Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. It also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization.
The common pathological pathway in progressive chronic kidney disease (CKD) is tissue fibrosis and chemokine receptor type 4 (CXCR4) plays a key role in the development of fibrosis.
Reduction of renal tubular cell polynucleotide phosphorylase (PNPT1) expression has been linked to renal tubular atrophy in chronic kidney disease, according to a new study. The research, published in Nature Communications, found that renal tubular cell PNPT1 reduction causes renal tubular atrophy by inhibiting protein synthesis.
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
Medshine Discovery Inc. has disclosed alkyl carboxylic acid compounds acting as soluble guanylate cyclase (sGC) activators reported to be useful for the treatment of chronic kidney disease.
Researchers from Anhui Medical University published data from a study that aimed to assess the antifibrotic effects of the transforming growth factor-β (TGF-β) receptor type I (TGFBR1/ALK5) inhibitor Cpd-0225.
With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease (CKD).
Ardelyx Inc. could have a rocky row to hoe when it makes its case for tenapanor, as a hyperphosphatemia therapy in adults with chronic kidney disease, before the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The big question facing the adcom is whether the change in baseline serum phosphorous levels achieved by the drug is clinically meaningful. Clearly, FDA reviewers don’t think so, as that question already has resulted in delayed PDUFA dates, a complete response letter and two formal dispute resolution requests.
New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases.
