Akeso, Inc. announced that the New Drug Application (NDA) for gumokimab (AK111), its internally developed IL-17-targeting monoclonal antibody, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for the treatment of moderate to severe plaque psoriasis.
The strategic combination of gumokimab with other drugs like ebronucimab (PCSK9 inhibitor) aims to address the differentiated treatment needs of psoriasis patients and enhance the company's overall product synergy in the autoimmune disease field.
Clinical Efficacy
Gumokimab has been evaluated in four clinical studies involving patients with moderate to severe plaque psoriasis, including one pivotal Phase III clinical trial (AK111-301) and three supportive studies. The data demonstrated rapid and sustained efficacy.
- Short-term Efficacy: At week 12, the PASI 75 response rate approached 96%, with an sPGA 0/1 response rate nearing 90%. The PASI 90 response rate was close to 80%, and the PASI 100 response rate exceeded 40%, all significantly superior to the placebo group. Over 80% of patients achieved a PASI 90 response, and approximately 50% achieved a PASI 100 response.
- Long-term Efficacy: Gumokimab monotherapy demonstrated sustained efficacy over 52 weeks, with continuous improvement and long-lasting maintenance. By week 52, the PASI 75 response rate approached 100%, with stable sPGA 0/1 response rates. The PASI 90 and PASI 100 response rates further improved to nearly 90% and 65%, respectively.
Safety Profile
During both the placebo-controlled phase and the overall treatment phase, the incidence of adverse events was comparable between the gumokimab and placebo groups, with the gumokimab group showing slightly lower values across all metrics.
Expert Commentary
Professor Xu Jinhua, the principal investigator of the pivotal registration study of gumokimab at Huashan Hospital, Fudan University, noted the increasing demand for psoriasis medications that offer rapid onset, short-term efficacy, long-term stability, and good tolerability. He stated, "Gumokimab, an IL-17A IgG1 monoclonal antibody, directly targets the IL-17RA pathway, a key driver of psoriasis, providing faster and more effective results. Data from four studies demonstrate its potential to better meet patient needs, particularly in achieving near-clearance of lesions and maintaining disease stability. Moreover, the incidence of adverse events with gumokimab is comparable to that of the placebo, indicating good safety and tolerability. We eagerly anticipate the early availability of Gumokimab as a more efficient treatment option for psoriasis patients in China."
Akeso's Strategy
Dr. Yu Xia, Founder, Chairwoman, and CEO of Akeso, expressed excitement about the clinical trial results and the NDA submission. She highlighted that Akeso aims to address the urgent need for better psoriasis treatments with gumokimab and ebdarokimab, which target different disease pathways and complement each other. With the successful launch of products such as ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23) and gumokimab (IL-17), as well as the efficient advancement of innovative non-oncology drugs targeting multiple indications, including manfidokimab (IL-4R), IL-4R/ST2 bispecific antibody, and therapies for neurodegenerative diseases, the vitality and synergy of our product portfolio are growing stronger.
