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Biogen's Lupus Candidate Meets Endpoint in Phase II Study

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Biogen Inc. (BIIB - Free Report) announced positive top-line data from a phase II study evaluating the safety and efficacy of its fully humanized IgG1 monoclonal antibody (mAb) BIIB059.

The LILAC study, which evaluated BIIB059 in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE), met its primary endpoints by demonstrating statistically significant reduction of disease activity in patients with CLE and SLE, who received BIIB059 compared to placebo.

The two-part LILAC study evaluated BIIB059 versus placebo in patients with active CLE including chronic and subacute subtypes with or without systemic manifestations and in patients with SLE with active joint and skin manifestations.

Per the press release, the CLE part of the study met its primary goal by showing a dose response on the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity score at week 16 on treatment with BIIB059.

The SLE part of the study also met with success of reducing disease activity in people with SLE as measured by change from baseline in total active joint count at week 24 on treatment with BIIB059 compared to placebo.

Notably, the safety and tolerability profile of BIIB059 continues to support its development. Biogen plans to present the detailed results from the study at a scientific forum ahead.

Shares of Biogen have decreased 3.2% so far this year against the industry’s increase of 4.6%.




Per the company, people living with lupus have limited number of treatment options available to manage this difficult-to-treat and chronic disease, which has a substantially unmet medical need.

We remind investors that AstraZeneca (AZN - Free Report) is evaluating its human mAb anifrolumab in a phase III study for treating patients with SLE. Currently, there are very few medicines approved for SLE.

Zacks Rank & Stocks to Consider

Biogen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Anika Therapeutics Inc. (ANIK - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 69.3% so far this year.

Vertex’s earnings estimates have been revised 5% upward for 2019 and 10.6% for 2020 over the past 60 days. The stock has surged 33.4% year to date.

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