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Biogen scores mid-stage trial win for lupus drug BIIB059

Last approved treatment for Lupus was GSK's Benlysta in 2011


Biogen’s experimental drug for systemic lupus erythematosus (SLE) has hit the mark in a phase 2 trial, adding to optimism that a new FDA-approved therapy for the disease is on the horizon.

BIIB059 hit all its objectives in the LILAC study, including a statistically significant reduction in disease activity in patients with SLE and related condition cutaneous lupus erythematosus (CLE) that sets the programme on course for phase 3 trials and a route to market.

Biogen’s trial win comes shortly after AstraZeneca reported new data from the TULIP 2 phase 3 trial of its lupus candidate anifrolumab in August, resurrecting the prospects for the drug after it flunked the earlier TULIP 1 study last year.

Lupus is a disease in which the immune system attacks normal cells and tissues, causing inflammation and organ damage, particularly affecting the skin and joints and is predominantly seen in women.

It has very few treatment options – the last treatment to be approved by the FDA was GlaxoSmithKline’s Benlysta (belimumab) back in 2011, which ended a 50-year drought in new drugs.

Benlysta quickly became the market-leading drug for lupus with sales of £473m ($575m) last year, almost entirely from the US.

Biogen says that in the LILAC trial, BIIB059 – a monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2) – was compared to placebo in two patient groups who had either CLE or SLE.

Both arms of the trial showed that Biogen’s drug achieved a reduction in disease activity compared to control.

A dose response in the CLE arm reinforced the hypothesis that the improvements were attributable to BIIB059, with all three tested – 50mg, 150mg or 450mg – doing better than placebo on the CLE Disease Area and Severity Index Activity (CLASI-A) score at 16 weeks.

The SLE arm only tested the highest 450mg dose of BIIB059, and showed the drug reduced the number of joints with active inflammation compared to placebo at 24 weeks.

The new study is a boost for Biogen and an endorsement of its recent diversification into immunological disease R&D, as investors in the company nervously await the presentation of data from its recently-resuscitated Alzheimer’s therapy aducanumab, which is due to be presented at the Clinical Trials on Alzheimer's Disease meeting in San Diego tomorrow.

“There is substantial unmet medical need for people with lupus given the limited number of treatment options available to help manage this difficult-to-treat and chronic disease,” said Nathalie Franchimont, who heads up Biogen’s lupus and multiple sclerosis business.

“We are excited by the LILAC study results, and the potential for BIIB059 to be a meaningful new treatment option for patients living with lupus,” she added.

Article by
Phil Taylor

4th December 2019

From: Research



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