Menlo Therapeutics announced topline results from two phase 3 studies of serlopitant for the treatment of pruritus associated with prurigo nodularis.

Serlopitant is an oral small molecule, highly selective NK1-R antagonist. The randomized, double-blind, placebo-controlled studies (MTI-105 and MTI-106) assessed the efficacy and safety of serlopitant in adult patients with pruritus associated with prurigo nodularis. Patients were randomized 1:1 to receive serlopitant 5mg tablets or placebo. The primary end point was 4-point improvement from baseline in the worst-itch numeric rating scale (WI-NRS) score at week 10.

Findings from both trials demonstrated that serlopitant did not meet the primary end point of statistically significant reduction in pruritus. In the MTI-105 study (N=285), 26.45% of patients treated with serlopitant achieved a 4-point responder rate at week 10 compared with 20.31% in the placebo arm (P =.229). In the MTI-106 study (N=295), 25.9% of serlopitant-treated patients achieved a 4-point responder rate at week 10 compared with 18.95% of those administered placebo (P =.158).

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“While the data showed a numerical advantage for serlopitant compared with placebo on the primary end point, the difference was not statistically significant,” said David Domzalski, CEO of Menlo Therapeutics Inc. “We will thoroughly analyze these data to better understand the outcome but, at this point, we do not intend to further pursue serlopitant.”

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