Menlo Therapeutics’ Serlopitant Granted Breakthrough Therapy Designation by FDA for the Treatment of Pruritus Associated with Prurigo Nodularis

January 15, 2019 at 8:30 AM EST

REDWOOD CITY, Calif., Jan. 15, 2019 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ: MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with prurigo nodularis (PN). 

Breakthrough Therapy designation is granted to expedite the development and review process for drugs intended to treat a serious condition where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies on a clinically significant endpoint. 

“We are pleased that the FDA has granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with PN.  This designation is based upon data from our successful Phase 2 clinical trial in pruritus associated with PN and reflects the significant unmet need for treatment in this indication,” said Steve Basta, Chief Executive Officer of Menlo Therapeutics (Menlo).  “Our two ongoing Phase 3 clinical trials in pruritus associated with PN, one being conducted in the U.S. and the other in Europe, are enrolling well, and we look forward to working with the regulatory authorities with the goal of bringing this potential new treatment option to patients with prurigo nodularis.” 

Menlo’s request for this designation was supported primarily by positive results from a Phase 2 clinical trial conducted in 127 patients with prurigo nodularis in which serlopitant met its primary and multiple secondary efficacy endpoints.  At week eight, for the primary efficacy analysis, the serlopitant 5 mg group showed a 36 mm improvement from baseline in average itch (measured by the itch visual analog scale) compared with a 19 mm improvement for the placebo group (p = 0.001).  

Menlo is 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 by the first quarter of 2020. 

About Serlopitant

Serlopitant is a once-daily oral NK1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with various conditions such as prurigo nodularis, psoriasis and chronic pruritus of unknown origin.  Menlo has completed three positive Phase 2 clinical trials with serlopitant showing a statistically significant reduction in pruritus compared to placebo.  Serlopitant has been evaluated in over 1,600 patients and has been shown to be well-tolerated, including in patients who have received treatment for up to one year.  Serlopitant is an investigational drug that is not currently approved for use in any indication in any country.

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 includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a planned Phase 3 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 expectations about the Company’s ability to develop and advance product candidates into and successfully complete clinical trials within the anticipated timeframe and to gain regulatory approval to market its product candidates. 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 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 November 7, 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.

Media Contact: media@menlotx.com

Investor Contact: dsheel@menlotx.com

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Source: Menlo Therapeutics Inc.