Usynova Pharmaceuticals Ltd. recently announced that its independent-developed new biological agent UA007 successfully completed the phase I clinical trial of gout. This clinical trial is a single-center, randomized, double-blind, single-dose phase I clinical project designed to further explore the safety and pharmacokinetic profile of UA007 in patients with gouty arthritis. In preliminary clinical trials, UA007 has been shown to have a good safety and tolerability profile in healthy individuals. The results of this clinical trial showed that UA007 was safe and well tolerated in the gout patient population, with no serious adverse events and no significant hepatic or renal toxicities. Pharmacologically, UA007 also showed a good pharmacokinetic profile.

The UA007 gout phase I clinical trial was conducted at the Department of Rheumatology, Zhongshan Hospital Affiliated to Fudan University, led by a renowned rheumatologist Jiang Lindi. From the initiation of the trial to the trial completion of the last subject, the clinical related work of phase I project was completed at a high level of quality in just three months. This can not be achieved without the professional and efficient clinical trial research team led by Director Jiang Lindi.

Director Jiang Lindi expressed her hope that UA007 would perform even better in late-stage clinical trials and the product would be marketed soon to fill the gap of this class of drugs in China. Dr. Zhang Zhuojun, the project investigator, said that the rapid enrollment and active cooperation of the subjects in this trial reflected the expectations of gout patients for the new drug, and hoped that UA007 could successfully complete subsequent clinical trials. Dr. Liu Wenbin, Vice President of Clinical Operations of Usynova, said that refractory gout remained a key and difficult area of clinical treatment, and there was no effective and safe biological agent in China yet. He hoped the marketing of the drug could meet the treatment needs of these patients.

About gout

Gout is a metabolic disease that causes serious harm. It features recurrent attacks, protracted course of disease and refractoriness. The prevalence of gout is increasing worldwide every year. In China, gout has become the "fourth H" disease following hypertension, hyperlipidemia, hyperglycemia, and epidemiological surveys show that about 187 million people suffer from hyperuricemia in China, of whom more than 20 million are gout patients. However, with the prevalence increasing year by year, the treatment of gout still faces pressing issues such as clinical drug selection, side effects of existing drugs and poor patient compliance. To address these unmet clinical needs, Usynova has developed its own new biological agent - UA007.

About UA007

UA007 can effectively inhibit IL-1 signaling pathways and antagonize its induced inflammatory responses. In recent years, with the in-depth understanding of the pathogenesis of gout, IL-1 signaling pathway plays a key role in triggering the onset of acute gout. Based on this, the 2016 EULAR evidence-based recommendations for the management of gout believe that IL-1 signaling pathway inhibitors are an effective method to manage gout attacks, which can be used to treat frequent acute gout, and can be used in patients for whom colchicine, NSAIDs, corticosteroids are contraindicated, intolerable or ineffective. However, IL-1 signaling pathway inhibitors for gout treatment are hardly available in China market so far. Usynova will continue to promote the clinical trial of UA007 and strive for an early launch to fill this gap, so that gout treatment in China can be in line with international standards and benefit the majority of patients.

About Usynova

Established in January 2020, Usynova Pharmaceuticals Ltd. focuses on autoimmune diseases and cancer to address unmet clinical needs and develop Class I new drugs with independent intellectual property rights. It boasts a domestic first-class management team and top R & D strength. The founder and core team members come from multinational pharmaceutical companies and leading domestic CROs and have extensive project experience in the development of small molecule drugs and antibody drugs, especially in the field of oncology and immunology. The company has extensive R&D pipelines with over 10 major products in development, including several First-in-class projects. UA007 has obtained two Chinese clinical approvals for conducting phase II trials in 2022 regarding the prevention and treatment of chemotherapy induced diarrhoea (CID) and acute gout. UA021 is a drug for new targets in autoimmune diseases, and a phase I clinical trial of the drug is expected to be carried out in Australia in the second half of 2022, and drug application both in China and the United States will be conducted.