Menlo Therapeutics' serlopitant comes up short in chronic cough

Steve Basta, CEO Menlo Therapeutics
In 2012, Merck licensed serlopitant to Menlo to develop it in indications other than nausea and vomiting. (Menlo Therapeutics)

Menlo Therapeutics started the year with a $119 million IPO, priced at the top end of its range, but the biotech can’t seem to catch a break. Just six months after its lead drug flunked a phase 2 trial in atopic dermatitis, Menlo is reporting another fail—this time in chronic cough.

Topline data from a 185-patient study show the drug, serlopitant, did not meet its primary and secondary endpoints. After 12 weeks, the drug performed worse than placebo at reducing patients’ 24-hour cough frequency.

“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,” said Menlo CEO Steve Basta, in a statement.

Serlopitant is the only drug in Menlo’s pipeline. It licensed the NK-1 receptor antagonist from Merck in 2012 and is developing it for various causes of pruritus, or skin itch, as well as for chronic cough. In its S-1, Menlo said it was eyeing NDAs for up to three indications in 2020: pruritus associated with atopic dermatitis, psoriasis and prurigo nodularis. It has since dumped its atopic dermatitis program but has pinned its hopes on the remaining two indications.

“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,” Basta said.

Menlo started its phase 3 program in prurigo nodularis this year and expects to report phase 2 data from its psoriasis program in December or January.

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