Studies MTI-105 and MTI-106 of oral serlopitant did not meet their respective primary endpoint of reduction of pruritus.-Menlo Therapeutics

Menlo Therapeutics Inc. announced top line results from two Phase III clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN), studies MTI-105 and MTI-106.

Study MTI-105 enrolled 285 patients in the US and study MTI-106 enrolled a total of 295 patients from Germany, Poland and Austria. Patients were randomized 1:1 to either serlopitant 5mg or placebo treatment.

Study MTI-105 and Study MTI-106 did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis.

In study MTI-105, 26.45% of patients in the serlopitant group achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 10 compared to baseline (primary efficacy endpoint) vs. 20.31% of patients treated with placebo (p=0.229). In study MTI-106, 25.90% of patients in the serlopitant group achieved a 4-point or greater improvement on the WI-NRS at week 10 compared to baseline (primary efficacy endpoint) vs. 18.95% of patients treated with placebo (p=0.158). Results for all supportive sensitivity analyses for the primary endpoint were comparable to the primary analyses for both studies.