Menlo Therapeutics Announces Results from a Phase 2 Clinical Trial of Serlopitant for the Treatment of Refractory Chronic Cough
Serlopitant fails to demonstrate efficacy relative to placebo on primary and secondary endpoints
“Based upon the results of this trial, we do not anticipate further development of serlopitant for the treatment of refractory chronic cough. We sincerely thank the patients and investigators who participated in this trial,” stated
- The Phase 2 clinical trial of serlopitant to treat pruritus associated with psoriasis is fully enrolled, and data is expected in December 2018.
- We are currently enrolling patients in two Phase 3 clinical trials (one in the U.S. and one in
Europe) to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected in the first half of 2020.
- We plan to initiate a Phase 2 clinical trial in patients with chronic pruritus of unknown origin this year and expect results in the first half of 2020.
Serlopitant is a once-daily NK1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with various conditions.
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 timing of data related to the Phase 2 clinical trial of serlopitant to treat pruritus associated with psoriasis, the conduct of the two active Phase 3 clinical trials for pruritus associated with prurigo nodularis and the conduct of an anticipated Phase 2 trial in patients with chronic pruritus of unknown origin. 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.
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Source: Menlo Therapeutics Inc.