Chinook Voluntary Pauses Dosing in Rare Kidney Disease Trial
April 11, 2023
Rare Daily Staff
Chinook Therapeutics said that it temporarily paused dosing in the phase 1 clinical trial of CHK-336, a candidate for the potential treatment of a rare genetic kidney disease, in healthy volunteers.
The pause will allow a thorough investigation of a serious adverse event (SAE) that occurred in a single subject following the first dose in the 125 mg multiple ascending dose (MAD) group. Dosing was halted per trial protocol when the event occurred, followed by a voluntary pausing of the trial by Chinook to enable further investigation. The event has been reported to the U.S. Food and Drug Administration through a Suspected Unexpected Severe Adverse Reaction (SUSAR) report.
The company said the SAE had a rapid onset and rapid recovery and follow-up of the subject is ongoing. Based on evaluation to date with input from expert consultants, the underlying cause of the event is being investigated as a potential hypersensitivity reaction to the study drug or its excipients. Next steps will be determined once Chinook and the trial’s Safety Monitoring Committee have reviewed all safety data. Previously, CHK-336 was generally well tolerated in a total of 62 subjects at single doses up to 500 mg and multiple doses up to 60 mg daily for 14 days.
CHK-336 is an oral small molecule LDHA inhibitor for the treatment of hyperoxalurias, is being evaluated for the treatment of primary hyperoxaluria in a phase 1 clinical trial in healthy volunteers.
Primary hyperoxaluria (PH) is a group of rare genetic metabolic disorders that are characterized by the accumulation of oxalate in the kidneys and other organ systems of the body. Affected individuals lack functional levels of a specific enzyme that normally prevents the accumulation of oxalate. There are three main types of PH – PH types 1, 2, and 3 – differentiated by the specific enzyme that is deficient. In the kidneys, excess oxalate binds with calcium to form calcium oxalate, the main component of kidney and urinary stones. Chronic, recurrent stone formation and the accumulation of calcium oxalate in kidney tissue can cause chronic kidney disease, which can ultimately progress to kidney failure.
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