China-based Jiangxi Jemincare Group has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its oral drug JMKX003142 in polycystic nephropathy. This marks a significant step forward in the development of a potential new treatment for this chronic kidney condition.
Disease Background and Unmet Needs
Autosomal dominant polycystic kidney disease (ADPKD) is a common genetic disorder often found in young and middle-aged individuals, with an incidence rate of about 1 in 400 to 1 in 1,000. It is estimated that there are 12.5 million patients worldwide, including 1.5 million in China. Due to the lack of targeted therapeutic drugs, approximately 40% to 50% of cases will progress to end-stage renal disease, highlighting the significant unmet need for effective treatments.
Therapeutic Profile of JMKX003142
JMKX003142 is the first of its kind in China and has the potential to become a best-in-class drug for ADPKD. Preclinical animal efficacy studies and safety evaluations have shown that JMKX003142 can inhibit the proliferation of LLC-PK1 cells in a dose-dependent manner and suppress the expansion of human ADPKD renal vesicle cells. Importantly, JMKX003142 avoids the side effects associated with other drugs due to the hook effect, where high concentrations can promote proliferation instead. The drug is expected to enter clinical trials at multiple sites.
Future Outlook
The approval for the clinical study of JMKX003142 underscores Jiangxi Jemincare Group’s commitment to advancing innovative treatments for polycystic nephropathy. With its demonstrated preclinical efficacy and safety profile, JMKX003142 is poised to address significant unmet needs in this area. Jemincare’s ongoing efforts in clinical development highlight its dedication to improving patient outcomes in nephrology.-Fineline Info & Tech
