South San Francisco-based Renovis has decided to stop developing an experimental agent for neuropathic pain as an oral agent after it flunked a Phase II trial. REN-1654 failed to hit either its primary or secondary endpoints in the mid-stage trial, falling short of statistical significance in providing pain relief compared to a placebo. The drug also failed to demonstrate statistical significance in reducing daily leg pain. Researchers say they will now try to determine if the drug would be effective through an alternative route.
"We are disappointed that the two proof-of-concept studies we completed this year with REN-1654 in sciatica and PHN patients do not support further development of REN-1654 as an oral drug," said Corey S. Goodman, PhD, CEO of Renovis. "The finding that REN-1654 may provide a modest degree of relief of leg pain for sciatica patients is consistent with published data from several small open-label studies using infliximab or etanercept injections in human patients, which suggested that a reduction of TNF-alpha levels could be a potential treatment for sciatica leg pain. While we will not continue to develop REN-1654 as an oral medication, we will continue to analyze the data from this study to consider whether there may be alternative routes for advancing this compound or mechanism of action."
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