Netakimab (BCD-085) is a monoclonal antibody that BIOCAD is developing as a treatment for ankylosing spondylitis (AS) and other inflammatory diseases.

How Netakimab works

Netakimab 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.

Netakimab 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.

Netakimab in clinical trials

A Phase 1 clinical trial (NCT02380287) explored netakimab’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) evaluating netakimab’s safety, effectiveness, and pharmacokinetic profile in 89 men and women with AS. Participants received multiple injections of either 40 mg, 80 mg, or 120 mg of netakimab for 12 weeks.

The effectiveness yardstick was improvements in participants’ ankylosing spondylitis assessment score (ASAS). This measure of disease activity covers pain, stiffness, and swelling. Investigators also assessed adverse events, withdrawal symptoms, and measures of drug concentration.

Results showed that netakimab was effective and generally safe in AS patients, which supported the launch of a multicenter, randomized, placebo-controlled Phase 3 clinical trial (NCT03447704). The trial is currently evaluating the safety and effectiveness of netakimab 120 mg against a placebo, for up to one year, in 228 patients with active AS.

 

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