Chinook Therapeutics has flown a phase 1 trial back to base after a patient experienced a serious adverse event following dosing with the biotech’s potential hyperoxaluria treatment.
The patient in question had received their first 125-mg dose of the drug, dubbed CHK-336, as part of the multiple ascending dose portion of the study. The patient experienced a rapid onset of the event followed by a rapid recovery, leading Chinook to voluntarily pause the study and inform the FDA.
The company is investigating the underlying cause of the event as a potential hypersensitivity reaction to either CHK-336 or its excipients, Chinook said in a release Tuesday morning. The biotech will decide how to proceed once the trial’s safety monitoring committee has reviewed all the safety data.
Up until now, CHK-336 had been generally well tolerated among the 62 participants in the trial of healthy volunteers, who have received single doses up to 500 mg and multiple daily doses of up to 60 mg for 14 days, the company pointed out.
CHK-336 is an oral small molecule lactate dehydrogenase A inhibitor being assessed for the treatment of hyperoxalurias, a group of genetic conditions that can lead to kidney damage and failure. It is the least advanced of the kidney-disease-focused biotech’s clinical pipeline, which is led by atrasentan, a selective endothelin A receptor antagonist in a phase 3 trial for IgA nephropathy and a phase 2 study for glomerular diseases. Its other clinical asset is BION-1301, an anti-APRIL monoclonal antibody in phase 2 development for IgA nephropathy.