Includes New Data Regarding Effects Observed at Week 4
MENLO PARK, Calif., Oct. 7, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the presentation of data for DRM01, a novel, topical sebum inhibitor in development for the treatment of acne. Topline data from the company's Phase 2a study showed that DRM01 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 today at the European Academy of Dermatology and Venereology (EADV) Congress 2015 being held October 7-11, 2015 in Copenhagen.
"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."
DRM01 Phase 2a Trial Design and Results
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.
DRM01 is a novel, topical, small-molecule sebum inhibitor in development for the treatment of acne. Sebum is an oily substance made up of lipids produced by glands in the skin called sebaceous glands, and excessive sebum production is an important aspect of acne that is not addressed by available topical therapies. DRM01 is designed to exert its effect by inhibiting acetyl coenzyme-A carboxylase, an enzyme that plays an important role in the synthesis of fatty acids, a type of lipid that represents an essential component of the majority of sebum lipids. Based on the results of a 108-patient, randomized, multi-center, double-blind, vehicle-controlled Phase 2a clinical trial, Dermira commenced a Phase 2b clinical program in April 2015 and expects topline results from the Phase 2b clinical program in the first half of 2016.
Dermira is a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients. Dermira's portfolio of five product candidates targets significant market opportunities and includes three late-stage product candidates: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe plaque psoriasis; DRM04, in Phase 3 development for the treatment of axillary hyperhidrosis; and DRM01, in Phase 2b development for the treatment of acne. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including with respect to the DRM01 mechanism of action, the interpretation of the Phase 2a clinical results, enrollment of the Phase 2b clinical trial and when results from the DRM01 Phase 2b clinical program will be available. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the outcomes of our clinical trials, our dependence on third-party clinical research organizations, manufacturers and suppliers, regulatory compliance with respect to the design and implementation of our clinical trials, our ability to obtain regulatory approval for our product candidates, and our ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled "Risk Factors" set forth in Dermira's Annual Report on Form 10-K, Dermira's Quarterly Report on Form 10-Q and other filings Dermira makes with the Securities and Exchange Commission from time to time for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. We undertake no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
CONTACT: Dermira Contact
Chief Operating Officer and Chief Financial Officer
Robert H. Uhl