REDWOOD CITY, Calif., [October 11, 2019] — 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 pruritus in patients with psoriasis in an oral presentation at the 28th Congress of the European Academy of Dermatology and Venereology held in Madrid. The results demonstrated a statistically significant reduction in pruritus (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. Pruritus 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 pruritus 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
The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled clinical trial which evaluated the efficacy, safety, and tolerability of serlopitant for the treatment of pruritus associated with psoriasis. The trial enrolled patients between 18 and 80 years of age with the diagnosis of plaque psoriasis for at least 6 months prior to randomization and with plaques covering ≤ 10% body surface area. In addition, patients had pruritus of at least 4 weeks duration prior to screening and a WI-NRS score consistent with severe pruritus at screening. Patients were randomized 1:1 to receive either serlopitant 5 mg or placebo orally once daily and were not allowed to use any other psoriasis therapy, other than bland emollients, for the duration of the trial. The primary efficacy endpoint was a responder analysis of the proportion of patients in each group achieving a 4-point WI-NRS improvement at week 8 compared to baseline. As a randomized Phase 2 trial, the pre-defined statistical threshold for significance was a p-value of < 0.05 (one-sided test).
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.
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.
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.
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