Menlo Therapeutics Begins European Prurigo Nodularis Phase 3 Trial and Presents Additional Data from PN Phase 2 Trial at EADV

September 17, 2018

REDWOOD CITY, Calif., Sept. 17, 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 conditions and for refractory chronic cough, today announced it has initiated enrollment in the second of two Phase 3 trials of serlopitant for the treatment of pruritus with prurigo nodularis (PN). This second PN Phase 3 trial is being conducted in Europe.

In May, Menlo began enrollment in the first of the two PN Phase 3 trials which is being conducted in the U.S. The U.S. PN Phase 3 trial is more than 20% enrolled.

Both PN Phase 3 trials are multi-center, randomized, double-blind, placebo‑controlled trials intended to evaluate if treatment with 5 mg serlopitant daily for ten weeks can reduce pruritus associated with PN compared with placebo. Menlo expects to enroll 200 patients at approximately 50 sites in each trial. The trials are enrolling patients with a worst‑itch NRS score, or WI‑NRS, of at least seven at screening. The primary efficacy analysis for both of these trials is a four‑point responder rate in the WI‑NRS at ten weeks. Results from both trials are expected in the first half of 2020.

Completed Phase 2 Clinical Trial of Serlopitant in Patients with PN

The Phase 2 clinical trial of serlopitant in patients with PN was completed in June 2016. The study was a multi-center, randomized, double‑blind, placebo‑controlled study in 127 adult patients. As previously reported, the study met its primary and multiple secondary efficacy endpoints of pruritus reduction in patients in the serlopitant-treatment group compared with placebo. For the primary efficacy analysis defined as change from baseline in average itch VAS at weeks four and eight, a serlopitant dose of 5 mg given once a day led to a superior change from baseline in average itch VAS than placebo. At week four, the serlopitant 5 mg group showed a 25 mm improvement from baseline in average itch VAS compared to a 15 mm improvement from baseline in the placebo group (p = 0.025), and at week eight, the serlopitant 5 mg group showed an improvement of 36 mm from baseline in average itch VAS compared with an improvement of 19 mm for the placebo group (p = 0.001). Patients receiving 5 mg serlopitant had a statistically significant reduction in the average itch VAS score for pruritus compared to the placebo group at every measured time point.

Serlopitant has been dosed in approximately 1,400 individuals and has been shown to be well‑tolerated, including when administered to patients in a clinical trial for up to one year.

New Exploratory Analysis of Additional Data from the Phase 2 Clinical Trial of Serlopitant in PN Presented at the European Academy of Dermatology and Venereology (EADV) Congress on September 15th, 2018

A recent exploratory analysis of results from a qualitative Verbal Rating Scale (VRS) survey instrument given to patients throughout the completed Phase 2 clinical trial of serlopitant in patients with PN was presented by Sonja Ständer, M.D., Center for Chronic Pruritus, Department of Dermatology, University Hospital Münster, Münster, Germany at the EADV Congress in Paris, France on Saturday, September 15th. The presentation was based on a retrospective analysis of the qualitative survey instrument administered to patients as part of this Phase 2 clinical trial. The objective of the analysis was to assess the impact of treatment on sensory sensations of PN experienced by the patients.

The VRS survey asked patients with respect to pruritus, burning, and stinging whether such sensations were either not present, mild, moderate, severe, or very severe. As this was a retrospective assessment of these data, only descriptive statistical analyses were conducted. The patient-reported VRS scores indicate greater improvement in itching, burning and stinging for serlopitant treated patients as compared to placebo treated patients.

Characteristic Baseline After 8 Weeks of Treatment --------------- --------------------- -------------------------- Placebo- Serlopitant- Placebo- Serlopitant- Treated Treated Treated Treated Patients Patients Patients Patients (n=63) (n=64) (n=63) (n=64) --------------- -------- ------------ -------- ----------------- Patients with Moderate, 96.8% 100% 71.1% 45.6% Severe or Very Severe Pruritus --------------- ----- -- ----- ------ ----- -- ----- ----------- Patients with Moderate, 64.5% 59.4% 53.5% 26.8% Severe or Very Severe Burning --------------- ----- -- ----- ------ ----- -- ----- ----------- Patients with Moderate, 45.0% 45.0% 39.5% 22.2% Severe or Very Severe Stinging --------------- ----- -- ----- ------ ----- -- ----- -----------

“Limited data are available about disease characteristics for patients with prurigo nodularis. The Phase 2 trial of serlopitant was one of the largest randomized controlled trials conducted to date in this patient population, and we wanted to conduct a retrospective analysis to better understand the sensory experience of patients with PN and the impact of treatment on these sensations,” said Dr. Sonja Ständer. “The most common descriptions of pruritus reported by these patients at baseline were itching, combined with pain-related sensations such as burning and stinging. In this retrospective analysis, we observed improvement in some of the most common pruritus characteristics reported by the patients in this study when treated with serlopitant for eight weeks.”

About Serlopitant

Serlopitant is a once-daily NK1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with various conditions. 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 approximately 1,400 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 Prurigo Nodularis

We estimate that there are approximately 350,000 people with prurigo nodularis in the United States. Prurigo nodularis is a 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. 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. No treatment for prurigo nodularis has been approved in the United States or Europe.

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 conditions and for refractory chronic cough. The Company’s clinical development program for serlopitant includes ongoing and planned Phase 3 studies for the treatment of pruritus associated with prurigo nodularis, ongoing Phase 2 studies for the treatment of pruritus associated with psoriasis and refractory chronic cough, and a planned Phase 2 study 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 expectations about the conduct of a Phase 3 clinical trial in the United States for pruritus associated with prurigo nodularis and a Phase 3 clinical trial in Europe for pruritus associated with prurigo nodularis. 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 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 that Menlo Therapeutics will need to raise additional capital and will be unable to do so on favorable terms or at all, risks of competition and the risk that Menlo Therapeutics is not able to successfully defend or protect its intellectual property. These factors, together with those that are described in greater detail in Menlo Therapeutics Annual Report on Form 10-K filed on March 28, 2018 and its Quarterly Report on Form 10-Q filed on August 1, 2018, 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: dsheel@menlotx.com

Media Contact: media@menlotx.com

Update hourly