In March 2018, BIOCAD analyzed results from its Phase II study in which the original Russian IL-17 inhibitor proved highly effective in long-term therapy in patients with severe psoriasis. The drug also showed great results in the treatment of ankylosing spondylitis.
BCD-085 is an original monoclonal antibody drug blocking interleukin-17, a cytokine playing a key role in developing and maintaining various autoimmune and immunoinflammatory diseases.
The worldwide prevalence of psoriasis and ankylosing spondylitis is high – about 4% of the world population. The majority of psoriasis patients have serious psychological problems due to social isolation, while patients with ankylosing spondylitis may rapidly become disabled if diagnosed late or treated inappropriately. Both diseases are a serious medical and social challenge, especially because they often affect young people of working age (22 to 35 years old). The European market of IL-17 inhibitors is over 700 million $ and it’s going to grow to 1 677 million $ within next 5 years. BIOCAD expects to occupy an essential share of this perspective market.
BCD-085 has demonstrated extremely high efficacy in the recently completed Phase II clinical study. Over the first three months of treatment with Interleukin-17 inhibitor at a dose of 120 mg, significant clinical response (PASI 75) was achieved in 93% of patients with moderate to severe psoriasis who did not respond to conventional treatments. Similar improvements were seen in patients with ankylosing spondylitis who were treated with IL-17 inhibitor 120 mg: 91% of patients demonstrated clinical improvements (ASAS20) after 4 months of treatment.
Оne-year treatment with this IL-17 inhibitor resulted in a sustained improvement in psoriasis symptoms (PASI 75) in 98% of cases, with over 50% of patients having an sPGA score of 0 or 1 at the end of the observation, which refers to almost complete skin clearance. High efficacy of BCD-085comes along with a favorable safety profile:
‘IL-17 inhibitor is a rare example of a monoclonal antibody used for the treatment of chronic diseases that has such a beneficial efficacy and safety profile,’ says Roman Ivanov, M.D., PhD, BIOCAD’s Vice-President of Research and Development. ‘We have a good reason to believe that BCD-085will become the best-in-class interleukin-17 inhibitor. This is why we are going to initiate a phase III study in the European Union in 2019; in this study, we will compare our product head-to-head with another IL-17 inhibitor. We hope that patients and physicians from different countries would evaluate and appreciate our product in the near future