Metabolex has announced the positive results from its clinical study of Arhalofenate in combination with febuxostat (Uloric), used to treat patients with hyperuricemia and gout.
Arhalofenate is a uricosuric agent which, when used in combination with xanthine oxidase inhibitors, could be a treatment option for patients with tophaceous gout, a chronic, progressive rheumatic disease.
The open label clinical pharmacology study involves a single cohort of 11 gout patients with serum uric acid (sUA) levels of at least 8mg/dL, and were either treatment naive or had discontinued uric acid lowering therapies.
The primary aim of the trial is to assess the percentage of patients reaching goal for the sUA targets of 5mg/dL and 4mg/dL when treated in combination with the highest dose of febuxostat and two doses (400mg and 600mg) of arhalofenate.
In the study, all patients received colchicine throughout for flare prophylaxis, and after the two-week period the patients received febuxostat (80mg) for one week, subsequently, they were given 400mg of arhalofenate for two weeks followed by up-titration of arhalofenate to 600mg for an additional two weeks.
Following two weeks of treatment with 400mg of Arhalofenate, the response rates were increased to 100% and 36%, respectively, and treatment with 600mg of the drug increased the response rates to 100% and 82%, respectively.
Arhalofenate has completed eight Phase 1 and four Phase 2 studies in patients with type 2 diabetes, demonstrating the safety and tolerability of the drug in more than 550 patients for up to six months of treatment.
Metabolex chief medical officer Raymond Urbanski said the study confirms the ability of Arhalofenate to be used with febuxostat to provide clinically and statistically meaningful lowering of serum uric acid for patients with tophaceous gout.
"This combination of oral agents has the potential to lower serum uric acid levels into the range needed to promote dissolution of debilitating uric acid crystals, thereby providing a potential treatment alternative for this patient population," Urbanski added.
The company is also conducting two other Phase 2b studies, the first study will evaluate the safety and sUA lowering activity of Arhalofenate when used as monotherapy, and the second is designed to assess the safety and sUA lowering activity of Arhalofenate in conjugation with the xanthine oxidase inhibitor allopurinol.