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Menlo Therapeutics Announces Publication of Serlopitant Phase 2 Data for the Treatment of Pruritus Associated with Prurigo Nodularis

1153 Days ago

Data Published in the Journal of the American Academy of Dermatology

REDWOOD CITY, Calif., March 25, 2019 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced the publication of the company’s Phase 2 trial of serlopitant for the treatment of pruritus associated with prurigo nodularis (PN) in the Journal of the American Academy of Dermatology (JAAD).

The previously presented trial results were published in the March 17, 2019 online JAAD and demonstrate that serlopitant reduced pruritus in patients with treatment-refractory PN and was well-tolerated.  The study met its primary and multiple secondary efficacy endpoints of pruritus reduction in patients in the serlopitant treatment group compared with placebo.  

In this randomized, double-blind, placebo-controlled study, 128 patients with chronic, treatment-refractory PN for more than 6 weeks received serlopitant, 5 mg, or placebo orally once daily for 8 weeks. For the primary endpoint assessment, pruritus scores were measured using the average itch visual analog scale.  Pruritus scores improved significantly more in patients treated with serlopitant than in patients treated with placebo.  For the primary endpoint assessment, at weeks 4 and 8: the least squares mean difference (serlopitant minus placebo) was -1.0 at week 4 (p = 0.02) and -1.7 at week 8 (p<0.001). The least squares mean difference between serlopitant and placebo reached statistical significance at week 2 (-0.9 [p = .011]).

“Itch is the primary complaint among patients with prurigo nodularis and has a significant impact on quality of life. There are currently no approved treatments in the U.S. or Europe for pruritus associated with prurigo nodularis so patients and physicians are in need of a safe, effective treatment for the itch associated with this chronic condition,” said Sonja Ständer, M.D., professor for Dermatology and Neurodermatology at the Department of Dermatology, and head of the Interdisciplinary Center for Chronic Pruritus (KCP) of the University Hospital Münster, Germany.  “These Phase 2 results of serlopitant for the treatment of pruritus associated with prurigo nodularis are very important as serlopitant demonstrated a significant reduction in pruritus relative to placebo and could be an important treatment option for patients and physicians, if approved.”

“The results of this study led to the initiation of our current Phase 3 trials and supported the FDA’s recent Breakthrough Therapy designation for serlopitant as a treatment for pruritus associated with prurigo nodularis,” said Steve Basta, Chief Executive Officer of Menlo Therapeutics.  “We sincerely thank the participants and investigators involved in this study for their dedication and contributions to advancing development of a potential treatment for pruritus associated with prurigo nodularis.”

About Prurigo Nodularis

Prurigo nodularis is a severely pruritic chronic skin disorder affecting primarily older adults and is characterized by multiple, firm, itchy nodules typically found on a patient’s arms, legs and trunk. We estimate that there are approximately 300,000 – 600,000 people with prurigo nodularis in the United States. Prurigo nodularis results from a vicious cycle of repeated itching and scratching leading to formation of raised, inflamed skin nodules that can develop sores or become hard and crusty. The itching sensation in prurigo nodularis is extreme and often leads to scratching to the point of bleeding or pain. Prurigo nodularis may be associated with a variety of dermatologic and systemic diseases such as atopic dermatitis, psoriasis, diabetes, chronic renal failure and HIV infection.

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. The company’s clinical development program for serlopitant includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a planned Phase 3 program for the treatment of pruritus associated with psoriasis, and a Phase 2 clinical trial for the treatment of chronic pruritus of unknown origin.

Forward Looking Statements  

To the extent that statements contained in this press release are not descriptions of historical facts regarding Menlo Therapeutics, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including, but not limited to, statements regarding Menlo Therapeutics’ expectations regarding the safety and efficacy of serlopitant, the timing and success of ongoing clinical trials, and the timing of and receipt of regulatory approval.  Such forward-looking statements involve substantial risk and uncertainties that could cause Menlo Therapeutics’ development program for serlopitant, future financial 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 results, 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 resulting from the unpredictability of the regulatory process and regulatory developments in the United States and foreign countries, and risks that Menlo Therapeutics will need to raise additional capital and will be unable to do so on favorable terms or at all. These factors, together with those that are described in greater detail in Menlo Therapeutics’ Annual Report on Form 10-K filed on February 28, 2019, as well as any reports that it may file with the SEC in the future, may cause Menlo Therapeutics’ actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Menlo Therapeutics undertakes no obligation to update or revise any forward-looking statements.

Media Contact: media@menlotx.com

Investor Contact: dsheel@menlotx.com

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