Most gout patients are treated with the nearly 50-year-old drug allopurinol, which is used to reduce the levels of uric acid that cause the painful inflammation of gout. But fewer than half of gout patients respond to allopurinol. BioCryst’s compound BCX4208 is being studied as a way to boost the effectiveness of allopurinol in that group of patients who don’t respond to the drug.
Durham, North Carolina-based BioCryst released positive phase 2b trial results from a 12-week study today, which showed that patient response rates for BCX4208 as an add-on therapy to allopurinol ranged from 33 percent to 49 percent. The response rate for the placebo was 18 percent. The BCX4208 results were good enough to show statistical significance in three out of four patient groups in the trial. Investors liked the results, which bumped BioCryst’s shares up more than 14 percent on the news.
But while BioCryst’s trial results are good, The Street’s Adam Feuerstein notes that they’re not nearly as good as the trial results from a competing experimental gout treatment. San Diego biotechnology company Ardea Bioscience (NASDAQ:RDEA) is studying its drug lesinurad in the same kind of patients who don’t respond to allopurinol alone. Ardea’s results earlier this year showed that lesinurad produced response rates between 70 percent and 80 percent compared to 28 percent for a placebo.
BioCryst aims to develop a drug that could help the approximately 17.6 million gout patients worldwide. The company studied BCX4208 in a phase 2a study whose results last year showed a reduction in uric acid. But BioCryst opted for and invested in additional studies to get more data. The company is banking on strong phase 2b results to land a drug partner who could take BCX4208 into phase 3 studies.
Dr. William Sheridan, BioCryst’s senior vice president and chief medical officer, said that six-month results from the ongoing extension study are expected in early 2012 and the phase 2 trials will be completed in the first half of next year. Those results will be part of discussions with regulators and potential drug partners. Those potential partners will want to see why they should invest their time and money in BCX4208 if Ardea’s gout drug candidate works better. Ardea is already planning its phase 3 studies for lesinurad.