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Menlo (MNLO) Completes Enrollment in Phase II Pruritus Study

Zacks Equity Research

Menlo Therapeutics Inc. MNLO announced that it has completed patient enrollment in its phase II study evaluating the safety and efficacy of once-daily oral serlopitant for the treatment of chronic pruritus (itch) of unknown origin (CPUO). 

The phase II study is designed to evaluate the reduction in pruritus with serlopitant compared to placebo over a ten-week treatment period based on a 4-point responder analysis on the worst-itch numeric rating scale (WI-NRS), which is a standard measure of itch. The study enrolled 233 patients, who experienced pruritus for at least six months prior to enrollment with no identified underlying cause for the pruritus.

Serlopitant, a small molecule, highly selective neurokinin 1 (NK-1) receptor antagonist, is being developed for the treatment of prurigo nodularis (PN), psoriasis and CPUO.

Shares of the company have gained 12.6% so far this year against the industry’s decline of 3.2%.

 

The company has completed four double-blind phase II studies in more than 1,000 patients with pruritus and observed clinically relevant and statistically significant improvements in pruritus in patients treated with serlopitant compared to patients treated with placebo in three of the four studies.

Menlo is also enrolling patients in two phase III studies, which will evaluate the candidate in patients with pruritus associated with PN in the United States and Europe. Data from the study is anticipated in the first half of 2020.

The successful development of serlopitant in these ongoing studies is critical for Menlo’s growth prospects. The company had in-licensed serlopitant from Merck MRK in 2012.

There are several pharma companies developing treatments for pruritus. Vanda Pharmaceuticals Inc.’s VNDA Tradipitant (VLY-686), a small molecule neurokinin-1 receptor antagonist, is presently in clinical development for the treatment of chronic pruritus in atopic dermatitis, gastroparesis and motion sickness.

Zacks Rank & A Stock to Consider

Currently, Menlo is a Zacks Rank #3 (Hold) stock.

A better-ranked stock in the biotech sector is Acorda Therapeutics Inc. ACOR, carrying a Zacks Rank #1 (Strong Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates for the current year narrowed from $3.51 to $2.74 over the past 60 days. The company recorded a positive earnings surprise in the preceding four quarters, the average beat being 69.68%.    

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