Bayer's sGC Agonist BAY 3283142 Receives IND Approval in China for Chronic Kidney Disease

Jan 17, 2024 16:56 CST Updated 16:56

Bayer

Pharmaceutical Product R&D Developer

▎Edited by the WuXi AppTec content team

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,BayerBayer's Class 1 new drug, BAY 3283142 Hydrochloride Tablets, has received implied clinical trial approval in China and is proposed for development to treatChronic Kidney Disease. According to publicly available information, this is aSoluble Guanylate Cyclase（sGC）Agonist,Bayer has previously completed three Phase 1 studies on this drug.

Screenshot source: CDE official website

Chronic Kidney Disease (CKD) is a condition characterized by the gradual loss of kidney function, where the kidneys are unable to effectively remove waste and excess fluid from the blood. CKD typically progresses gradually, marked by a decline in estimated glomerular filtration rate (eGFR) and elevated albuminuria.Hypertension also makes CKD more likely to worsen.Due to the insidious onset of CKD, the rates of early diagnosis and treatment are low. Once CKD patients progress to end-stage kidney disease (ESKD), they require renal replacement therapy (including hemodialysis, peritoneal dialysis, or kidney transplantation) to sustain life, significantly impacting their quality of life.

sGC is an important component in the nitric oxide (NO) signaling pathway.TheEnzyme,Important for the function of blood vessels and the heartWhen NO binds to sGC, the enzyme catalyzes the synthesis of cyclic guanosine monophosphate (cGMP) within the cell. cGMP is a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling, and is also considered beneficial for chronic kidney disease.

The drug recently approved for clinical trials in China by Bayer issGC Agonist,Proposed Development for the Treatment of Chronic Kidney Disease。According to BayerPublic information,The mechanism of action of BAY 3283142 isActivation of sGC produces cGMP, which relaxes blood vessels, thereby benefiting chronic kidney disease.。

According toClinicalTrialsOfficial website, Bayer has already targetedBAY 3283142 has conducted three Phase 1 clinical trials,Evaluate the safety, pharmacokinetics, etc. of this product, as well as its impact on participants with reduced renal function and mild to moderate hypertension.。

Previously, the sGC agonist jointly developed by Bayer and Merck (MSD)Vericiguat (vericiguat) was approved in the United States in 2021Approved for Marketing. According to an earlier FDA press release, this is alsoThe First sGC Agonist for the Treatment of Patients with Worsening Chronic Heart Failure. In addition, according to official information from Bayer, there is also an sGC stimulant, runcaciguat, in the company's R&D pipeline.（BAY 1101042）, which is currently in the Phase 2 clinical stage for the treatment of non-proliferative diabetic retinopathy (NPDR).

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration. Retrieved Jan 13, 2024, fromhttps://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] ClinicalTrials.gov. Retrieved Jan 13 , 2024. from https://classic.clinicaltrials.gov/

[3]U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure. Retrieved Jan 20 , 2021. from https://www.bayer.com/media/en-us/us-fda-approves-vericiguat-for-patients-with-symptomatic-chronic-heart-failure/

[4]https://www.bayer.com/sites/default/files/ph-rd-pipeline-2023-12-final.pdf. Retrieved Dec 19 , 2023. from https://www.bayer.com/sites/default/files/ph-rd-pipeline-2023-12-final.pdf

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