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news.Biopharmaceutical company Renovis has discontinued development of REN-1654 in shingles after the treatment candidate failed to provide significant pain relief compared to placebo in a phase II study.
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The primary endpoint of the study was a change in average weekly daily spontaneous pain ratings at week three compared to baseline. Pain scores were based on an 11-point numerical scale, which ranged from zero (no pain) to ten (most severe pain possible). In the analysis, 30% of placebo-treated subjects achieved pain reduction of one point or greater in their measured response after three weeks, compared with 33% of subjects who received 30mg of REN-1654 and 37% who received 100mg of REN-1654.
“We are disappointed that the data for the primary endpoint did not reach statistical significance between the placebo and dose groups for REN-1654,” said Dr Randall Moreadith, chief medical officer of Renovis. “Despite the fact that this was a proof-of-concept study and the first time an agent with this mechanism of action has been evaluated in this population of PHN patients, these data did not meet our objectives for advancing REN-1654 for this indication.”
Although it has stopped development in post-herpetic neuralgia (PHN), Renovis is continuing enrollment as planned in its second phase II clinical trial with REN-1654 in sciatica. The company expects to announce results from this trial by the end of the third quarter of 2005.