Menlo Therapeutics Inc.’s Serlopitant performed well in phase 2 trial (TCP-102) evaluating it as a treatment of pruritus associated with prurigo nodularis, successfully meeting its primary efficacy endpoint and key secondary endpoints.
There are no currently approved treatments for prurigo nodularis,
The 127-subject multi-center, randomized, placebo-controlled, trial evaluated treatment with once-daily, orally administered serlopitant 5 mg tablets compared with placebo for 8 weeks. The trial was conducted at 15 clinical study sites in Germany. All enrolled subjects had severe pruritus as determined by a visual analog scale (VAS) pruritus score ≥7 on a 0-10 scale at screening. Serlopitant is a small-molecule, highly potent and selective neurokinin receptor 1 (NK1) antagonist. Substance P and its receptor, NK1, have been implicated by a number of preclinical and clinical studies to be important in the origin of pruritus.
Serlopitant 5 mg provided a statistically significant greater reduction of pruritus in the serlopitant-treated group compared with the placebo group, the study showed. At 8 weeks, the serlopitant-treated group reported a 48% reduction in average pruritus severity as compared with a 26% reduction in the placebo-treated group. A statistically significant greater reduction of pruritus in the serlopitant 5 mg group compared with control was observed at every evaluation timepoint (weeks 2, 4, and 8) on the primary measure of pruritus in the study. Multiple additional measures of itch in this study confirmed the findings of reduced pruritus in serlopitant-treated subjects vs. the placebo group.
Serlopitant was well tolerated in this trial and had an overall safety profile comparable with placebo. Observed adverse events were generally mild to moderate.
The results of this study were presented at the 2017 Annual Meeting of the American Academy of Dermatology,
The safety and efficacy results from this study are in line with results from a prior 257-participant phase 2 trial (TCP-101) in patients with chronic pruritus conducted at 25 sites in the United States.