Biotech company Ardea Biosciences (Nasdaq: RDEA) announced on Monday positive results from the company's two clinical studies of RDEA594, its oral lead drug candidate for the treatment of gout, achieving a 100% response rate.
Gout is a painful, debilitating and progressive disease caused by abnormally elevated levels of uric acid in the blood stream, which leads to needle-like uric acid crystals in and around the connective tissue of the joints and in the kidneys, resulting in inflammation, the formation of disfiguring nodules, intermittent attacks of severe pain and kidney damage.
RDEA594 is an oral, once-daily inhibitor of URAT1, a transporter in the kidney that regulates uric acid excretion from the body. Approximately 90% of gout patients are considered to be under-excretors of uric acid, and recent studies have shown that defects in renal transporters have been genetically linked to gout.
RDEA954 works to increase renal excretion of uric acid by moderating URAT1 transporter activity. The two phase 2 trials tested the effectiveness of RDEA594 in combination with one of the two currently market drugs for gout patients, febuxostat and allopurinol.
While allopurinol and febuxostat account for greater than 90% of U.S. prescriptions for the chronic treatment of gout, approximately one half do not respond well to standard doses of these drugs, according to Ardea.
The first trial, which evaluated the drug with febuxostat in a 21-patient study, concluded that 100% of patients receiving the combo treatment achieved uric acid levels below the target of 6mg/dL, compared to 67% of patients who recieved 40mg of febuxostat alone.
The second 20-patient study, in combination with allopurinal, saw 100% of patients receiving the dual treatment achieve uric acid levels below target, compared with only 20% of patients receiving 300mg of allopurinal alone.
"We are very pleased with these results, which demonstrate the ability of RDEA594 in combination with current standard of care to reduce uric acid levels in gout patients to an extent generally only achieved with intravenous therapy," said president and CEO Barry D. Quart.
Ardea said no clinically relevant drug interactions were observed with RDEA594, and that the treatment was generally well-tolerated.
Aside from RDEA594, San Diego-based Ardea is developing BAY 86-9766, an inhibitor of mitogen-activated ERK kinase (MEK) for the treatment of cancer, being developed under a global license agreement with Bayer HealthCare AG.
The company is also working on two drugs for the treatment of HIV, RDEA806 and RDEA427, which have successfully completed a phase 2a study in HIV patients.
Disclosure: no position