Dermira Presents Clinical Data for DRM01 Acne Program

Dermira, Inc. presented clinical data from its DRM01 Phase 2a trial in patients with facial acne vulgaris. The primary endpoints in this trial, the changes from baseline in inflammatory and non-inflammatory lesion counts and an improvement in the Investigator's Global Assessment (IGA) of acne, were met with statistical significance. DRM01 was generally well tolerated with no reported serious treatment-related adverse events. These results were presented during the Late-Breaking Research in Dermatology Forums at the American Academy of Dermatology (AAD) Annual Meeting on March 20, 2015 in San Francisco. This was the first presentation of DRM01 data at a medical meeting. 

"We were excited to share Dermira's positive Phase 2a results for DRM01 at the largest and highest profile meeting for the dermatology community," stated Tom Wiggans, chairman and chief executive officer of Dermira. "The results we observed from this study are compelling, and we look forward to advancing the program. Our next steps include the initiation of a dose-finding Phase 2b clinical study with DRM01, which we expect will be underway very soon." 

"The favorable results for DRM01 demonstrated a significant improvement in patients with moderate to severe acne across all primary endpoints," stated Dr. Robert Bissonnette of Innovaderm Research, Inc., principal investigator for the study. "Patients and physicians have a strong need for novel and effective treatments for the growing number of people with acne vulgaris, a condition that can have profound effects on emotional well-being and social interactions." 

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). 

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.