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news.NeurogesX has reported preliminary top-line results from study C119, its second Phase III clinical trial of NGX-4010, the company's dermal patch drug candidate, in patients with HIV-distal sensory polyneuropathy or HIV-DSP.
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The prespecified analysis of the primary endpoint, comparing all patients treated with NGX-4010 compared to all patients treated with the control patch, did not meet statistical significance (p=0.1), with the overall NGX-4010 treatment group achieving a 29.5% reduction in pain from baseline over weeks two to 12 compared to a 24.6% reduction for the control group. The results were confounded by a much higher than anticipated control group response overall and, in particular, in the 60-minute control arm.
Jeffrey Tobias, chief medical officer of NeurogesX, said: “We observed responses in the NGX-4010 treatment arms consistent with what we have seen in multiple previous studies. However, the response in the 60-minute control group was greater than anticipated. Since these results are preliminary, we have more analysis to carry out on this data. We will continue to evaluate whether the cumulative clinical data from our clinical studies may be able to support evidence of efficacy in HIV-DSP.”