Menlo Therapeutics Inc. (NASDAQ:MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced the publication of the company’s Phase 2 trial of serlopitant for the treatment of pruritus associated with psoriasis in the Journal of the American Academy of Dermatology (JAAD).
The trial results were published in the February 3, 2020, online JAAD and demonstrate that serlopitant significantly reduced pruritus in patients with psoriasis and was well-tolerated. The trial successfully met its primary endpoint, showing a statistically significant reduction in pruritus compared to placebo at week 8 based upon a 4-point improvement responder analysis. The trial results were previously presented at the European Academy of Dermatology and Venereology Meeting last year.
“We are pleased with the growing body of evidence that supports the activity of serlopitant to treat pruritus in multiple indications,” said Steve Basta, chief executive officer of Menlo Therapeutics. “We look forward to upcoming results from our Phase 2 trial of serlopitant in chronic pruritus of unknown origin expected in late-February and our Phase 3 trials for the treatment of pruritus associated with prurigo nodularis expected in March or April. We thank the patients and investigators involved in this study for their dedication and contributions to advancing development of serlopitant for treatment for pruritus associated with psoriasis.”
In this randomized, double-blind, placebo-controlled study, 204 patients with psoriasis received 5 mg serlopitant or placebo orally once daily for 8 weeks. For the primary endpoint assessment, pruritus scores were measured using the worst-itch numeric responder scale (WI-NRS). The study met its primary endpoint, with 33.3% of patients treated with serlopitant achieving a 4-point improvement from baseline on the WI-NRS at week 8 compared with 21.1% of placebo recipients (P=0.028). In addition, the study met a key secondary endpoint, with 20.8% of patients treated with serlopitant achieving a 4-point improvement from baseline on the WI-NRS at week 4 vs 11.5% of placebo recipients (P=0.039). Other key secondary endpoints were the mean absolute change in WI-NRS from baseline to day 3 and day 7, which were numerically greater for serlopitant than placebo at both day 3 and day 7. At every assessed time point in the trial (daily in week 1 and average weekly scores through week 8), the serlopitant treated group demonstrated greater numerical improvement than the placebo group in both the WI-NRS 4-point responder analysis and in the mean change in WI-NRS from baseline.