A Menlo Therapeutics drug developed to treat chronic cough has failed to beat a placebo in a mid-stage study, and the clinical-stage company is stopping work on that drug program.
It’s the second time in six months that the drug, serlopitant, has failed in clinical trials. In April, Redwood City, CA-based Menlo (NASDAQ: MNLO) announced that the drug failed a mid-stage study testing the drug as a treatment for the itching associated with atopic dermatitis. That failure sank Menlo’s shares by 72 percent. On Monday, Menlo’s stock price fell more than 22 percent to $7.88 per share. Menlo’s shares were priced at $17 each when the company went public in January.
The main goal of the 185-patient Phase 2 study in chronic cough was a reduction in cough frequency over a 24-hour period. After 12 weeks of treatment, Menlo said that patients treated with its drug showed a reduction in cough frequency that was 31 percent less than what was observed in the placebo group. On the secondary measure of response rates, Menlo said that 44 percent of patients treated with its pill drug experienced a 30 percent or greater reduction in 24-hour cough frequency. In the placebo group, 54 percent of patients experienced that level of reduction.
Though Menlo is stopping work on serlopitant in chronic cough, the company is holding out hope that the drug could treat other conditions. Data from another Phase 2 study, testing the drug as a treatment for the itching associated with psoriasis, are expected in December. Menlo is also enrolling two Phase 3 studies testing the drug as a treatment for the itching associated with prurigo nodularis, a rare disorder characterized by the formation of itchy lumps on the skin that can cause patients to scratch themselves to the point of bleeding. Those studies are expected to yield data in the first half of 2020.
Menlo is planning yet another mid-stage clinical trial for the drug. A Phase 2 study in chronic itching of unknown origin is slated to start this year. The company expects to report results in the first half of 2020.
Photo by Depositphotos