Olumacostat glasaretil was evaluated for its efficacy and safety in comparison to vehicle to support Dermira’s plans to submit a new drug application to the US Food & Drug Administration (FDA).
The co-primary endpoints of the two late-stage trials were the absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the percentage of patients showing at least a two-grade improvement from baseline to a final grade of zero or one on the five-point Investigator’s Global Assessment (IGA) scale.
Each endpoint was evaluated on the patients’ face at the end of the treatment period which lasted 12 weeks, following which Dermira found out that the co-primary endpoint results were not statistically significant.
Held across 94 sites in the US, Canada and Australia, the trials had patients randomized in a 2:1 ratio to be treated with either olumacostat glasaretil at a concentration of 5% or vehicle, daily twice.
Dermira chief development officer Luis Peña said that the company is analyzing the results of the two phase 3 trials, and is expected not to pursue the development of olumacostat glasaretil based on the data collected till date.
Dermira chairman and CEO Tom Wiggans said: “We remain dedicated to bringing new treatments to people living with chronic, underserved skin conditions.
“As we look ahead, we are focused on building a commercial organization to support the anticipated launch of glycopyrronium tosylate for axillary hyperhidrosis later this year, subject to FDA approval, as well as our Phase 2b trial evaluating lebrikizumab as a potential treatment for moderate-to-severe atopic dermatitis, for which we expect to announce topline data in the first half of 2019.”
Image: Dermira’s olumacostat glasaretil failed to meet co-primary endpoints in two phase 3 trials. Photo: courtesy of jk1991/FreeDigitalPhotos.net.