Menlo Therapeutics has reported negative top-line results from the Phase ll MTI-110 (TUSSIX) clinical trial that evaluated serlopitant for the treatment of refractory chronic cough.
The trial, which enrolled 185 patients, failed to meet its primary and key secondary endpoints of providing improved benefits by serlopitant over placebo.
Results demonstrated that in the primary endpoint review of change from baseline in 24-hour cough frequency after 12 weeks of treatment, the serlopitant group witnessed 31% less reduction than the placebo group.
In a key secondary evaluation of response rates, it was found that 54% of patients receiving placebo and 44% of patients treated with serlopitant experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline.
However, Serlopitant was reported to be well-tolerated in the trial.
Adverse events associated with treatment occurred at comparable rates in both the serlopitant and placebo groups.
Menlo Therapeutics CEO Steve Basta said: “Based upon the results of this trial, we do not anticipate further development of serlopitant for the treatment of refractory chronic cough.
“We are continuing the clinical development of serlopitant for pruritus associated with various conditions given the two successful Phase ll clinical trials in which serlopitant demonstrated a reduction in chronic pruritus and pruritus associated with prurigo nodularis.”
In addition, Menlo is currently enrolling patients in two Phase lll clinical trials to investigate serlopitant as a treatment for pruritus associated with prurigo nodularis.
The results from each trial are expected to be available in the first half of 2020.
Serlopitant is an investigational, once-daily neurokinin 1 (NK1) receptor antagonist that aims to treat pruritus, or itch, associated with several conditions.