Biocity Biopharmaceutics Co. Ltd.’s selective endothelin receptor type A antagonist, SC-0062, met the primary endpoint of reducing proteinuria in a phase II chronic kidney disease trial. The candidate showed a clinically meaningful and statistically significant reduction in proteinuria, with a clear dose-response relationship and good safety profile.
Just seven months after in-licensing ocedurenone (KBP-5074) from KBP Biosciences Pte. Ltd. in a $1.3 billion deal, Novo Nordisk A/S halted its late-stage study after ocedurenone failed to significantly control hypertension in chronic kidney disease patients.
Xeltis BV hopes that promising data from clinical trials on the performance of its synthetic vascular access graft implant will transform not only the lives of patients suffering from chronic kidney disease but also the company’s fortunes. “We're outperforming other solutions out there, that's the nice promise not only for the patient and for the families but also for potential strategics that might be interested in the company and play a role in the vascular space,” Eliane Schutte, CEO of Xeltis told BioWorld.
Chronic kidney disease (CKD) during diabetes may manifest several phenotypes, including diabetic nephropathy (DN), nondiabetic renal disease (NDRD) or a mixed form.
After a complete response letter (CRL) from the U.S. FDA in 2022 and approvals in Europe, Japan and Australia, Akebia Therapeutics Inc.’s Vafseo (vadadustat) has finally been approved by the FDA. But the uphill climb still isn’t over for Akebia, as it has more hurdles to clear for the drug.
Metyos SAS has raised €2.3 million (US$2.7 million) in pre-seed funding for its biowearable sensor technology which monitors patients with chronic kidney disease (CKD). The funds will be used to progress the technology through clinical trials ahead of FDA approval.
Guard Therapeutics AB has presented progress within the company’s preclinical development platform, the GTX platform, aimed at developing new peptides based on the endogenous protein α-1-microglobulin.
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
