Clinical Data
Olumacostat Glasaretil Phase 2b Dose-Ranging Study in Acne Vulgaris

• In May 2016, Dermira reported topline results from the Phase 2b dose-ranging study evaluating the efficacy and safety of olumacostat glasaretil in patients with facial acne vulgaris compared to vehicle. 
   
• In the Phase 2b dose-ranging trial, 420 patients were randomized into five separate arms and instructed to apply olumacostat glasaretil at concentrations of 4.0% once daily (n=106), 7.5% once daily (n=110) or 7.5% twice daily (n=101), or to apply vehicle once or twice daily (n=53 and n=50, respectively), in all cases for 12 weeks.
   
• The primary endpoints were absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-point improvement from baseline in the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured at the end of the 12-week treatment period.
   
• Olumacostat glasaretil demonstrated statistically significant improvements from baseline to week 12 relative to the combined vehicle group in all primary efficacy endpoints at the highest dose of olumacostat glasaretil tested and in most primary endpoints at the two lower doses tested.
   
• Patients in the trial began to experience a reduction in inflammatory lesions with olumacostat glasaretil compared to vehicle at week 4 (-9.2, -8.6, -8.7 for olumacostat glasaretil 7.5% twice daily, 7.5% once daily and 4.0% once daily, respectively, vs. -7.2 for vehicle), which continued through week 8 (-12.3, -12.8, -12.3 vs. -9.7) and through to the end of the 12-week treatment period (-15.0, -14.5, -14.6 vs. -10.7).
   
• Reductions in non-inflammatory lesions with olumacostat glasaretil compared to vehicle were seen at week 4 (-8.6, -7.7, -8.3 for olumacostat glasaretil 7.5% twice daily, 7.5% once daily and 4.0% once daily, respectively, vs. -6.8 for vehicle), which continued through week 8 (-12.5, -11.9, -13.3 vs. -8.7) and through to the end of the 12-week treatment period (-17.5, -13.4, -15.3 vs. -9.3).

Consistent with an earlier Phase 2a study, olumacostat glasaretil was well-tolerated. Adverse events were primarily mild or moderate in severity. The most frequently reported adverse events across all three treatment groups were the common cold (nasopharyngitis), upper respiratory tract infection and application site itching (pruritus). No treatment-related serious adverse events were reported.Based on the results of the two Phase 2 trials, in December 2016 Dermira initiated a Phase 3 clinical program evaluating the safety and efficacy of olumacostat glasaretil in patients with facial acne vulgaris.