Menlo says serlopitant fails to demonstrate efficacy in Refractory Chronic Cough

Menlo Therapeutics announced top-line results from TUSSIX, its Phase 2 clinical trial of serlopitant for the treatment of refractory chronic cough. In this 185 patient study, treatment with serlopitant failed to demonstrate benefit versus placebo on the primary and key secondary endpoints. In the primary endpoint analysis of change from baseline in 24-hour cough frequency after 12 weeks of treatment, the serlopitant group had 31% less reduction than the placebo group. In a key secondary analysis of response rates, 54% of placebo treated patients and 44% of serlopitant treated patients experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline. Serlopitant was well-tolerated in this study. Treatment related adverse events occurred at comparable rates in the serlopitant and placebo treated groups. “Based upon the results of this trial, we do not anticipate further development of serlopitant for the treatment of refractory chronic cough. We sincerely thank the patients and investigators who participated in this trial. We are continuing the clinical development of serlopitant for pruritus associated with various conditions given the two successful Phase 2 clinical trials in which serlopitant demonstrated a reduction in chronic pruritus and pruritus associated with prurigo nodularis,” stated Steve Basta, CEO of Menlo Therapeutics. The Phase 2 clinical trial of serlopitant to treat pruritus associated with psoriasis is fully enrolled, and data is expected in December 2018, said the company, which added that it is currently enrolling patients in two Phase 3 clinical trials – one in the U.S. and one in Europe – to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected in the first half of 2020.
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