Results, Setbacks

Menlo’s solo pipeline drug suffers another ugly trial failure, done in by an outperforming placebo

Six months ago Menlo Therapeutics $MNLO saw its newly-public shares implode on a Phase II failure for its sole drug in pruritus. Today, the biotech took another torpedo right on the waterline as serlopitant also flopped in a Phase II study for chronic cough.

Once again the drug flunked the primary and key secondary endpoints, and Menlo is washing its hands of this particular indication after watching the placebo arm do better than the drug group. Here’s the problem in a nutshell:

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. 

Steve Basta, Menlo CEO

Menlo’s eggs are all in the serlopitant basket, which Merck handed over for a mere $1 million upfront. In this case the team at Menlo felt that the drug could be repurposed for persistent itch associated with dermatologic conditions such as atopic dermatitis, psoriasis and prurigo nodularis. At Merck this NK1 receptor antagonist was known as MK0594, which was put through a couple of trials for alcohol dependence (terminated) and overactive bladder.

You might think that the Redwood City, CA-based company would be wrapping it up on back-to-back failures, but that is definitely not the case here. Menlo has more pruritus data due out later this year, with the drug being studied in association with psoriasis. And researchers are recruiting two pivotal trials for pruritus associated with prurigo nodulari, with data due in H1 2020.

Menlo shares flatlined after dropping 70% back in the spring, with a host of investors bailing out on the news. On Monday, there was another retrenchment, as the stock plunged more than 20%.


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