- Safety and Efficacy Data Confirm Results from Previous Phase 2a Trial
- DRM01 Phase 3 Clinical Program Planning Underway
- Management to Host Webcast and Conference Call Today at 5:30 a.m. PT / 8:30 a.m. ET
MENLO PARK, Calif., May 10, 2016 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced topline results from its Phase 2b dose-ranging study for DRM01 in patients with facial acne vulgaris. DRM01 is a novel, small molecule designed to inhibit sebum production following topical application. The clinical study evaluated the safety and efficacy of DRM01 and demonstrated statistically significant improvements in all primary endpoints compared to vehicle at the highest dose and in most primary endpoints at the two lower doses. DRM01 was well-tolerated with adverse events primarily mild or moderate in severity.
Based on these results, Dermira plans to initiate a Phase 3 program to evaluate the safety and efficacy of DRM01 as a potential treatment for acne in adult and adolescent patients. The initiation of this program is targeted for the first half of 2017, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
“We are incredibly pleased that the data from this trial reaffirm the safety, efficacy and tolerability profile observed with DRM01 in our earlier Phase 2a proof-of-concept study,” said Tom Wiggans, chairman and chief executive officer of Dermira. “Each of the doses we evaluated demonstrated results that we believe could support their advancement into a Phase 3 program. We are encouraged by the potential of this molecule to target the underlying cause of acne following topical application. Our goal is to provide a transformative treatment option for the millions of people coping with acne and its impact on their quality of life.”
In the Phase 2b study, 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 on the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured at the end of a 12-week treatment period.
DRM01 demonstrated statistically significant improvements from baseline to week 12 relative to vehicle in all primary efficacy endpoints at the highest dose of DRM01 (7.5% twice daily), which also demonstrated the highest efficacy in all primary endpoints compared to the two lower doses. The number of inflammatory lesions in patients treated with this highest dose of DRM01 was reduced by an average of 15.0 compared to 10.7 in patients in the combined vehicle group (p=0.001), or an average percentage reduction of 55.6% compared to 40.0% (p<0.001). The number of non-inflammatory lesions in patients treated with this same dose of DRM01 was reduced by an average of 17.5 compared to 9.3 in patients in the combined vehicle group (p<0.001), or an average percentage reduction of 47.8% compared to 28.7% (p<0.001). At the end of the 12-week treatment period, 25.9% of patients treated with this highest dose of DRM01 achieved a successful improvement in the IGA score (minimum two-grade improvement) compared to 9.8% of patients in the combined vehicle group (p=0.004).
Overall, a dose response was observed for all three primary endpoints. At the 4.0% once daily dose, DRM01 demonstrated statistically significant improvements in all three primary endpoints compared to the combined vehicle group. At the 7.5% once daily dose, DRM01 demonstrated statistically significant improvements in the inflammatory and non-inflammatory lesion count endpoints compared to the combined vehicle group, and approached statistical significance in the IGA improvement endpoint (p=0.06). Based on the results, Dermira believes each of the three doses evaluated in the Phase 2b study could be a viable dose for a Phase 3 program. Further data analysis and an end-of-Phase 2 meeting with the FDA are expected to determine the dose and design for the Phase 3 program.
Consistent with the Phase 2a study, DRM01 was well-tolerated. Adverse events were primarily mild or moderate in severity. The most frequently reported adverse events across all three DRM01 treatment groups were common cold (nasopharyngitis; 5.4%), upper respiratory tract infection (2.5%) and application site itching (pruritus; 2.5%). No treatment-related serious adverse events were reported.
“DRM01 is an investigational, topical agent that represents a novel approach to acne treatment by targeting sebum production, a key contributing factor in the development of acne,” said Linda Stein Gold, M.D., director of Dermatology Clinical Research and division head of Dermatology at Henry Ford Hospital (Detroit, Michigan) and one of the investigators for the DRM01 Phase 2b trial. “Based on these results, DRM01 could represent a potentially meaningful new treatment for the dermatology community that offers patients a safe, well-tolerated and effective alternative to current options.”
The data will be submitted for presentation at an upcoming medical conference and for consideration in a peer-reviewed journal.
About DRM01 Phase 2b Trial
The DRM01 Phase 2b trial was a randomized, multi-center, double-blind, parallel-group, vehicle-controlled study designed to assess the safety and efficacy of DRM01 compared to vehicle in adult patients 18 and older with moderate-to-severe facial acne vulgaris. A total of 420 patients were enrolled in the study at 34 sites in the United States and Canada. 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 randomized into five separate arms and instructed to apply DRM01 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. Consistent with the previous Phase 2a trial and in accordance with the published FDA draft guidance for the development of acne drugs, 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 IGA score. Each endpoint was measured at the end of the 12-week treatment period.
According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting approximately 50 million Americans. Acne is caused by the accumulation of dead skin cells, oil and bacteria in pores. It is characterized by clogging of the pores and associated local skin lesions. Acne lesions are believed to result from an interaction of multiple pathogenic, or contributing, factors, including excessive sebum production. Acne is not just about blemishes on the skin; it can also affect a person’s quality of life, resulting in social, psychological and emotional impairments.
DRM01 is a novel, small molecule designed to inhibit sebum production following topical application 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.
Conference Call and Webcast
Dermira management will host a webcast and conference call regarding this announcement at 5:30 a.m. PT / 8:30 a.m. ET today. The live call may be accessed by dialing 877-359-9508 for domestic callers and 224-357-2393 for international callers and using the conference code: 6936436. A live webcast and archive of the call will be available from the investor relations sections of the company website at www.dermira.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 6936436.
Dermira is a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases. Dermira’s portfolio includes three late-stage product candidates that target significant unmet needs and market opportunities: CIMZIA® (certolizumab pegol), in Phase 3 development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; DRM04, in Phase 3 development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); and DRM01, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
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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 statements with respect to the timing and initiation of a Phase 3 program for DRM01; the prospective end-of-Phase 2 meeting with the FDA; the dose and design for the Phase 3 program; the potential of DRM01 to target the underlying cause of acne following topical application; and the potential and delivery of DRM01 as a transformative, safe and effective alternative treatment for patients with acne. 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 our anticipated end-of-Phase 2 meeting with the FDA for DRM01; the design, implementation and outcome of our planned DRM01 Phase 3 program; our dependence on third-party clinical research organizations, manufacturers and suppliers; our ability to obtain regulatory approval for our product candidate; and our ability to continue to stay in compliance with applicable laws and regulations. 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, you should refer to the section entitled “Risk Factors” set forth in our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings we make with the SEC from time to time. 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.
Senior Director, Head of Corporate Communications
Chief Operating Officer and Chief Financial Officer
Robert H. Uhl