The Russian biotech company Biocad has finished recruiting patients for a clinical trial of its drug, netakimab. The manufacturer’s press service told GxP News that the company plans to evaluate the drug’s effectiveness and safety in treating psoriasis in children aged six to 12.
BCD-085-16/ PLANETA-KIDS Clinical Trial has been launched in research centers in Moscow, St. Petersburg, Kazan, Nizhny Novgorod, Yekaterinburg, Kemerovo, Novosibirsk, Chelyabinsk, Kirov, Krasnodar, Barnaul, Ryazan, Rostov-on-Don, and Saratov.
“The successful experience of prescribing the drug in real clinical practice allowed the company to initiate a clinical trial in the pediatric population. This is especially important since over 30% of psoriasis patients are diagnosed before the age of 20,” said Yulia Linkova, Biocad’s Vice President for Clinical Development and Research.
The study previously included children between the ages of 12 and 17 who continue to participate. An interim assessment of therapy safety showed that netakimab is well tolerated by patients under the age of 18. Additional animal studies also confirmed the drug’s favorable safety profile. Based on the results obtained, the recruitment of patients over 6 years of age was approved.
Netakimab was registered in Russia in 2019 for the treatment of moderate to severe psoriasis vulgaris. It became available for patients by prescription in July of the same year and has been included in the list of vital and essential drugs since 2020. In 2020, the indications for the use of netakimab were expanded to include active psoriatic arthritis and active ankylosing spondylitis in adult patients.
The drug is a monoclonal antibody that blocks interleukin-17, a pro-inflammatory cytokine which plays a key role in the pathogenesis of psoriasis. Clinical studies involving adult patients have demonstrated the drug’s high efficacy, favorable safety profile, and low immunogenicity.
