Akeso’s Gumokimab poised to redefine Psoriasis treatment

Akeso, Inc., a leading biopharmaceutical innovator based in Hong Kong, is making significant strides in the treatment of autoimmune diseases. The company recently announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for gumokimab, an IL-17-targeting monoclonal antibody designed to treat moderate to severe plaque psoriasis.

The acceptance of gumokimab’s NDA underscores Akeso’s dedication to developing cutting-edge therapies that address unmet medical needs. As a groundbreaking treatment targeting a critical pathway in psoriasis, gumokimab holds the potential to deliver rapid relief, long-lasting efficacy, and enhanced safety for patients.

What makes Gumokimab stand out in Psoriasis care?

Gumokimab, also known as AK111, is an innovative monoclonal antibody that inhibits IL-17, a pro-inflammatory cytokine central to the development of plaque psoriasis. Unlike conventional treatments, gumokimab offers a powerful combination of rapid symptom relief and long-term disease stability.

Rapid relief backed by clinical data

In clinical trials, gumokimab demonstrated significant improvements as early as two weeks into treatment. By week 12, approximately 96% of patients achieved a PASI 75 response, with over 40% reaching PASI 100, indicating nearly complete clearance of lesions. These results highlight gumokimab’s ability to quickly alleviate symptoms for patients suffering from moderate to severe psoriasis.

Sustained long-term efficacy

Beyond rapid relief, gumokimab delivers sustained results. Over a 52-week period, gumokimab maintained high efficacy rates, with 100% of patients achieving PASI 75 and nearly 65% achieving PASI 100. This durability ensures that patients experience consistent symptom management and improved quality of life over the long term.

A strong safety profile

Safety and tolerability are critical factors in the management of chronic conditions like psoriasis. Gumokimab has been shown to have a safety profile comparable to a placebo, with fewer adverse events reported. This makes it a viable option for long-term use, addressing a key concern for patients and healthcare providers alike.

Why is the IL-17 pathway a key target for Psoriasis?

The IL-17 cytokine plays a crucial role in the inflammatory processes that drive plaque psoriasis. By targeting and inhibiting this pathway, gumokimab disrupts the cycle of inflammation, reducing lesion severity and preventing disease progression.

Professor Xu Jinhua of Huashan Hospital, Fudan University, who served as the principal investigator for gumokimab’s pivotal registration trial, noted that the drug is uniquely positioned to meet the growing demand for treatments offering rapid onset, long-term stability, and minimal side effects. Xu highlighted gumokimab’s ability to achieve “near-clearance” of lesions while maintaining disease stability over time.

Akeso’s commitment to autoimmune innovation

The approval of gumokimab’s NDA reflects Akeso’s broader strategy of addressing autoimmune diseases with differentiated therapies. Gumokimab is Akeso’s third non-oncology innovative drug to reach the commercialization stage, following ebronucimab (PCSK9) and ebdarokimab (IL-12/IL-23). Together, these therapies form a robust portfolio that addresses a range of patient needs in autoimmune care.

Akeso’s development pipeline also includes treatments for ankylosing spondylitis, another debilitating autoimmune condition. A phase III clinical trial is currently underway to explore gumokimab’s efficacy in managing this disease, further broadening its potential applications.

How does Akeso maintain a competitive edge?

Akeso’s success lies in its comprehensive and integrated research and development platform. The company’s ACE Platform and Tetrabody technology have enabled the development of over 50 innovative assets, with 22 currently in clinical trials.

Dr. Yu Xia, Founder and CEO of Akeso, emphasized the importance of addressing diverse disease pathways to create synergy within the company’s portfolio. “By launching products such as ebronucimab, ebdarokimab, and gumokimab, we aim to meet a wide range of patient needs while enhancing our global competitiveness,” Xia stated. She also highlighted the company’s commitment to affordability and accessibility, ensuring innovative therapies reach patients worldwide.

With a strategic focus on both oncology and non-oncology segments, Akeso is well-positioned to maintain its leadership in biopharmaceutical innovation.

What’s next for Gumokimab?

The acceptance of gumokimab’s NDA brings the drug one step closer to market availability in China. As psoriasis patients face limited treatment options, gumokimab represents a significant advancement in providing effective and safe care.

Looking ahead, Akeso plans to optimize its commercialization strategy to ensure that gumokimab and other non-oncology products reach their full market potential. By leveraging its efficient R&D processes and global partnerships, Akeso is poised to expand its impact in the biopharmaceutical industry.