Topline data from a Phase 2a study showed that Dermira’s DRM01, a novel topical sebum inhibitor in development for the treatment of acne, met all of the primary efficacy endpoints, demonstrating statistically significant improvements relative to vehicle in the reduction of lesion counts and the proportion of patients who achieved a successful improvement in Investigator's Global Assessment (IGA) score at week 12. In addition, newly presented data suggest that a treatment difference in these endpoints was observed as early as the first efficacy assessment, which was conducted after four weeks of the 12-week treatment period. As previously reported, topical treatment with DRM01 was generally well tolerated. These results were presented at the European Academy of Dermatology and Venereology (EADV) Congress 2015, held October 7-11, 2015 in Copenhagen.

This Phase 2a clinical trial was a randomized, multi-center, double-blind, vehicle-controlled study that enrolled 108 patients with moderate or severe acne. Inclusion criteria required a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions and an IGA score of three or greater on a five-point scale that ranges from a score of zero, representing clear skin, to a score of four, representing severe disease. Patients were instructed to apply either DRM01 at a concentration of 7.5% or vehicle to the face twice daily for 12 weeks. A total of 53 subjects were randomized to receive DRM01, and the other 55 were randomized to receive vehicle only. The primary efficacy endpoints used in this trial consisted of absolute changes from baseline to week 12 in the numbers of inflammatory and non-inflammatory lesions and the proportion of patients with at least a two-grade improvement from baseline to week 12 in IGA score.

DRM01 demonstrated statistically significant improvements from baseline to week 12 relative to vehicle in all primary efficacy endpoints. The number of inflammatory lesions in patients treated with DRM01 was reduced by an average of 19.3 compared to 13.3 in patients who received the vehicle only (p=0.0003), or an average percentage reduction of 63.9% and 45.9%, respectively (p=0.0006). The number of non-inflammatory lesions in patients treated with DRM01 was reduced by an average of 19.9 compared to 11.2 in patients who received the vehicle only (p=0.0032), or an average percentage reduction of 48.1% and 28.8%, respectively (p=0.0025). At the end of the 12-week treatment period, 24.5% of patients (13/53) who received DRM01 achieved a successful improvement in the IGA score (minimum two-grade improvement), in comparison with 7.3% of patients (4/55) who received the vehicle only (p=0.0070).

At week 4, the first efficacy assessment time point, subjects in the DRM01 group achieved numerically greater reductions from baseline in inflammatory and non-inflammatory lesion counts than subjects in the vehicle group (p=0.0666 and p=0.0328, respectively). In addition, the proportion of subjects who achieved a ≥ 2-grade improvement in IGA score was numerically greater in the DRM01 group than in the vehicle group (p=0.1591).

DRM01 was well-tolerated with adverse events mild or moderate in severity. The most frequently reported adverse event was nasopharyngitis, which was reported in 13 (24.5%) of the patients treated with DRM01 and in 7 (12.7%) of the patients who received vehicle and which was considered unrelated to treatment. Application-site conditions, which are frequently observed in most clinical trials of topical products, also were observed. No treatment-related serious adverse events were reported.

"We are excited to share these data from our DRM01 Phase 2a clinical trial," stated Tom Wiggans, chairman and chief executive officer of Dermira. "The new data point to a potential treatment effect as early as week 4 and support the previously reported data, which showed that the trial demonstrated clinically meaningful and statistically significant improvements in patients with moderate-to-severe acne across all primary efficacy endpoints. We continue to expect to announce topline data from our ongoing DRM01 Phase 2b study during the first half of 2016 based on current and projected rates of patient enrollment."