临床II期糖尿病肾病,智康弘义 z-bio 2024-12-19 882

　　On December 18, 2024, Zhikang Hongyi announced the highly selective endothelin receptor A (ETA) small molecule antagonist SC0062 project, one of its core pipelines. In a 2-SUCCEED clinical phase II trial for chronic kidney disease (CKD) with proteinuria, the results of its diabetes nephropathy (DKD) cohort study reached the main clinical endpoint of 12 weeks - this is another major milestone in the clinical development of SC0062 after the previously announced IgA nephropathy cohort study results reached various clinical endpoints.

　　The experimental results indicate that:

　　In terms of effectiveness, compared with the placebo group, the high-dose group (20mg) of SC0062 can significantly reduce albuminuria, and the results have clinical and statistical significance;

　　Safety: SC0062 showed good safety. Compared with the placebo group, there was no increased risk of water and sodium retention. In this clinical trial, the vast majority of DKD subjects received SGLT2 inhibitors and RAAS inhibitors as basic treatment, while SC0062 was used alone and in combination, demonstrating good safety in the study.

　　These latest results, including more data from 24 weeks, will be announced at an international medical academic conference.

　　2-SUCCEED is a multicenter, randomized, double-blind, placebo controlled, dose exploration, 2-cohort (IgA nephropathy cohort and diabetes nephropathy cohort) phase II clinical trial designed to evaluate the efficacy and safety of SC0062 capsule in chronic kidney disease patients with proteinuria.

　　Previously, SC0062 had reached all clinical endpoints in IgA nephropathy trials. Based on its outstanding clinical manifestations, SC0062 has been included in the breakthrough treatment list by CDE for the treatment of IgA nephropathy with proteinuria.

　　This SC0062 reached the main clinical end point in the diabetes nephropathy test, further indicating that it has a significant and continuous effect of reducing proteinuria in a variety of chronic kidney diseases (CKD) with proteinuria, as well as outstanding safety advantages, which once again proves the potential of its best in class (BIC) molecule.

　　Professor Hiddo Lambers Heerspink, a member of the Zhikang Hongyi Clinical Science Advisory Committee, an internationally authoritative clinical expert in chronic kidney disease, and a professor at the University Medical Center Groningen in the Netherlands
After reviewing the above research results, it is stated that:

　　It's nice to know that SC0062 has achieved positive results in the diabetes nephropathy trial queue, especially that no risk of water and sodium retention caused by SC0062 was found in the study, which will be a major breakthrough in drug development of ETA antagonists.

　　Co founder of Zhikang Hongyi
Dr. Wang Yiyi, the CEO, stated:

　　SC0062 is a new ETA antagonist molecule developed by Zhikang Hongyi, which has demonstrated numerous efficacy and safety advantages in preclinical and early clinical trials.

　　We are pleased to witness the superior effect of SC0062 on reducing proteinuria in patients with diabetes nephropathy. The safety of SC0062 molecule in patients with diabetes nephropathy has greatly enhanced the confidence of SC0062 in developing chronic kidney disease (CKD). At present, Zhikang Hongyi is making every effort to promote the registration of clinical trials in the field of SC0062 kidney disease, in order to benefit the global population of chronic kidney disease as soon as possible.

　　Based on the potential huge clinical advantages and market prospects, the company has launched a phase III clinical study called "SUCCESS-1" for IgA nephropathy, as well as an international multicenter phase III clinical study called "SUCCESS-2" for chronic kidney disease (CKD). The company will continue to fully utilize its excellent clinical development capabilities and work together with top researchers around the world to promote the global clinical progress of this potential best in class molecule, benefiting patients worldwide as soon as possible.

　　Regarding SC0062

　　SC0062 is one of the top three endothelin receptor A (ETA) small molecule antagonists for the treatment of chronic kidney disease that have entered clinical trials worldwide. It is a highly promising Best in Class drug. SC0062 has undergone a novel molecular design for chronic kidney disease, with unique ETA high selectivity, aiming to further enhance drug safety while ensuring efficacy.

　　Preclinical studies have shown that SC0062 has good activity and can effectively improve pathological scores in acute kidney injury and chronic kidney disease models. In the completed clinical phase I study, SC0062 showed good safety, tolerance and pharmacokinetics characteristics, and no side effects such as water and sodium retention were found.

　　SC0062 is currently carrying out a phase II clinical study (2-SUCCEED) on chronic kidney disease with proteinuria. This study is a multicenter, randomized, double-blind, placebo controlled, dose range exploration, and 2-cohort (IgA nephropathy cohort and diabetes nephropathy cohort) clinical study designed to evaluate the effectiveness and safety of SC0062 capsule in chronic kidney disease patients with proteinuria. Professor Chen Jianghua, director of the Kidney Disease Center of the First Affiliated Hospital of Zhejiang University Medical College and former chairman of the Renal Branch of the Chinese Medical Association, served as the main investigator, and has been carried out simultaneously in more than 40 clinical institutions nationwide.

　　The 2-SUCCEED study has completed the enrollment of all subjects in two cohorts. The IgA nephropathy trial has reached the clinical primary endpoint at 12 weeks and the secondary endpoint at 24 weeks. Some of the research results have been published in the top nephrology journal JASN. Another queue of DKD trials has reached the 12 week clinical primary endpoint, and 24 week data is currently being collected and organized, with data analysis expected to be completed in the near future.

　　SC0062 has currently initiated two Phase III clinical studies, one for IgA nephropathy (named "SUCCESS-1") and the other for chronic kidney disease (named "SUCCESS-2").