The phase II clinical trial of XinKangHe Biopharmaceutical's IL-17A/F antibody drug for the treatment of ankylosing spondylitis has achieved its primary research endpoint.

On January 6, 2023, in Beijing, China, and Suzhou, Jiangsu, the domestically innovative IL-17A/F antibody drug XKH004 developed by Xinkanghe Biopharmaceutical completed the treatment of ankylosing spondylitis (AS).Phase IIclinical research conducted the first analysis, successfully achieving the primary clinical research endpoint of the trial. AS is a chronic progressive inflammatory disease primarily affecting the spine, often involving the sacroiliac joints, leading to spinal stiffness and fibrosis. AS mainly affects young people, resulting in impaired quality of life and disability. There are approximately 4 million patients in China alone, and effective treatment options are currently lacking.

Recently completedPhase IIPhase II study (CTR20212135) is a multicenter, randomized, double-blind, placebo-controlledPhase IIclinical trial aimed at evaluating the preliminary efficacy of XKH004 in treating active ankylosing spondylitis (AS), as well as the relationship between dosage and efficacy, with a total of 140 AS subjects enrolled in the study.

The study results show:

In terms of efficacy, among the 123 evaluable subjects, the ASAS40 response rate in the XKH004 treatment group was higher than that in the placebo group (51.4% vs 25%), demonstrating the therapeutic advantage of XKH004 in subjects with active moderate AS.

In terms of safety, the overall tolerability was good, with most patients experiencing TEAEs classified asGrade I-Phase II, with the most common TEAEs being hyperuricemia (10.4%), injection site reactions (9.4%), hyperlipidemia (7.5%), and hypertriglyceridemia (5.7%). This indicates that XKH004 has good safety and tolerability in treating subjects with active moderate AS.

XKH004It has shown good safety and tolerability in patients with active moderate AS, along with very encouraging efficacy advantages, indicating its potential to become the optimal drug for treating AS.

Professor Xu Huji, the head of this clinical study from Shanghai Changzheng Hospital, stated: "Ankylosing spondylitis is one of the stubborn diseases faced by rheumatology and immunology. In recent years, global research into the mechanisms of this disease has deepened, achieving significant progress, including studies on the Th17 pathway. Xinkanghe's XKH004, as an IL17A/F inhibitor, holds great promise to become another safe and effective treatment for ankylosing spondylitis. I am very honored to participate in the clinical research of this globally innovative drug with independent intellectual property rights from China, and I look forward to the drug being launched soon to benefit patients."

You Jianguo, Vice President of Clinical Development at Xinkanghe, stated: "This is the firstPhase IIPhase II clinical trial conducted by the company, led by Leading PI Professor Xu Huji, with strong support from the research teams of 15 research centers, overcoming significant challenges posed by factors including the COVID-19 pandemic, completing the enrollment to primary endpoint analysis in just one year, fully demonstrating the company's clinical development and operational capabilities, and giving us confidence in the successful conduct of the upcomingPhase IIIclinical trial."

About XKH004

XKH004 is a recombinant humanized IgG1 monoclonal antibody targeting human IL-17A/F, jointly developed by Xinkanghe Biopharmaceutical and Lizhu Monoclonal Antibody. XKH004 can simultaneously target the homodimer IL-17A-A and IL-17F-F, as well as the heterodimer IL-17A-F. XKH004 is used for moderate to severe plaque psoriasis, ankylosing spondylitis, and other autoimmune-related indications by blocking the interaction of IL-17A and IL-17F with their downstream pathway receptors, showing potential as a best-in-class drug.

About Xinkanghe Biopharmaceutical

Xinkanghe Biopharmaceutical was established in 2015, founded by Academician Dong Chen, a renowned immunologist, who is the director of the Shanghai Institute of Immunotherapy Innovation and a professor at Shanghai Jiao Tong University School of Medicine and Tsinghua University School of Medicine. The company is committed to developing innovative drugs with independent intellectual property rights, focusing on the development of macromolecular drugs in the fields of autoimmune diseases and immuno-oncology, aiming to provide globally innovative or best-in-class treatment solutions for patients.