GlaxoSmithKline (NYSE:GSK) and drug partner Human Genome Sciences (NASDAQ:HGSI) have started clinical trials on a different version of lupus drug Benlysta that would be easier to administer to patients.
Benlysta is currently administered by intravenous infusion. The companies have started a phase 3 clinical trial to test a once-a-week injectable version of the drug. Studies are being conducted at 200 sites around the world. GSK and HGS expect initial results in the second half of 2014. The primary efficacy endpoint of the trial is a response rate after one year.
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Benlysta received U.S. Food and Drug Administration approval in March, becoming the first new lupus treatment in more than 50 years. London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, has partnered with Maryland-based HGS on the drug since 2006.
The Lupus Foundation of America estimates that 5 million people worldwide live with some form of the disease. HGS’ own research estimates that 200,000 patients in the United States have been diagnosed with moderate-to-severe lupus that could benefit from treatment with Benlysta.
An injectable version of Benlysta would be welcome by rheumatologists. BioTrends Research Group, which has been tracking Benlysta since its launch, has surveyed rheumatologists about the drug. The firm said that surveyed rheumatologists see Benlysta’s main benefit being its novel mechanism of action. But one of the drawbacks rheumatologists cite is its intravenous administration.
Benlysta generated net sales of $18.8 million in sales in the third quarter; $26.6 million for the first nine months of 2011. Since becoming available in the United States, the drug has also launched in Germany, Canada, Austria, Denmark, Finland, Hungary, Norway and Sweden.