CHK-336 / Novartis - LARVOL DELTA

Characterization of CHK-336, A First-in-Class, Liver-Targeted, Small Molecule Lactate Dehydrogenase Inhibitor for Hyperoxaluria Treatment. (PubMed, J Am Soc Nephrol) - "In conclusion, CHK-336 is a potent, liver-targeted, small molecule LDH inhibitor that suppressed urinary oxalate production in a rat pharmacodynamic model and mouse models of PH1 and PH2."

Journal • Genetic Disorders • Nephrology • Renal Calculi • Renal Disease • LDHA

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CHK-336 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=88 | Terminated | Sponsor: Chinook Therapeutics, Inc. | Trial completion date: Aug 2023 ➔ Apr 2023 | Suspended ➔ Terminated | Trial primary completion date: Aug 2023 ➔ Apr 2023; Sponsor decision

Trial completion date • Trial primary completion date • Trial termination • Obesity

Discovery of CHK-336: A first-in-class, liver-targeted, small molecule lactate dehydrogenase inhibitor for hyperoxaluria treatment (ACS-Fall 2023) - P1 | "The human safety, pharmacokinetic and pharmacodynamic profile of CHK-336 in a healthy volunteer SAD study (NCT05367661) will be described. MAD cohorts are still in progress."

Nephrology • Renal Calculi

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 (ERA-EDTA 2023) - "CHK-336 is a first-in-class, orally administered, liver-targeted LDH inhibitor that was generally well-tolerated following single doses from 15 – 500 mg, with dose proportional increases in AUC exposure. Hepatic oxalate production was robustly reduced by CHK-336, as measured by urinary 13C2-oxalate, thus achieving proof of mechanism in HVs. GLOMERULAR & TUBULO-INTERSTITIAL DISEASES"

Clinical • P1 data • Nephrology • Renal Calculi

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CHK-336 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=104 | Suspended | Sponsor: Chinook Therapeutics, Inc. | Recruiting ➔ Suspended

Trial suspension • Obesity

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CHK-336 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Chinook Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Aug 2023 | Trial primary completion date: Dec 2022 ➔ Aug 2023

Trial completion date • Trial primary completion date • Obesity

Preclinical Efficacy of CHK-336: A First in Class, Liver-Targeted, Small Molecule Inhibitor of Lactate Dehydrogenase for the Treatment of Primary Hyperoxalurias (KIDNEY WEEK 2022) - P1 | "Conclusion By potently blocking LDH, the final step in hepatic oxalate synthesis, along with a liver-targeted tissue distribution profile, CHK-336 is a novel oral small molecule with the potential to treat all types of primary hyperoxaluria and other disorders resulting in increased oxalate production. The human safety, pharmacokinetic and pharmacodynamic profile of CHK-336 are currently under investigation in a healthy volunteer SAD/MAD study (NCT05367661)."

Preclinical • Nephrology • Renal Calculi

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CHK-336 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Chinook Therapeutics, Inc.

New P1 trial