Pharmaceutical company Menlo Therapeutics' serlopitant has met the primary and secondary endpoints in the Phase II clinical trial (TCP-102) for the treatment of pruritus associated with prurigo nodularis.
Serlopitant is an investigational, small-molecule, highly potent and selective NK1-R antagonist.
The results showed that serlopitant has statistically reduced pruritus when compared with placebo.
The multi-centre, randomised, placebo-controlled Phase II trial has evaluated once-daily, orally administered, serlopitant 5mg tablets for eight weeks in 127 patients at 15 clinical study sites in Germany.
It was observed that at eight weeks, there was a 48% reduction in average pruritus in case of serlopitant-treated patients, while patients administered with placebo showed a 26% reduction.
At every evaluation timepoint of two, four, and eight weeks, a statistically significant greater reduction of pruritus was found in the serlopitant group when compared to the control group.
The trial's additional measures of itch also confirmed the data of decreased pruritus in serlopitant-treated subjects versus the placebo group.
Serlopitant was found to be well tolerated in the trial and showed an overall safety profile, with observed adverse events being mild-to-moderate.
The Phase II trial's safety and efficiacy results are consistent with results from a previous Phase II trial (TCP-101), which was conducted in 257 subjects with chronic pruritus, at 25 sites in the US.
Serlopitant was originally developed by Merck and licensed to Menlo Therapeutics in 2012. It has been assessed in more than 1,000 human clinical trial subjects in 13 Phase I and four Phase II studies.