ProKidney spikes after mid-stage trial data for lead asset

Shares of ProKidney (NASDAQ:PROK) climbed ~56% in the premarket on Tuesday after the cell therapy developer announced positive topline results from a mid-stage trial for its lead candidate, rilparencel, in patients with chronic kidney disease and diabetes.

Citing its Phase 2 REGEN-007 trial, the Winston-Salem, North Carolina-based biotech said that rilparencel led to a statistically significant and clinically meaningful decline in the slope of the estimated glomerular filtration rate (eGFR), which related to the study’s primary endpoint.

The analysis was based on the Group 1 cohort of REGEN-007, in which patients were randomized to receive two rilparencel injections. The 53-patient trial was designed to evaluate the difference in the annual eGFR slope between the pre-injection period and the period following the last rilparencel injection.

As for tolerability, there were no treatment-related serious adverse events in patients who received at least a single rilparencel dose and the safety profile of the experimental therapy was in line with prior study findings, PROK added.

Additionally, the company noted that the readout boosts its confidence in the design of its Phase 3 PROACT 1 trial, as the dosing regimen used in REGEN-007's Group 1 is similar to the ongoing study, which targets patients with advanced CKD and type 2 diabetes.

The company is awaiting a Type B meeting with the FDA to confirm the viability of using eGFR slope as a surrogate endpoint in PROACT 1 which can support a potential accelerated approval for rilparencel.