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Menlo Therapeutics Announces Results from Two Phase 3

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Menlo Therapeutics Announces Results from Two Phase 3 Clinical Trials of Serlopitant for the Treatment of Pruritus Associated with Prurigo Nodularis
April 6, 2020 at 7:00 AM EDT
Conference call today at 8.30am EDT

BRIDGEWATER, N.J., April 06, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced top line results from two Phase 3 clinical trials evaluating the safety and efficacy of once daily oral serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis (PN), studies MTI-105 and MTI-106. Study MTI-105 enrolled 285 patients in the US and study MTI-106 enrolled a total of 295 patients from Germany, Poland and Austria. Patients were randomized 1:1 to either serlopitant 5mg or placebo treatment.

Study MTI-105 and Study MTI-106 did not meet their respective primary endpoint of demonstrating statistically significant reduction in pruritus in patients treated with serlopitant compared to placebo based upon a 4-point improvement responder analysis. In study MTI-105, 26.45% of patients in the serlopitant group achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 10 compared to baseline (primary efficacy endpoint) vs. 20.31% of patients treated with placebo (p=0.229). In study MTI-106, 25.90% of patients in the serlopitant group achieved a 4-point or greater improvement on the WI-NRS at week 10 compared to baseline (primary efficacy endpoint) vs. 18.95% of patients treated with placebo (p=0.158). Results for all supportive sensitivity analyses for the primary endpoint were comparable to the primary analyses for both studies.

“Menlo undertook a robust Phase 3 program to investigate serlopitant as a potential treatment for pruritis associated with PN. While the data showed a numerical advantage for serlopitant compared with placebo on the primary endpoint, the difference was not statistically significant,” said David Domzalski, Chief Executive Officer of Menlo Therapeutics Inc. “We will thoroughly analyze these data to better understand the outcome but, at this point, we do not intend to further pursue serlopitant. I would like to thank the patients and their families, as well as physicians and other healthcare professionals, who participated in these studies.”

“Despite this news, we remain focused on building a successful franchise in dermatology and leveraging our infrastructure to expand our pipeline,” added Mr. Domzalski. “We launched AMZEEQ as a treatment for moderate-to-severe acne at the beginning of the year and are very encouraged by positive reception so far from both physicians and patients. FMX103, which is our 1.5% minocycline foam for the treatment of papulopustular rosacea, is currently under review at the FDA and has been assigned a target PDUFA action date of June 2, 2020. If approved, this product will be our second commercial launch in 2020. Additionally, our Phase 2 study for FCD 105, our combination product containing minocycline plus the retinoid adapalene remains on track for the data readout later this quarter.”

On March 9, 2020, Menlo completed its merger transaction with Foamix Pharmaceuticals Ltd. (“Foamix”) pursuant to which Foamix became a wholly-owned subsidiary of Menlo. In the merger, Foamix shareholders received 0.5924 shares of Menlo common stock for each share of Foamix held at the closing, plus a contingent stock right (CSR) that would convert into additional shares of Menlo common stock if both results of the Phase 3 trials of serlopitant for pruritus associated with PN were not positive. In the case of mixed results where one trial was positive but the other trial was not, each CSR would convert into an additional 0.6815 shares of Menlo stock, such that the legacy Foamix shareholders would own approximately 76% of Menlo’s outstanding stock as of the closing. If both Phase 3 clinical trials were not positive, each CSR would convert into an additional 1.2082 shares of Menlo, such that the legacy Foamix shareholders would own approximately 82% of the outstanding Menlo shares as of the closing. If both results of the Phase 3 trials were positive, each CSR would automatically be terminated, and its holder would not be entitled to any additional shares of Menlo. The CSRs were not transferable and are payable only to the holders of Foamix shares at the closing of the merger.

If you were a shareholder of Foamix at the time of the closing, you will automatically receive for each Foamix share you held at the closing, an additional 1.2082 shares of Menlo common stock through your bank or broker plus cash in lieu of fractional shares and there is no need to take any further action. If you did not hold Foamix shares at the closing, you will not receive the additional merger consideration.

CSR and Exchange Agent
Shareholders with questions about their shares can contact our CSR and Exchange Agent, American Stock Transfer & Trust Company, LLC at (877) 248-6417.

About Studies MTI-105 and MTI-106
Studies MTI-105 and MTI-106 were identical Phase 3 multicenter, placebo-controlled double-blind clinical trials that enrolled patients with PN who experienced pruritus for at least six months prior to enrollment where the underlying cause for the pruritus was directly associated with PN. All patients reported a WI-NRS score of 7 or higher at screening and a minimum weekly average WI-NRS of 6.5 for each of two weeks prior to randomization. These trials compared treatment with serlopitant 5 mg orally once daily versus placebo for 10 weeks, with an additional post-treatment safety assessment period. For more information, refer to ClinicalTrials.gov Identifiers: NCT03546816 and NCT03677401.

Conference call details
There will be a conference call and webcast, at 8:30 a.m. Eastern Time today April 6th to discuss the top line Phase 3 results and provide a corporate update.
Toll free: 877-407-0784
International: 201-689-8560
Conference ID: 13701710

Webcast: http://public.viavid.com/index.php?id=139032

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