Menlo Therapeutics Inc. (NASDAQ: MNLO) a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus associated with various conditions, today announced top-line results from MTI-110 (TUSSIX), its Phase 2 clinical trial of serlopitant for the treatment of refractory chronic cough. In this 185 patient study, treatment with serlopitant failed to demonstrate benefit versus placebo on the primary and key secondary endpoints. In the primary endpoint analysis of change from baseline in 24-hour cough frequency after 12 weeks of treatment, the serlopitant group had 31% less reduction than the placebo group. In a key secondary analysis of response rates, 54% of placebo treated patients and 44% of serlopitant treated patients experienced a 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline. Serlopitant was well-tolerated in this study. Treatment related adverse events occurred at comparable rates in the serlopitant and placebo treated groups.
“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 Steve Basta, CEO of Menlo Therapeutics. “We are continuing the clinical development of serlopitant for pruritus associated with various conditions given the two successful Phase 2 clinical trials in which serlopitant demonstrated a reduction in chronic pruritus and pruritus associated with prurigo nodularis.”
Update on Serlopitant Clinical Development in Pruritus
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. Menlo Therapeutics has completed two Phase 2 studies with serlopitant showing a statistically significant reduction in pruritus compared to placebo. Originally developed by Merck and licensed to Menlo Therapeutics in 2012, serlopitant has been evaluated in approximately 1,500 patients and has been shown to be well-tolerated, including in patients who have received treatment for up to a year. Serlopitant is an investigational drug that is not currently approved for use in any indication.
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 associated with various conditions. The Company’s clinical development program for serlopitant includes ongoing Phase 3 studies for the treatment of pruritus associated with prurigo nodularis, an ongoing Phase 2 study for the treatment of pruritus associated with psoriasis, and a planned Phase 2 study for the treatment of chronic pruritus of unknown origin.