Menlo Therapeutics has reported negative top-line results from the ATOMIK study, a Phase II clinical trial analysing the efficacy, safety and tolerability of serlopitant for the treatment of pruritus in adults and adolescents with a history of atopic dermatitis (AD).
The placebo-controlled trial did not meet its primary or key secondary efficacy objectives and demonstrated no statistically significant difference between the serlopitant treated groups and the placebo treated group.
The trial showed numerical differences favouring the serlopitant treated group at all time points. It also found that serlopitant was well-tolerated among the patients.
The study, which enrolled 484 subjects aged 13 and older, was conducted across 52 sites in the US.
The enrolled patients have a past or present diagnosis of atopic dermatitis pruritus for at least six weeks, and an average weekly worst-itch numeric rating scale, or WI-NRS score ≥ 6 for each of the two weeks of the screening period, as recorded in the eDiary.
During the trial patients were randomised into one of three treatment arms that include once-daily doses of placebo, 1mg serlopitant, or 5mg serlopitant.
The trial features a two-week screening period, a six-week treatment period and a four-week follow-up period.
Its primary efficacy analysis included comparing the mean change in WI‑NRS of serlopitant and placebo from baseline to week six, while its key secondary endpoint was a responder-rate analysis of a four-point WI-NRS improvement at week six.
Menlo Therapeutics CEO Steve Basta said: “While we are disappointed that the results in this Phase II trial of pruritus associated with atopic dermatitis did not reach statistical significance and did not show the same magnitude of treatment effect as in our prior pruritus studies, we do see in the results a pattern that shows numerical improvement in each serlopitant treatment group above the placebo group at every time-point.
“Reduction of pruritus has been demonstrated in two prior Phase II studies, one trial in patients with chronic pruritus and one trial in patients with prurigo nodularis.”
Menlo further noted that the company is set to begin Phase III studies of serlopitant for prurigo nodularis within this quarter.