ProKidney (PROK) said Tuesday its investigational therapy rilparencel stabilized kidney function in a group of patients with chronic kidney disease and diabetes who received two injections about three months apart in a phase 2 trial, replicating the dosing regimen of its ongoing phase 3 study.
The company said it observed a 78% improvement in the annual decline in the estimated glomerular filtration rate, or eGFR, slope following the last injection in this group of patients.
A second group of patients were given an exploratory dosing schedule of one injection followed by a second only if kidney function worsened. The company said the annual decline in eFGR slope improved by 50%, which was not statistically significant but suggested evidence of a dose response.
No treatment-related serious adverse events were observed, and the therapy was generally well tolerated, ProKidney said.
The company said it will have a Type B meeting with the US Food and Drug Administration this summer to discuss its approach of using eGFR slope as phase 3 trial surrogate endpoint for accelerated approval.
Shares of ProKidney were up more than 80% in recent premarket activity Tuesday.
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