Menlo Therapeutics Inc. (Menlo Park, CA) announced today that the phase 2 trial (TCP-102) evaluating serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis successfully met its primary efficacy endpoint and key secondary endpoints, demonstrating a statistically significant reduction in pruritus (p<0.001 for the primary efficacy analysis at week 8) in subjects treated with serlopitant compared with placebo.
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.
Results of the trial demonstrated that serlopitant 5 mg provided a statistically significant greater reduction of pruritus in the serlopitant-treated group compared with the placebo group. 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 by Dr. Sonja Ständer, Professor for Dermatology and Neurodermatology, head of the Interdisciplinary Competence Center Chronic Pruritus (KCP) of the University Hospital Münster, Germany, and lead investigator in the study. Dr. Ständer commented regarding the findings, “there is no adequate therapy today to control pruritus in prurigo nodularis. Serlopitant represents a meaningful advance in prurigo nodularis treatment, as the most important clinical objective in prurigo nodularis patients is to reduce the pruritus.”
The safety and efficacy results from this study are consistent 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.
Serlopitant is a small-molecule, highly potent and selective NK1-R antagonist being developed for the treatment of pruritus in multiple patient populations. Serlopitant has demonstrated ≥19,000-fold selectivity for NK1-R over other human receptors, enzymes, and transporters tested. Originally developed by Merck and licensed to Menlo Therapeutics in 2012, serlopitant has been evaluated in more than 1,000 human clinical trial subjects in 13 phase 1 and four phase 2 studies. Serlopitant is an investigational product that is not currently approved for use in any indication.
About Prurigo Nodularis
Prurigo nodularis is a dermatologic condition characterized by the presence of highly pruritic nodules and papules on the skin. Currently, there are no approved treatments for prurigo nodularis, and there is a high level of unmet need to treat the profound itching experienced by these patients often for many years.
About Menlo Therapeutics Inc.
Menlo Therapeutics Inc., formerly Tigercat Pharma, Inc., is a clinical stage pharmaceutical company dedicated to the development of serlopitant, a once-daily oral NK1-R antagonist, for the treatment of pruritus. Menlo Therapeutics is funded by leading healthcare investors Vivo Capital (http://vivocapital.com), Presidio Partners (http://presidiopartners.com), Remeditex Ventures, LLC (http://www.remeditex.com) and F-Prime Capital (http://fprimecapital.com). More information is available at http://menlotherapeutics.com/.