SUZHOU, China—Innovent Biologics, Inc. has announced that the clinical trial results of IBI303, an anti-tumor necrosis factor-alpha (anti-TNFα) monoclonal antibody injection developed by Innovent, has been published in The Lancet Rheumatology.
Led by Professor Huji Xu of the School of Medicine at Tsinghua University, the multi-center, randomized, double-blind, parallel-controlled Phase 3 trial compared the efficacy and safety of IBI303 and the originator drug adalimumab (Humira), on ankylosing spondylitis (AS) patients. It is the first large-scale head-to-head Phase 3 clinical trial comparing a biosimilar and adalimumab in AS patients. It’s also the first time a highly-regarded top-tier medical journal has featured the major Phase 3 clinical trial results of a China-developed biosimilar.
Adalimumab has been among the world’s best-selling drugs for several consecutive years, with sales revenue of $19.9 billion in 2018. Adalimumab has been approved for treating rheumatoid arthritis, AS and plaque psoriasis in China.
AS is a chronic inflammatory disease that primarily affects spinal joints and peripheral joints, and in severe cases can cause spinal deformity and ankylosis. Anti-TNFα inhibitors exhibit satisfactory anti-inflammatory activity and effects in preventing disease progression, which represent the most widely used biologics with the extensive clinical trial data for the treatment of AS worldwide.
“Autoimmune diseases such as AS severely impact on patients’ quality of life and pose significant economic burden to the society and the patients. Antibodies targeting TNFα currently play an important role in treating autoimmune diseases such as AS. However, the imported anti-TNFα inhibitor drug is far beyond affordable for most patients in China,” said Xu, a prominent physician scientist in the area of rheumatic diseases and the leading PI of the trial.
“IBI303, a biosimilar to adalimumab, was solely developed by Innovent. The Phase 3 clinical trial proved its equivalence in safety and efficacy to the originator Humira. The IBI303 trial results were recognized and published in The Lancet Rheumatology, which is exciting news for the China Rheumatic community and indicates that Innovent has reached international standard in process development and clinical research of biosimilars,” Xu continued.
Twenty hospitals across China participated in the Phase 3 trial. All enrolled patients received at least four weeks of NSAIDs treatment and were either treatment ineffective, resistant or intolerable. Patients treated with either IBI303 or adalimumab subcutaneous injection of 40 mg/0.8 ml once every two weeks for 22 weeks. The primary endpoint was the ASAS20 response rate at week 24.
Among 438 patients recruited in total, 220 were treated with IBI303, while those in the control group received adalimumab. The initial results concluded ASAS20 response rates of 75% and 72.5% respectively at week 24, indicating clinical equivalency between IBI303 and adalimumab. The secondary endpoints were met, including AS assessment points such as ASAS20 response rate at week 12, ASAS40 response rate at week 24, ASAS partial response rates, ASAS5/6 response rate and BASDAI, etc.
The overall data indicate the comparable effects to the originator drug in terms of disease activity, improvement of physical functions, spinal mobility, tendonitis, overall patient assessment and improvement of the quality of life. The results also showed that IBI303 was well tolerated in patients with safety and immunogenicity comparable to those of adalimumab.
The launch of IBI303 is expected to reduce medical expenditure of patients in China, and enhance the affordability and accessibility of the treatment.
“We are very excited about the publication of IBI303 Phase III clinical trial results in The Lancet Rheumatology, which further validated our clinical results, the drug’s efficacy, safety and Innovent's development capability,” added Michael Yu, founder, chief executive officer and chairman of Innovent. “Professor Xu Huji set a great example manifesting the leading standard of Chinese researchers in the clinical science of the related diseases. Although autoimmune diseases such as AS are not fatal, if not treated in time, they can seriously affect patients’ quality of life. We sincerely hope this high-quality drug could be approved and launched soon so that it can benefit patients and their families,” added Dr. Yu.