Completion of Patient Enrollment for Phase II Clinical Trial of IL-17A Monoclonal Antibody AK111 for Treatment of Moderate-to-Severe Plaque Psoriasis

(HONG KONG, 29 Sept 2021) Akeso, Inc. (the Company, 9926.HK) announces that the phase II clinical trial of the Company’s self-developed IL-17A monoclonal antibody AK111 for treatment of moderate-to-severe plaque psoriasis has completed patient enrollment. The Company expects the phase III clinical trial would initiate in early 2022.


Previously, the phase Ib clinical trial of AK111, which involves multiple and repeated dose     to subjects with moderate-to-severe plaque psoriasis, has completed. The clinical trial results have shown that under the circumstance in which the frequency of dosing of AK111 is lower than the drug with the same target, the condition of subjects in each dosage group administered with AK111 have made significant improvement at  12  weeks  and  their Psoriasis Area and Severity Index (PASI) reached  a  high  response  rate,  including  PASI90, PASI100 and Physician Global Assessment (PGA) score 0/1, whereas long-term efficacy of AK111 lasted after discontinuation of the medication for 12 weeks. Meanwhile, AK111 has shown good safety and tolerability in subjects with psoriasis.


Psoriasis is a chronic immune-mediated skin condition and there are approximately 125 million patients globally. IL-17-targeted treatment for autoimmune diseases represents the dawn of a new era, especially the treatment for psoriasis. Since then, the Company has rapidly started clinical trials for the treatment of psoriasis and ankylosing spondylitis, which has shown the Company’s ability in research and development, innovation in the field of innovative drugs as well as its trend-leading position in the field of biotechnology innovation.



About AK111 (IL-17A Monoclonal Antibody)

AK111 is a novel drug targeting IL-17A of autoimmune treatment diseases independently developed by the Company. AK111 is intended to be used for the treatment of psoriasis, ankylosing spondylitis and axial spondylitis. Through combination of competitive blockers, namely IL-17A and IL-17RA, and blocking the biological activities of IL-17, AK111 has reached the efficacy in immune-related diseases in clinical therapies. Currently, the phase II clinical trial of AK111 for treatment of ankylosing spondylitis is rapidly enrolling patients. Cosentyx (secukinumab) and Taltz (ixekizumab), drugs under the same category for such target, have been approved by the Food and Drug Administration of the United States for treating axial spondylitis, of which the global sales of secukinumab amounted to approximately US$3.995 billion in 2020.


About Akeso, Inc.

Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable   to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In Aug 2021, the Company’s first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection (安尼可®) was approved to the market. The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.