
Wednesday, June 3, 2009
CombinatoRx notes good results for reworked osteoarthritis drug
By Mass High Tech staff
CombinatoRx Inc. reported positive Phase 1 clinical study results of Synavive, its knee treatment for osteoarthritis. The drug received poor Phase 2b clinical trial results as a twice-daily formulation; the Phase 1 drug is an oral once-daily aligned-release formulation.
The goal of the clinical study was to determine the drug’s bioavailability, its ability to be absorbed into the body.
According to CombinatoRx (Nasdaq: CRXX) officials, the once-daily drug was “well-tolerated and there were no study drug-related serious adverse events reported.” The company found a 30 percent rate of headaches in patients taking the drug. In the company’s prior twice-daily formulation of Synavive, patients reported a 50 percent headache rate.
CombinatoRx’ Phase 1 study involved 24 volunteers over a period of four weeks.
The company’s poor results of its Phase 2b clinical trials for Synavive was brought about by statistically insignificant results in a knee pain measurement test for patients walking on a flat surface for both the placebo and Synavive.
The results of the Phase 2b clinical trials began a series of downfalls for the company that started with a 73 percent drop in stock, a 45 percent cut in workforce, and follow-up job reductions weeks later.
CombinatoRx reported a net loss of $9.4 million on total revenue of $3 million for the first quarter of 2009, ending in March.
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