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Menlo Therapeutics Presents Successful Phase 2 Clinical Trial Results of Serlopitant in Psoriasis at the European Academy of Dermatology and Venereology MeetingREDWOOD CITY, Calif., Oct. 11, 2019 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO), a late-stage biopharmaceutical company, presented results from its successful Phase 2 clinical trial of serlopitant for the treatment of pruritis in patients with psoriasis in an oral presentation at the 28th Congress of the European Academy of Dermatology and Venereology held in Madrid yesterday. The results demonstrated a statistically significant reduction in pruritis (itch) in patients treated with serlopitant, compared to placebo, and further demonstrated consistent benefit favoring serlopitant when evaluating response rates across patient demographic categories assessed in this study. Pruritis is reported by patients to be one of the most severe and troublesome symptoms of psoriasis. “The statistically significant Phase 2 clinical trial results in psoriasis patients is further evidence of the potential of serlopitant to significantly reduce pruritus (itch),” said Steve Basta, chief executive officer of Menlo Therapeutics. “In addition to our psoriasis program, we are making strong progress in our Phase 3 trials of serlopitant in prurigo nodularis as well as the Phase 2 trial in chronic pruritis of unknown origin and look forward to additional late stage data from serlopitant trials in early 2020.” The psoriasis trial reported at EADV successfully met its primary endpoint, showing a statistically significant reduction in pruritus based upon a 4-point improvement responder analysis. In the trial, 33% of patients treated with serlopitant 5 mg daily achieved a 4-point or greater improvement on the worst-itch numeric rating scale, or WI-NRS, at week 8 compared to baseline vs. 21% of patients treated with placebo (primary efficacy endpoint, p= 0.028). Additionally, the 4-point responder rate at week 8 was higher in serlopitant-treated patients than in patients in the placebo group when evaluating groups segmented by baseline characteristics: age, gender, weight, percentage of body surface area affected by psoriasis lesions, itch severity, or severity of psoriasis. Serlopitant was well-tolerated in this clinical trial. No serious adverse events were reported for serlopitant-treated patients. Treatment-emergent adverse events assessed as likely related to treatment were observed with similar frequency in both groups (4.0% for placebo and 4.9% for serlopitant). No serious adverse events were observed in patients treated with serlopitant. About the Phase 2 Clinical Trial of Serlopitant in Psoriasis About Psoriasis About Serlopitant 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, psoriasis, and chronic pruritus of unknown origin, 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. Investor Contact: [email protected] |