Diamedica Therapeutics Inc.’s chief medical officer, Harry Alcorn, said that “due to the complexity [of diabetic kidney disease (DKD)], there's not a clear answer” as to why such patients did less well in the company’s Redux phase II trial with DM-199 (recombinant human tissue kallikrein 1 [KLK1]). “But I wouldn't say that there wasn't a response in the DKD group,” he said, citing upside in 30% of subjects.
A failure of Tricida Inc.'s most recent efforts to overcome FDA objections to an NDA for the company's sole candidate, veverimer, for treating metabolic acidosis, sent company shares (NASDAQ:TCDA) 30.6% lower to $5.11 on Feb. 26. The complex story appears focused now on the agency's desire for additional and more reliable data to support a potential approval. Tricida President and CEO Gerrit Klaerner on Thursday suggested the ongoing renal outcomes study, Valor-CKD, might provide it.
Shares of Tricida Inc. (NASDAQ:TCDA) fell 47.2% to $4.37 on Oct. 29 after the company said the FDA would require data on how veverimer, its investigational therapy for metabolic acidosis in patients with chronic kidney disease (CKD), impacts CKD progression to support an accelerated approval. The news followed a complete response letter that met the NDA in August.
Akebia Therapeutics Inc. CEO John Butler said “a clear path forward” exists for vadadustat in chronic kidney disease (CKD) despite negative phase III safety findings, and the company plans to file for approval as early as next year in the U.S. and Europe.
As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
Detailed results from a phase III test of Astrazeneca plc's Farxiga found that adding the drug to standard of care in patients with chronic kidney disease reduced a composite measure of worsening of renal function or risk of cardiovascular or renal death by 39% compared to placebo.
In a bid to expand its presence in the cardiometabolic disease space and strengthen its core business in diabetes and obesity, Novo Nordisk A/S is buying Corvidia Therapeutics Inc., of Waltham, Mass., for $2.1 billion, which includes a $725 million up-front payment.
