Chinook Therapeutics Presents Data from CHK-336 Phase 1 Trial in Healthy Volunteers and New Insights into the Role of Failed Repair in Chronic Kidney Disease at the 60th European Renal Association (ERA) Congress

• CHK-336 was generally well tolerated in healthy volunteers (HV) who received single doses up to 500 mg and multiple doses up to 60 mg for 14 days
  
• Pharmacokinetics (PK) was well characterized with dose-proportional exposures and a half-life that supports once-daily dosing
  
• Successful implementation of a novel ¹³C₂-glycolate tracer established proof-of-mechanism of CHK-336 to block hepatic oxalate production in HVs
  
• One serious adverse event (SAE) of anaphylaxis occurred in a multiple ascending dose HV who received one 125 mg dose CHK-336, resulting in voluntary study pause
  
• Additional research presented on the impact of maladaptive tubular epithelial cells on progression of chronic kidney disease
  

SEATTLE, June 17, 2023 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, announced a free communication presentation on CHK-336 presented today at the 60^th ERA Congress being held virtually and live in Milan, Italy.

“The data presented from the phase 1 study of CHK-336 at this year’s ERA Congress successfully demonstrates hepatic LDH target engagement in healthy volunteers and establishes proof-of-mechanism for CHK-336 to decrease hepatic oxalate production,” said Andrew King, chief scientific officer of Chinook Therapeutics. “As we continue to investigate the SAE observed in the 125 mg MAD cohort and consider next steps, the CHK-336 program will remain paused.”

CHK-336, A First-in-Class Orally Administered LDH Inhibitor: Safety, PK and Target Engagement in a First-in-Human Phase 1 Healthy Volunteer Study

CHK-336 is an oral small molecule LDHA inhibitor with liver-targeted tissue distribution in development for the treatment of patients with primary hyperoxaluria (PH) and other kidney stone disorders driven by endogenous overproduction of oxalate.

The phase 1 single-center trial (see www.clinicaltrials.gov, identifier NCT05367661) was designed to evaluate the safety, tolerability, pharmacokinetic profile of CHK-336 in 104 healthy volunteers in randomized, placebo-controlled, double-blinded, single-ascending dose (SAD) and multiple-ascending dose (MAD) settings. Healthy volunteers in the SAD portion of the study received placebo or a single dose of CHK-336 ranging from 15 mg to 500 mg on day 1. Healthy volunteers in the MAD portion of the study were to receive placebo or multiple doses of CHK-336 ranging from 30 mg to 500 mg given daily for 14 days.