Menlo Therapeutics’ Phase 2 Serlopitant Study for the Treatment of Chronic Pruritus Published in the Journal of the American Academy of Dermatology
The manuscript describes results from the company’s phase 2 study (TCP-101) evaluating the safety and efficacy of serlopitant in patients with chronic pruritus (itch). The 257-patient multi-center, randomized, placebo-controlled, study evaluated treatment with once-daily, orally administered serlopitant 0.25 mg, 1 mg, and 5 mg tablets compared with placebo for 6 weeks. The study was conducted at 25 clinical study sites in
The study successfully met its primary efficacy endpoint, demonstrating a statistically significant difference in the change from baseline in pruritus, in subjects treated with either 1 mg or 5 mg serlopitant compared with placebo (p<0.05 at weeks 4, 5, and 6).
At week 6, the mean percent reduction from baseline VAS pruritus scores in the serlopitant 1 mg and 5 mg groups were 41.4% and 42.5%, respectively, as compared with 28.3% in the placebo-treated group. Statistically significant differences in change from baseline numeric rating scale (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 previously presented at the 26th
The publication, “Serlopitant for the treatment of chronic pruritus: results of a randomized, multicenter, placebo-controlled phase 2 clinical trial,” is available on line at the JAAD’s website at http://www.jaad.org/article/S0190-9622(18)30315-3/fulltext.
Serlopitant is a once-daily NK-1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with atopic dermatitis, psoriasis, and prurigo nodularis. Serlopitant is also being evaluated as a potential treatment for refractory chronic cough, a cough which persists for greater than eight weeks despite treatment of any identified underlying cause.
Forward Looking Statements
This press release contains forward-looking statements, including but not limited to the potential of serlopitant to treat pruritus associated with atopic dermatitis, psoriasis, and prurigo nodularis, or to treat refractory chronic cough, the conduct of Phase 2 clinical studies, and expectations about the start of Phase 3 clinical trials. Such forward-looking statements involve substantial risk and uncertainties that could cause Menlo Therapeutics’ development program for serlopitant, future results, achievements or performance to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks that the timing of enrollment or commencement of clinical trials may be delayed, the risk that subsequent trials do not replicate the results from completed clinical trials, the risk of adverse safety events, risks that the costs of clinical trials will exceed expectations and that
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Source: Menlo Therapeutics Inc.