Menlo Therapeutics says serlopitant met primary endpoint in trial

Menlo Therapeutics announced top-line results from MTI-109, a 204-patient Phase 2 clinical trial of serlopitant for the treatment of pruritus associated with psoriasis. The trial successfully met its primary endpoint, showing a statistically significant reduction in pruritus based upon a 4-point improvement responder analysis. In the trial, 33% of patients treated with serlopitant 5 mg daily achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 8 compared to baseline vs. 21% of patients treated with placebo. The trial also prospectively defined three key secondary endpoints for sequential step-down analyses at week 4 and days 7 and 3. The trial successfully met the secondary endpoint of WI-NRS responder rate at week 4. At week 4, 21% of patients treated with serlopitant achieved a 4-point or greater improvement on the WI-NRS vs. 11% of patients treated with placebo. Assessment of the secondary endpoints of the absolute change in WI-NRS from baseline to day 7 and day 3 for serlopitant compared to placebo showed a greater numerical, but not statistically significant, improvement for the serlopitant group. At every assessed time point in the trial, the serlopitant treated group demonstrated greater numerical improvement than the placebo group in both the WI-NRS 4-point responder analysis and in the mean change in WI-NRS from baseline. Serlopitant was well-tolerated in this clinical trial. No serious adverse events were reported for serlopitant treated patients. Treatment-emergent adverse events assessed as likely related to treatment were observed with similar frequency in both groups. The consolidated safety summary for serlopitant now includes more than 1,600 evaluable patients, including patients who have received treatment for up to one year.
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