Results expected in Q1 2020
REDWOOD CITY, Calif., Sept. 24, 2019 (GLOBE NEWSWIRE) — Menlo Therapeutics Inc. (Nasdaq: MNLO), a late-stage biopharmaceutical company, today announced that it has completed patient enrollment in its Phase 2 clinical trial evaluating the safety and efficacy of once daily oral serlopitant for the treatment of Chronic Pruritus (itch) of Unknown Origin (CPUO). The Phase 2 trial is designed to evaluate reduction in pruritus with serlopitant compared to placebo over a ten-week treatment period based upon a 4-point responder analysis on the worst-itch numeric rating scale (WI-NRS), which is a standard measure of itch. CPUO is a condition in which patients suffer from itch, often for years, without any identified medical condition as a cause for the itch. This condition may affect approximately two million patients in the U.S., with no therapy approved or indicated to treat these patients.
“The rapid enrollment in this trial reflects the high unmet need in the CPUO patient population,” said Steve Basta, chief executive officer of Menlo Therapeutics. “We had targeted enrolling 200 patients in approximately one year. We were able to enroll 233 patients in approximately nine months, reflecting the significant motivation of these patients to seek treatment for this condition. CPUO is one of three pruritus indications we are currently pursuing with our novel, highly selective small molecule NK1 receptor antagonist, including our ongoing Phase 3 Prurigo Nodularis (PN) and Phase 3-ready Psoriasis pruritus programs.”
Menlo Therapeutics expects to report the results of the CPUO trial in the first quarter of 2020, and results from two PN Phase 3 trials in the first half of 2020. If the PN trials are successful, Menlo is preparing to submit an NDA for pruritus associated with PN late 2020.
Menlo Therapeutics began enrolling patients in the multicenter, placebo‑controlled double‑blind Phase 2 clinical trial in CPUO in the first quarter of 2019. The trial is being conducted at 36 sites in the United States and has enrolled 233 patients who have experienced pruritus for at least six months prior to enrollment with no identified underlying cause for the pruritus. This trial is comparing treatment with serlopitant versus placebo for ten-weeks, with patients followed for a further five-week post-treatment.
About Chronic Pruritus of Unknown Origin
CPUO is typically defined as pruritus lasting 6 weeks or longer, where the underlying cause is unclear. It is also sometimes referred to as idiopathic pruritus or pruritus of undetermined origin. This condition disproportionately affects the elderly. No therapy has been previously developed to treat pruritus in these patients, despite the significant unmet need for such treatment and the notable prevalence of this condition. Menlo Therapeutics’s market research indicates approximately two million patients may have CPUO in the U.S. Menlo believes if serlopitant is successfully developed for this indication, it may be the first therapy available to treat pruritus in these patients.
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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