Renovis, Inc., a biopharmaceutical company focused on the discovery and development of drugs to treat neurological diseases and disorders, has announced results of its Phase II clinical trial studying REN-1654 in patient-volunteers with sciatica, a form of neuropathic pain.
The results indicate that, although REN-1654 showed a positive trend in pain relief, it did not reach statistical significance in its primary endpoint of change in average daily spontaneous pain ratings at the end of a three-week treatment period compared to placebo. A planned analysis of secondary endpoints in the study showed a statistically significant reduction in maximum daily leg pain at the end of weeks one and two in subjects treated with REN-1654 compared with placebo, but the reduction in maximum daily leg pain was not statistically significant after three weeks of treatment due to a spontaneous reduction of pain in the placebo group.
REN-1654 is a small molecule inhibitor of the release of TNF-alpha and other proinflammatory cytokines that has shown activity in animal models of neuropathic pain.
"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," Corey S. Goodman, chief executive officer of Renovis said adding, "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."
"While REN-1654 did not meet our expectations in Phase II," commented Dr. Goodman adding, "the encouraging news from Cerovive (NXY-059) in Phase III and the progress of our pre-clinical programs, as highlighted by our research collaborations with Pfizer and Genentech, provide a solid foundation for Renovis to achieve our long-term objectives."