Menlo Therapeutics Announces Results from a Phase 2 Trial of Serlopitant for Pruritus Associated with Atopic Dermatitis
|Endpoint||Placebo||Serlopitant 1 mg||Serlopitant 5 mg|
Mean Change from Baseline
|Absolute Change||Absolute Change||Treatment Effect(1)||Absolute Change||Treatment Effect(1)|
|WI-NRS mean change from baseline at week 2||-1.13||-1.42||-0.29||-1.29||-0.16|
|WI-NRS mean change from baseline at week 4||-1.66||-1.79||-0.13||-1.78||-0.12|
|WI-NRS change mean from baseline at week 6 (Primary Endpoint)||-2.01||-2.32||-0.32 (p=0.11)||-2.25||-0.23
Responder Rate Analysis
|Response Rate||Response Rate||Treatment Effect(2)||Response Rate||Treatment Effect(2)|
|NRS ≥ 4-point responder rate at week 6 (Secondary Endpoint)||16.5||%||22.4||%||5.9% (p=0.09)||20.6||%||4.2%
(1) Treatment effect represents the difference between the absolute change in the serlopitant treated groups vs. the absolute change in the placebo treated group.
(2) Treatment effect represents the difference between the response rate in the serlopitant treated groups vs. the response rate in the placebo treated group.
“While we are disappointed that the results in this Phase 2 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 timepoint. This is our third pruritus study of serlopitant. Reduction of pruritus has been demonstrated in two prior Phase 2 studies, one trial in patients with chronic pruritus and one trial in patients with prurigo nodularis,” stated
Serlopitant was well-tolerated in this study. No serious adverse events were assessed as likely related to serlopitant. Treatment-emergent adverse events that were assessed as possibly related to treatment were observed with similar frequency in all three study groups (9.5% for placebo, 7.5% for 1 mg, and 8.1% for 5 mg). The only treatment emergent adverse events that were reported in more than 5% of patients in any study group were worsening of atopic dermatitis (3.2% for placebo, 1.3% for 1 mg, and 5.6% for 5 mg) and worsening of pruritus (5.1% for placebo, 5.6% for 1 mg, and 1.9% for 5 mg). The consolidated safety summary for serlopitant now includes more than 1,300 patients that have been evaluated, including patients who have received treatment for up to a year.
The ATOMIK, MTI-103 study, was a multi-center, randomized, placebo-controlled Phase 2 clinical trial conducted at 52 US sites to assess the efficacy, safety and tolerability of serlopitant. The study enrolled 484 subjects ages 13 years of age and older with 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. Patients were randomized into one of three treatment arms: once-daily doses of placebo, 1 mg serlopitant, or 5 mg serlopitant. The trial included a two-week screening period, a six‑week treatment period and a four‑week follow-up period. This trial was intended to evaluate if treatment with either 5 mg or 1 mg serlopitant daily for six weeks could reduce pruritus associated with atopic dermatitis compared with placebo. The primary efficacy analysis compared the difference between serlopitant and placebo in the mean change in WI‑NRS from baseline to week 6. A key secondary endpoint was a responder-rate analysis of a 4-point WI-NRS improvement at week 6.
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Serlopitant is a once-daily NK1 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 anticipated announcement of results of Phase 2 clinical studies for refractory chronic cough and pruritus associated with psoriasis, and expectations about the start of Phase 3 clinical trials for pruritus associated with prurigo nodularis. 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 or do not demonstrate efficacy of serlopitant in the studied indications, the risk of adverse safety events, risks that the costs of clinical trials will exceed expectations, risks that
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Source: Menlo Therapeutics Inc.