Chinese biotechnology company Atom Bioscience has dosed the first patient in a Phase IIb/III clinical trial of ABP-671 to treat chronic gout, one of the most common types of inflammatory arthritis.
The double-blind, multi-centre, randomised study intends to enrol 580 patients from the US and other nations.
The first part of the study will evaluate the efficacy and safety of the URAT1 inhibitor ABP-671 at different doses and regimens, while the second part will be a confirmatory study for dosing regimens selected from the first part.
Results from Part I are due to be published in the fourth quarter of next year.
According to many national gout treatment guidelines, maintaining serum uric acid (sUA) levels of 5mg/dL to 4mg/dL in gout patients is recommended.
In two Phase II studies of ABP-671, the patients dosed were given 1mg to 12mg of the formulation once a day.
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These two studies showed that by dosing once daily, the efficacy of ABP-671 can be maintained for up to 24 hours.
Atom Bioscience CEO, chairman and founder Dr William Dongfang Shi said: “In terms of safety, ABP-671 is well-tolerated.
“Its adverse events were mostly Grade I (mild and generally not bothersome) and the incidence is comparable to that of the placebo group. No severe adverse events have occurred with ABP-671 at the dose tested.
“A Human Mass Balance study, which evaluates how drugs are absorbed, metabolised and excreted, showed that ABP-671 is mostly excreted in its original form and does not produce any of similar metabolites seen with benzbromarone (a currently marketed drug for gout treatment), which causes severe liver toxicity.”
Earlier this year, Atom Bioscience reported positive data from a Phase II study of ABP-671 for treating chronic gout.
Among patients given 1mg of ABP-671 once a day, 86% reached serum uric acid (sUA) levels of less than 6mg/dL.