Taking Onconic Therapeutics' (476060.KQ) gastroesophageal reflux disease drug Jaqbo alongside the cholesterol-lowering drug atorvastatin produces no clinically meaningful change in atorvastatin's blood concentration, according to a new study. The findings provide clinical evidence to support prescribing the two drugs together.
Onconic Therapeutics said on the 21st that results of the clinical study evaluating the interaction between the two drugs were published in the international journal Drug Design, Development and Therapy.
Jaqbo is a novel drug in the potassium-competitive acid blocker (P-CAB) class, while atorvastatin is widely used to lower blood cholesterol levels. Because both drugs are metabolized through liver enzymes in the CYP3A family, researchers needed to determine whether taking them together affects drug concentrations in the body.
A research team led by Professor Shin Won-seok of the Department of Clinical Pharmacology at CHA Bundang Medical Center, CHA University, conducted the drug interaction study in 24 healthy Korean adults. The team administered 40 milligrams of atorvastatin and 20 milligrams of Jaqbo either alone or together, then compared blood drug concentrations. Each dosing period lasted five days, with one dose per day.
When the drugs were taken together, atorvastatin's peak blood concentration was 98% of the level seen with the drug alone, and total exposure — a measure of how much the body is exposed to a drug over a set period — was 103%. The researchers said the results suggest no dose adjustment of atorvastatin is needed under the study conditions. Jaqbo's total exposure was also similar to that seen when taken alone. Adverse events after dosing were mostly mild and all resolved. There were no serious adverse events and no participants dropped out of the study after discontinuing treatment.
An Onconic Therapeutics official said many patients with gastroesophageal reflux disease take multiple medications for chronic conditions such as high cholesterol. The official said the study is significant in providing pharmacokinetic evidence that clinicians can refer to when the two drugs are prescribed together.