How BCD-085 works
BCD-085 targets interleukin-17 (IL-17), a protein that promotes inflammation. IL-17 is a cytokine or small protein that sends signals that recruit immune cells to the site of an infection or injury.
Immune cells are designed to protect the body and help tissues heal. In AS, cytokines are overactive, recruiting too many immune cells to the joints in the spine. This causes inflammation that ultimately damages joints.
BCE-085 binds to IL-17, interrupting the signals that promote inflammation. BIOCAD hopes that interrupting the damaging inflammatory response can improve the symptoms and slow the progression of AS.
BCD-085 in clinical trials
A Phase 1 clinical trial (NCT02380287) explored BCD-085’s pharmacokinetics — or how the body processes the drug — and its safety in healthy volunteers.
Thirty-seven men received a single injection. They were divided into groups, with each group receiving a different dose. A key goal of the study was to determine the safest doses to use in Phase 2 clinical trials. The Phase 1 trial began in March 2015 and was completed by October 2015.
A randomized, placebo-controlled, double-blind Phase 2 trial (NCT02763111) of BCD-085 in men and women with AS began in September 2016. Participants are receiving multiple injections of either 40 mg, 80 mg, or 120 mg of BCD-085 over 12 weeks. The study is evaluating BCD’s safety, effectiveness and pharmacokinetic profile.
The effectiveness yardstick is improvements in participants’ ankylosing spondylitis assessment score (ASAS). This measure of disease activity covers pain, stiffness, and swelling.
Investigators are also assessing adverse events, withdrawal symptoms, and measures of drug concentration. This trial is continuing but is no longer recruiting participants.
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