kinase (Btk) inhibitor, known as BIIB068, into the clinic.

According to, the experimental candidate is targeting systemic lupus erythematosus (SLE) in a Phase I trial of 52 patients, which is expected to enroll by December.

Jefferies noted that while lupus “remains a challenging condition,” some Btk inhibitors have shown “signals of promise” in early trials.

This includes the Btk inhibitor RN486, which in a preclinical trial partly funded by Roche ($RHHBY) managed to stop progression of SLE for 8 weeks, as determined by histologic and functional analyses of glomerulonephritis.

A Btk inhibitor is already on the market in the form of Janssen’s ($JNJ) Imbruvica (ibrutinib), although this is licensed for blood cancers and not lupus. The Bkt mechanism impacts the signaling pathway of antigen receptors on B cells and through preventing B-cell maturation that drives disease progression.

Jefferies said: “Although lupus falls outside of Biogen’s stated core neuro/pain focus, it does fit with the rheumatologic/inflammatory space in which the company has devoted some attention and resources and it appears that they are looking to remain active in lupus specifically.”

Several other programs in lupus are also underway from the Big Biotech: BIIB059, an anti-BDCA2 antibody in Phase I, and UCB lead dapirolizumab pegol, an anti-CD40 ligand currently in early-stage trials that is expected to move into midstage by year’s end.

SLE is a difficult-to-treat disease with a number of variations and subpopulations of patients, but one littered with late-stage failures.

A few years ago GlaxoSmithKline ($GSK) became the first drugmaker in more than half a century to gain approval for a new treatment for the disease in the form of Benlysta.

The drug, a human monoclonal antibody that selectively targets B-lymphocyte stimulator, has however struggled to make much of a sales impact for the company since its FDA approval in 2011.

Benlysta has a license for patients with active, autoantibody‑positive SLE who are receiving standard therapy--but brought home just £230 million ($338 million) in 2015.

This is as a result of its modest efficacy, slow onset of action and restrictive label--which does not include patients with severe, active renal and CNS disease. The drugmaker is however currently undertaking new trials aimed at getting the drug to be used as a subcutaneous formulation.

Other candidates are also in the mix, including UCB’s epratuzumab--although this failed two Phase III trials last year after missing its primary endpoints. And Eli Lilly’s ($LLY) tabalumab was axed in 2014 after it too failed several pivotal late-stage studies.

Anthera Pharmaceuticals’ blisibimod, which focuses on anti-BAFF activity in LSE, is still going in mid- to late-stage studies. And in May, a new startup biotech called Thunderbolt was launched as the brainchild of Baxalta, the Mayo Clinic and Velocity Pharmaceutical Development, with a focus on SLE, also via an anti-BAFF mechanism.

Some more color on this new trial, as well as other R&D updates from Biogen, should be provided during its Q2 next week.

- get the study announcement

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