REDWOOD CITY, Calif., February 20, 2018 — Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant, for the treatment of pruritus associated with various underlying dermatologic conditions and for refractory chronic cough, today announced that data assessing the safety and efficacy of serlopitant, the company’s NK-1 receptor antagonist, in treating chronic pruritus was published in the Journal of the American Academy of Dermatology (JAAD).
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 United States. All enrolled patients had severe pruritus as determined by a visual analog scale (VAS) pruritus score of ≥70mm at screening.
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 European Academy of Dermatology and Venereology conference by Professor Dr. Sonja Ständer, Professor of Dermatology and Neurodermatology, head of the Center for Chronic Pruritus of the University Hospital Münster, Germany. Data on the early onset of effect of serlopitant in this study were presented at the same conference by Paul Kwon, MD, Chief Medical Officer of Menlo Therapeutics.
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. Menlo Therapeutics has completed two Phase 2 studies with serlopitant showing a statistically significant reduction in pruritus compared to placebo. Originally developed by Merck and licensed to Menlo Therapeutics in 2012, serlopitant has been evaluated in more than 1,000 patients and has been shown to be well-tolerated, including in patients who have received treatment for up to a year. Serlopitant is an investigational drug that is not currently approved for use in any indication.
About Menlo Therapeutics
Menlo Therapeutics Inc. is a late-stage biopharmaceutical company focused on the development of serlopitant, a once-daily oral NK-1 receptor antagonist, for the treatment of pruritus associated with various underlying dermatologic conditions and for refractory chronic cough. The company has initiated a broad clinical development program for serlopitant including Phase 2 studies for the treatment of pruritus associated with atopic dermatitis, pruritus associated with psoriasis, and refractory chronic cough, and expects to start Phase 3 trials for the treatment of pruritus associated with prurigo nodularis in the first half of 2018. Menlo Therapeutics has worldwide rights to serlopitant, excluding Japan where Menlo Therapeutics has licensed serlopitant to JT Torii.
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 Menlo Therapeutics will need to raise additional capital, risks of competition and the risk that Menlo Therapeutics is not able to successfully defend or protect its intellectual property. For more information about these and other risks, see Menlo Therapeutics’ form S-1/A filed with the Securities and Exchange Commission on January 23, 2018, under the heading “Risk Factors” and any subsequent current and periodic reports filed with the Securities and Exchange Commission. Menlo Therapeutics undertakes no obligation to update these forward-looking statements.
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