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Litifilimab, a humanized immunoglobulin G1 monoclonal antibody that targets blood dendritic cell antigen 2, has been granted an FDA Breakthrough Therapy Designation, according to an announcement from the manufacturer, Biogen.
Litifilimab, also known as BIIB059, is a first-in-class therapy used to manage cutaneous lupus erythematosus (CLE), according to the release.
Therapies that show promise in significantly improving life-threatening or altering conditions and that outperform the currently available treatments generally receive this designation from the FDA. This designation is based on data that includes the results of the phase 2 LILAC study that compared different doses of litifilimab with placebo, according to the company.
“This designation for litifilimab is critical to accelerate progress for a condition for which there is no specifically approved treatment,” Albert T. Roy, president and CEO of the Lupus Research Alliance, said in a press release issued by the Alliance. “CLE symptoms affect 70%-85% of people with lupus and can be debilitating,” he added.
The LILAC study evaluated the safety and efficacy of litifilimab in adults with CLE, comparing 450 mg (n = 48), 150 mg (n = 25), and 50 mg doses (n = 26) of litifilimab, administered subcutaneously, to placebo (n = 33). At baseline, the average CLE Disease Area and Severity Index-Activity (CLASI-A) scores were 16.5 for the placebo group, 15.2 for the 50-mg litifilimab cohort, 18.4 for the 150-mg litifilimab cohort, and 16.5 for the 450-mg litifilimab cohort. Results were published in 2022.
At 4 months, compared with placebo, the changes in CLASI-A scores from baseline were as follows:
- -28.0 percentage points (95% CI, -44.6 to -11.4) for those on 450 mg.
- -33.4 percentage points (95% CI, -52.7 to -14.1) for those on 150 mg.
- -24.3 percentage points (95% CI, -43.7 to -4.9) for those on 50 mg.
Litifilimab is currently being evaluated in the phase 3 AMETHYST study. Results are expected to be available in 2027, according to Biogen.
