The Primary Efficacy Endpoint and Multiple Secondary Endpoints of Both Studies Were Met
MENLO PARK, Calif., Sept. 18, 2017 /PRNewswire/ — Menlo Therapeutics Inc. announced today the presentation of data from two phase 2 clinical studies of serlopitant at the 2017 EADV conference, the leading annual dermatology meeting in Europe. A 257-patient phase 2 trial (TCP-101) evaluating serlopitant for the treatment of chronic pruritus (itch) successfully met its primary efficacy endpoint, demonstrating a statistically significant difference in pruritus change from baseline in subjects treated with 1 mg and 5 mg serlopitant compared with placebo (p<0.05 at weeks 4, 5, and 6). Additionally, a post-hoc analysis to evaluate time to onset demonstrated a statistically significant antipruritic benefit observed by day 3 of treatment with 1 mg and 5 mg of serlopitant compared with placebo (p<0.05).
The 257-patient multi-center, randomized, placebo-controlled, trial evaluated treatment with once-daily, orally administered serlopitant 0.25 mg, 1 mg, and 5 mg tablets compared with placebo for 6 weeks. The trial was conducted at 25 clinical study sites in the United States. All enrolled patients had severe pruritus as determined by a visual analog scale (VAS) pruritus score of ≥7cm at screening.
The study successfully demonstrated greater reduction of pruritus with serlopitant compared with control on the primary endpoint analysis for both the 1 mg and 5 mg dose groups (p<0.05 at weeks 4, 5, and 6). At week 6, the serlopitant 1 mg and 5 mg groups reported mean percent reduction from baseline VAS pruritus scores of 41.4% and 42.5%, respectively, as compared with 28.3% in the placebo-treated group. Statistically significant differences in change from baseline NRS pruritus scores (a secondary endpoint) were observed for both serlopitant 1 mg and 5 mg at weeks 4, 5, and 6 compared to placebo (p<0.05). Serlopitant was well tolerated in the TCP-101 study. The majority of treatment-emergent adverse events were mild to moderate in severity.
The safety and efficacy results of this study were presented at the 26th European Academy of Dermatology and Venereology conference by Prof. Dr. Sonja Ständer, Professor of Dermatology and Neurodermatology, head of the Center for Chronic Pruritus of the University Hospital Münster, Germany. The early onset results of the study were presented by Paul Kwon, MD, Chief Medical Officer of Menlo Therapeutics.
In addition to the presentations on the 257-patient chronic pruritus study (TCP-101), results from a separate 127-subject phase 2 study (TCP-102) in patients with prurigo nodularis were presented by Prof. Dr. Sonja Ständer. In this 127-patient study conducted at 15 sites in Germany, serlopitant 5 mg was superior to placebo in the primary endpoint assessment of change from baseline in average-itch VAS score at 8 weeks (p<0.001), and in multiple secondary pruritus endpoints, including NRS and worst-itch VAS scores.
Serlopitant was well tolerated in the TCP-102 study. The majority of treatment-emergent adverse events were mild to moderate in severity.
Serlopitant is a small-molecule, highly potent and selective NK-1 receptor antagonist being developed for the treatment of pruritus in multiple patient populations. Serlopitant is also being evaluated as a potential treatment for refractory chronic cough. Originally developed by Merck and licensed to Menlo Therapeutics in 2012, serlopitant has been evaluated in more than 1,000 human clinical trial subjects. Serlopitant is an investigational drug that is not currently approved for use in any indication.
About Prurigo Nodularis
Prurigo nodularis is a chronic 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 severe itching often experienced by these patients.
About Menlo Therapeutics Inc.
Menlo Therapeutics Inc. is a clinical stage pharmaceutical company dedicated to the development of serlopitant, a once-daily oral NK1 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/.