First Russian Original Therapeutic Monoclonal Antibody is Registered

| By | Biocad, Russian Pharma

Biotechnology company BIOCAD registered its original interleukin-17 inhibitor (anti-IL-17) for the treatment of moderate to severe plaque psoriasis. Development and clinical studies of the new drug Efleira® (international non-proprietary name: netakimab) have taken 8 years and 500 million rubles of R&D investment. Efleira® is expected to come to the market as early as in May 2019. BIOCAD’s forecasts predict about a 3-fold decrease in the average costs for treatment with IL-17 inhibitors once the new drug is marketed.

Netakimab is a monoclonal antibody blocking interleukin-17, a pro-inflammatory cytokine that plays a key role in the pathogenesis of psoriasis. The biologic was developed on the basis of sequences from lama’s immunoglobulins. The amino acid sequences of lama’s antibodies were replaced with human ones by genetic engineering. Lama’s CDRs (protein regions responsible for binding to the target) remaining in the antibody allow a high affinity of the drug to interleukin-17. Patients with psoriasis often suffer from limitations in their social life, isolation and being discriminated by other people. With its efficacy and short time to response, Efleira® will allow them to live a normal happy life. With their high efficacy in severe psoriasis, several therapeutic monoclonal antibodies are standard of care for psoriasis patients worldwide.

Registration of the first Russian monoclonal antibody demonstrates a high level of science and pharmaceuticals in Russia. Russian companies can not only reproduce foreign technologies but also create our own original drugs with high efficacy and safety,

said a representative of the Ministry of Healthcare of Russia.

We believe that the first Russian original therapeutic monoclonal antibody can become the best IL-17 blocker in its class. It is important to note that netakimab is one of few monoclonal antibodies with a unique favorable safety profile. This is vital for a medicinal product intended for the treatment of a chronic disease,

commented Roman Ivanov,
Vice President R&D, JSC BIOCAD.

The efficacy and safety of Efleira® in patients with psoriasis were confirmed in Phase II and III studies: BCD-085-2 and BCD-085-7 (PLANETA). The Phase III study BCD-085-7/PLANETA was conducted in 22 certified study sites in Russia and 2 study sites in the Republic of Belarus. A total of 213 patients with moderate to severe psoriasis were involved in the study. The total duration of therapy and follow-up in this study is 3 years. Data obtained after 12 weeks of the treatment showed that 83.3 percent of patients who received netakimab once a month after induction for the first 3 weeks achieved a 75-percent improvement in Psoriasis Area and Severity Index (PASI 75); one out of three patients had their skin completely cleared. Treatment with netakimab resulted in a rapid and significant reduction in all major psoriasis signs, including those in patients who have failed to respond to previous systemic therapies. The new drug has a unique favorable safety profile. The importance of netakimab development was emphasized by the Russian Ministry of Healthcare.

According to BIOCAD’s forecasts, the new drug is expected to reduce the treatment costs for severe psoriasis by 25 to 30 percent.

Netakimab will be available for hundreds of thousands of Russian patients as early as in May 2019. I am sure that it will be able to come to international markets in the future. Even during the search for the molecule we conceived this drug as an export one. Efleira® was investigated in a comprehensive clinical program complying with the international regulations. We are preparing to initiate clinical studies of Efleira® in the European Union and China,

said Dmitry Morozov, CEO of BIOCAD.

BIOCAD CEO added that a pivotal clinical trial of netakimab in psoriasis in Europe is to be started as early as in the 4th quarter of 2019.

By various estimates, about 3 million people in Russia have psoriasis. About 50 percent of patients have moderate to severe psoriasis, with severe clinical symptoms (erythema, swelling, exfoliation, itch) and over 10 percent of body surface involved. Psoriasis is often defined as a chronic systemic immune inflammatory disease that includes skin symptoms and systemic disorders, for example, psoriatic arthritis, which can lead to severe disability. Such comorbidities as metabolic syndrome, cardiovascular disorders and depression are more common in patients with psoriasis than in the general population. These factors deteriorate psoriasis patients’ quality of life and reduce their life expectancy.

SOURCE: biocad
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