Menlo Therapeutics Announces Completion of Enrollment in Two Phase 3 Trials of Serlopitant in Prurigo Nodularis

Menlo Therapeutics Inc. (Nasdaq: MNLO), a late-stage biopharmaceutical company, today announced that it has completed enrollment of patients in its two Phase 3 clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus associated with prurigo nodularis (PN). The U.S. and European Phase 3 trials enrolled 285 and 295 patients, respectively.  The Phase 3 trials are designed to evaluate reduction in pruritus in patients treated with serlopitant compared to placebo over a ten-week treatment period.  The primary endpoint in these studies will compare the number of treated vs. control patients who experience a 4-point improvement on the worst-itch numeric rating scale (WI-NRS), which is a standard measure of itch.  Serlopitant has received Breakthrough Therapy Designation by the FDA for the treatment of pruritus associated with PN, a severely itchy skin disease characterized by multiple, firm, itchy nodules on the skin. Currently, there is no therapy approved or indicated to treat the estimated 500,000-1,000,000 PN patients in the U.S.

“During 2019, Menlo has made solid progress on our clinical program and NDA preparations for serlopitant.  Our primary focus has been our two Phase 3 trials in PN, our anticipated initial NDA indication,” said Steve Basta, Chief Executive Officer of Menlo Therapeutics.  “We are pleased with how quickly and efficiently these Phase 3 trials enrolled and with our recently announced success enrolling our Phase 2 trial in CPUO.  We look forward to key data on both programs in early 2020.”

Menlo Therapeutics expects to report the results of the PN trials in March or April of 2020.  If the PN trials are successful, Menlo plans to submit an NDA for pruritus associated with PN in the second half of 2020.   

Both PN Phase 3 trials are multi-center, randomized, double-blind, placebo‑controlled trials evaluating treatment with 5 mg serlopitant daily for ten weeks and its ability to reduce pruritus associated with PN compared with placebo. Menlo has enrolled 285 patients at 46 sites in the US trial and has enrolled 295 patients at 39 sites in in the European trial. The trials enrolled patients with a WI‑NRS of at least seven at screening. The primary efficacy analysis for both trials is a 4‑point responder rate in the WI‑NRS at ten weeks.

A live audio webcast of today’s Investor Day will be available to the public on the Investor Relations section of the company's website at http://ir.menlotherapeutics.com/.

An archived replay will be available for approximately 90 days following the event at the same link.

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 500,000 – 1,000,000 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, or may have an unknown cause.

About Serlopitant

Serlopitant is a small molecule, highly selective NK1 receptor antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, the neurokinin-1 receptor, or NK1 receptor. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1 receptor has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.

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.

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, the stages of various programs, the timing of potential regulatory filings, the regulatory process and regulatory approvals, and the possible size of patient populations for various conditions and potential indications. 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 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, risks relating to ongoing securities class action litigation, 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’ Quarterly Report on Form 10-Q to filed on August 1, 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.

For more information about Menlo Therapeutics, please visit our website at www.menlotherapeutics.com.

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