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China's antibody drug pioneer Sansheng Guojian announced that its recombinant anti-IL-17A humanized monoclonal antibody (drug code: 608) is currently conducting clinical research on the treatment of moderate to severe plaque psoriasis, namely "recombinant anti-IL- The safety tolerability, pharmacokinetics and efficacy of 17A humanized monoclonal antibody injection subcutaneously in the treatment of Chinese patients with moderate to severe plaque psoriasis in randomized, double-blind, placebo-controlled, multi-dose escalation and dose exploration Phase II clinical trial", and the enrollment of the first subject has been completed recently
.
In the completed phase I clinical trial of healthy adult volunteers with a single dose and escalating dose, 608 showed good tolerability and safety
Psoriasis is an immune-mediated polygenetic hereditary skin disease.
Because of its recurring attacks, it is difficult to cure.
It is commonly known as "psoriasis
.
" The onset of psoriasis is mainly mediated by abnormal cellular immunity, and chronic inflammatory proliferation of skin tissue occurs
With the introduction of biologics, although the efficacy of psoriasis treatment has improved to a certain extent, overall, patients with psoriasis are usually less satisfied with treatment, and only 25% are completely satisfied
.
The development of new target drugs has become a hot spot in the treatment of psoriasis at home and abroad, in order to obtain more specific binding to the target, better clinical response rate, tolerability, and long-term efficacy maintenance
608 is the same drug with the same target as Novartis Secukinumab (Cosentyx) and Eli Lilly's Ixekizumab (Taltz), but it is a brand-new amino acid sequence.
It shows the same target antibody Cosentyx and Taltz in in vitro and in vivo animal models.
Equivalent biological activity: It can significantly improve the symptoms of psoriasis models induced by imiquimod in human IL-17 transgenic mice, and its therapeutic effect is equivalent to that of secukimod; in monkey arthritis models, it is clinically similar to Ixekizumab.
The therapeutic effect was similar on multiple indicators such as score, Proximal Interphalangeal Point (PIP) swelling, and incidence of PIP joint
.
Dr.
Jing Lou, Chairman of Sansheng Guojian, said: “Sansheng Guojian has been working in the field of therapeutic antibody drug research and development for nearly 20 years
.
This 608 completed the first phase II clinical trial enrollment, which is our role in autoimmunity.
