Menlo Therapeutics Granted Breakthrough Therapy Designation


Menlo Therapeutics Inc. recently announced the US FDA has granted Breakthrough Therapy Designation for serlopitant for the treatment of pruritus associated with prurigo nodularis (PN).

Breakthrough Therapy Designation is granted to expedite the development and review process for drugs intended to treat a serious condition where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies on a clinically significant endpoint.

“We are pleased that the FDA has granted Breakthrough Therapy Designation for serlopitant for the treatment of pruritus associated with PN. This designation is based upon data from our successful Phase 2 clinical trial in pruritus associated with PN and reflects the significant unmet need for treatment in this indication,” said Steve Basta, Chief Executive Officer of Menlo Therapeutics (Menlo). “Our two ongoing Phase 3 clinical trials in pruritus associated with PN, one being conducted in the US and the other in Europe, are enrolling well, and we look forward to working with the regulatory authorities with the goal of bringing this potential new treatment option to patients with prurigo nodularis.”

Menlo’s request for this designation was supported primarily by positive results from a Phase 2 clinical trial conducted in 127 patients with prurigo nodularis in which serlopitant met its primary and multiple secondary efficacy endpoints.  At week eight, for the primary efficacy analysis, the serlopitant 5-mg group showed a 36-mm improvement from baseline in average itch (measured by the itch visual analog scale) compared with a 19-mm improvement for the placebo group (p = 0.001).

Menlo is currently enrolling patients in two Phase 3 clinical trials (one in the US and one in Europe) to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected by the first quarter of 2020.

Serlopitant is a once-daily oral NK1 receptor antagonist being developed for the treatment of pruritus, or itch, associated with various conditions such as prurigo nodularis, psoriasis, and chronic pruritus of unknown origin.  Menlo has completed three positive Phase 2 clinical trials with serlopitant showing a statistically significant reduction in pruritus compared to placebo. Serlopitant has been evaluated in over 1,600 patients and has been shown to be well-tolerated, including in patients who have received treatment for up to 1 year. Serlopitant is an investigational drug that is not currently approved for use in any indication in any country.

Menlo Therapeutics Inc. is a late-stage biopharmaceutical company focused on the development of serlopitant, a once-daily oral NK1 receptor antagonist, for the treatment of pruritus. The company’s clinical development program for serlopitant includes two ongoing Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis, a planned Phase 3 program for the treatment of pruritus associated with psoriasis, and a Phase 2 clinical trial for the treatment of chronic pruritus of unknown origin.

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