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Stanford Researchers Presented Results from an Exploratory Study of Serlopitant for the Treatment of Chronic Itch in Epidermolysis Bullosa Patients Indicating Reduction in Itch with Serlopitant Treatment

May 21, 2018 at 8:30 AM EDT
Results Presented at the International Investigative Dermatology Meeting

REDWOOD CITY, Calif., May 21, 2018 (GLOBE NEWSWIRE) -- 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 from an exploratory study of serlopitant for the treatment of chronic itch in epidermolysis bullosa (EB) patients was presented by a research team from Stanford University in an oral presentation at the International Investigative Dermatology meeting on May 18, 2018 in Orlando, Florida.

The exploratory study was conducted independently by a Stanford University EB research team as an investigator-sponsored, double-blind, parallel arm, placebo-controlled, randomized clinical trial evaluating the comparative effect of serlopitant 5 mg, versus placebo in the treatment of chronic pruritus in 14 EB patients ages 13 years and older.  Seven patients were treated with serlopitant, and seven with placebo. This was an exploratory study to determine if there is any indication that serlopitant may provide benefit to EB patients by reducing itch.  As an exploratory study with only 14 patients, the study was not powered to detect statistically significant treatment effects at the magnitudes observed in this trial.

Efficacy at reducing itch was evaluated based upon a change in Numeric Rating Scale (NRS) itch score from baseline over the eight-week treatment period.  After eight weeks of treatment, there was a numerically greater decrease in NRS itch score of 2.1 in the serlopitant treated group versus a decrease of 1.5 in the placebo treated group (p=0.11).   More patients in the active group (43% vs. 14%) achieved at least a three-point reduction in NRS itch score by the end of treatment as compared to placebo.   

Serlopitant was well-tolerated in this study with no new observed safety signals. 

“We were pleased to see a greater reduction in pruritus in the serlopitant arm than in the placebo arm,” said Albert Chiao, MD, MBA, Clinical Assistant Professor of Dermatology, Stanford University School of Medicine.  “This is an important finding in EB, as these patients experience significant pruritus, which has proven very difficult to manage.”

“The findings of this exploratory study in EB patients further support the potential of serlopitant as a therapy to reduce pruritus,” said Paul Kwon, MD, Menlo’s Chief Scientific Officer.

The study was supported by the Epidermolysis Bullosa Research Partnership and the Epidermolysis Bullosa Medical Research Foundation

About Serlopitant

Serlopitant is a once-daily NK1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with 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 1,300 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 Epidermolysis Bullosa

EB is a group of rare inherited skin disorders characterized by skin fragility and blistering.  Chronic pruritus is a lifelong challenge in EB and has been reported to be the most distressing disease-related symptom. There have been no new drugs approved for pruritus in EB, and the current management of pruritus in EB with antihistamines and topical corticosteroids only minimally relieves itch.

About Menlo Therapeutics

Menlo Therapeutics Inc. is a late-stage biopharmaceutical company focused on the development of serlopitant, a once-daily oral NK1 receptor antagonist, for the treatment of pruritus associated with various underlying dermatologic conditions and for refractory chronic cough. The Company’s clinical development program for serlopitant includes ongoing Phase 2 studies for the treatment of pruritus associated with psoriasis and refractory chronic cough and ongoing and planned Phase 3 studies for the treatment of pruritus associated with prurigo nodularis.

Forward Looking Statements

This press release contains forward-looking statements, including but not limited to the potential of serlopitant to treat pruritus associated with epidermolysis bullosa, psoriasis, and prurigo nodularis, or to treat refractory chronic cough. 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 future clinical 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 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’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 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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Investor Contact: dsheel@menlotx.com

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Source: Menlo Therapeutics Inc.