Xoma drug fails to beat out a placebo in PhII osteoarthritis study

After the markets closed on Tuesday, Xoma put out the word that its main pipeline asset, gevokizumab (Xoma 052), flunked a Phase II program for erosive osteoarthritis of the hand, ending any shot it had at a broad pivotal study in that indication. The Berkeley, CA-based biotech ($XOMA) says that it will now go back over the data to see if there were any subgroup responses worth pursuing as they make up their minds on what to do with the program.

Initially, investigators say, the treatment performed better than a placebo, but the placebo arm rallied in the final three months of the 6-month study, wiping out any advantage for the therapy. The drug will continue in Phase III studies for noninfectious and Behçet's uveitis, however.

Gevokizumab is Xoma's main claim to fame. The biotech is pursuing 6 different clinical studies of gevokizumab, according to its website, while Servier is down for 5 more. A few days ago, the company reported that the IL-1 beta modulating antibody was granted an orphan drug designation by the FDA for the treatment of pyoderma gangrenosum.

"We launched our proof-of-concept program for gevokizumab just over two years ago," said CEO John Varian in a statement. "We developed a thoughtful plan that would allow data derived from well-designed clinical studies using gevokizumab to lead us to the best opportunities to follow our ongoing Phase III studies in non-infectious and Behçet's uveitis. While we are disappointed in today's results, the new information we received from these Phase II studies informs our next decisions. The data we generated in our erosive osteoarthritis of the hand studies enabled our decision not to initiate large Phase III studies for this indication. In contrast, the data that we generated last fall in pyoderma gangrenosum allowed us to select this orphan indication as our next Phase III effort. The data Servier and we are generating in six additional indications we have disclosed, as well as other indications we haven't yet disclosed, will continue to light our pathway forward."

- here's the press release

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