MNLO Menlo Therapeutics Inc

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 psoriasis in the Journal of the American Academy of Dermatology (JAAD).

The trial results were published in the February 3, 2020, online JAAD and demonstrate that serlopitant significantly reduced pruritus in patients with psoriasis and was well-tolerated. The trial successfully met its primary endpoint, showing a statistically significant reduction in pruritus compared to placebo at week 8 based upon a 4-point improvement responder analysis. The trial results were previously presented at the European Academy of Dermatology and Venereology Meeting last year.

“We are pleased with the growing body of evidence that supports the activity of serlopitant to treat pruritus in multiple indications,” said Steve Basta, chief executive officer of Menlo Therapeutics. “We look forward to upcoming results from our Phase 2 trial of serlopitant in chronic pruritus of unknown origin expected in late-February and our Phase 3 trials for the treatment of pruritus associated with prurigo nodularis expected in March or April. We thank the patients and investigators involved in this study for their dedication and contributions to advancing development of serlopitant for treatment for pruritus associated with psoriasis.”

In this randomized, double-blind, placebo-controlled study, 204 patients with psoriasis received 5 mg serlopitant or placebo orally once daily for 8 weeks. For the primary endpoint assessment, pruritus scores were measured using the worst-itch numeric responder scale (WI-NRS). The study met its primary endpoint, with 33.3% of patients treated with serlopitant achieving a 4-point improvement from baseline on the WI-NRS at week 8 compared with 21.1% of placebo recipients (P=0.028). In addition, the study met a key secondary endpoint, with 20.8% of patients treated with serlopitant achieving a 4-point improvement from baseline on the WI-NRS at week 4 vs 11.5% of placebo recipients (P=0.039). Other key secondary endpoints were the mean absolute change in WI-NRS from baseline to day 3 and day 7, which were numerically greater for serlopitant than placebo at both day 3 and day 7. At every assessed time point in the trial (daily in week 1 and average weekly scores through week 8), the serlopitant treated group demonstrated greater numerical improvement than the placebo group in both the WI-NRS 4-point responder analysis and in the mean change in WI-NRS from baseline.

About Psoriasis

Psoriasis is a common chronic autoimmune disorder of the skin, causing redness, irritation and scaly lesions. Approximately 12 million people in the United States have psoriasis, of which, according to the National Psoriasis Foundation, approximately 75% have mild psoriasis and 25% have moderate to severe psoriasis. According to market research conducted by Menlo, approximately 75% of psoriasis patients have moderate to severe pruritus.

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 covers three indications and includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a Phase 3-ready clinical program for the treatment of pruritus associated with psoriasis, and a Phase 2 clinical trial for the treatment of chronic pruritus of unknown origin. On November 11, 2019, Menlo announced that it had signed a definitive merger agreement with Foamix Pharmaceuticals Ltd. to create a combined biopharmaceutical company focused on the commercialization and development of therapeutics to serve patients in the dermatology space. For more information about Menlo Therapeutics and its proposed merger with Foamix, please visit Menlo’s website at www.menlotherapeutics.com.

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 the potential safety and efficacy of serlopitant for the treatment of various conditions, expectations with respect to the anticipated announcement of results of its clinical trials for pruritus associated with prurigo nodularis and chronic pruritus of unknown origin, and the timing of potential regulatory filings. 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 are unsuccessful, despite prior successfully completed clinical trials or do not demonstrate efficacy of serlopitant in the studied indications, the risk of adverse safety events, risks relating to the ongoing securities class action litigation, risks relating to the planned merger with Foamix Pharmaceuticals Ltd. and risks resulting from the unpredictability of the regulatory process and regulatory developments in the United States and foreign countries. These factors, together with those that are described in greater detail in Menlo Therapeutics’ Quarterly Report on Form 10-Q filed on October 31, 2019, in the Joint Proxy Statement/Prospectus on filed on January 6, 2020, 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.

Investor Contact: ir@menlotx.com