Menlo Therapeutics announces results from Phase 2 trial of serlopitant
Menlo Therapeutics presented results from its Phase 2 clinical trial of serlopitant for the treatment of pruritis in patients with psoriasis in an oral presentation at the 28th Congress of the European Academy of Dermatology and Venereology. The results demonstrated a statistically significant reduction in pruritis in patients treated with serlopitant, compared to placebo, and further demonstrated consistent benefit favoring serlopitant when evaluating response rates across patient demographic categories assessed in this study. Pruritis is reported by patients to be one of the most severe and troublesome symptoms of psoriasis. The psoriasis trial reported at EADV successfully met its primary endpoint, showing a statistically significant reduction in pruritus based upon a 4-point improvement responder analysis. In the trial, 33% of patients treated with serlopitant 5 mg daily achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 8 compared to baseline vs. 21% of patients treated with placebo. Additionally, the 4-point responder rate at week 8 was higher in serlopitant-treated patients than in patients in the placebo group when evaluating groups segmented by baseline characteristics: age, gender, weight, percentage of body surface area affected by psoriasis lesions, itch severity, or severity of psoriasis. Serlopitant was well-tolerated in this clinical trial. No serious adverse events were reported for serlopitant-treated patients. Treatment-emergent adverse events assessed as likely related to treatment were observed with similar frequency in both groups.. No serious adverse events were observed in patients treated with serlopitant. The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled clinical trial which evaluated the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus associated with psoriasis. The trial enrolled patients between 18 and 80 years of age with the diagnosis of plaque psoriasis for at least 6 months prior to randomization and with plaques covering less than or equal to 10% body surface area. In addition, patients had pruritus of at least 4 weeks duration prior to screening and a WI-NRS score consistent with severe pruritus at screening. Patients were randomized 1:1 to receive either serlopitant 5 mg or placebo orally once daily and were not allowed to use any other psoriasis therapy, other than bland emollients, for the duration of the trial. The primary efficacy endpoint was a responder analysis of the proportion of patients in each group achieving a 4-point WI-NRS improvement at week 8 compared to baseline. As a randomized Phase 2 trial, the pre-defined statistical threshold for significance was a p-value of less than 0.05.