Phase II Fail Ends Swiss-US Drug for Rare Kidney Disease

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An initially promising drug has failed to show benefits in a phase II trial for the rare kidney disease focal segmental glomerulosclerosis (FSGS), prompting the US biotech ChemoCentryx and its Swiss collaborator Vifor Pharma to drop it for this indication.

Topline results from the phase II trial showed that 12 weeks of treatment with the drug candidate did not decrease urine protein levels significantly more than placebo in 46 patients with the disease. Normally, healthy kidneys let very little protein pass through; higher protein levels indicate there is kidney scarring and damage caused by this condition.

The company will now terminate development of the late-stage oral compound for FSGS. There are few approved treatments for the disease, including steroids and diuretics, and the condition can be resistant to steroids and prone to relapse.

In a 2014 phase II trial, the candidate drug had shown significant benefits for patients with diabetic nephropathy, a kidney condition common among type 2 diabetes patients. 

ChemoCentryx extended an existing collaboration with Swiss pharma company Vifor Pharma in 2016 to include the development and commercialization of this same drug. According to the terms of the deal, ChemoCentryx and Vifor Pharma would jointly develop the drug for the treatment of FSGS, while Vifor Pharma would have the sole rights to developing the candidate for more prevalent kidney diseases such as diabetic nephropathy. So far, Vifor Pharma doesn’t seem to have exercised its rights on the more common indications. 

While the failure of this phase II trial may be a setback, the partners have a more advanced drug in development: Chemocentryx’s lead drug candidate avacopan, for the treatment of inflammatory and autoimmune diseases. They expect to file for FDA approval by mid-2020 for a rare inflammatory condition, with results from two additional trials expected by the end of the year.

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