Menlo’s Setback Not Expected To Affect Results In Lead Pruritus Indication

With Foamix merger closing soon, Menlo’s serlopitant failed a Phase II trial in chronic pruritus of unknown origin, but the firm said a Phase III program in prurigo nodularis shouldn’t be affected. Its share in the new company is contingent on the PN data.

Winding curvy rural road with light trail from headlights leading through British countryside.
Disappointing data in one indication has Menlo looking ahead to Phase III PN readouts

Menlo Therapeutics Inc.'s oral serlopitant failed a Phase II trial in chronic pruritus of unknown origin on 26 February, but more important data readouts for the neurokinin receptor 1 (NK1) antagonist are coming in a few weeks. The dermatology firm’s equity in the pending merger with Foamix Pharmaceuticals Ltd.is based on the outcome of a pair of Phase III studies of serlopitant in pruritus (itch) associated with prurigo nodularis (PN).

Meno reported that in a 233-patient study testing serlopitant versus placebo in chronic pruritis of unknown origin (CPUO), an unmet medical need, serlopitant basically performed on a level basis with placebo for the primary endpoint of four-point or greater improvement in worst-itch numeric rating scale (WI-NRS) at 10 weeks compared to baseline. In the 116-patient treatment arm, 37.9% of patients achieved the endpoint, compared to 39

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