MENLO PARK, Calif., Oct. 21, 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, presented data from its DRM01 Phase 2b clinical trial at the 35th Anniversary Fall Clinical Dermatology Conference in Las Vegas.
Positive topline results from the DRM01 Phase 2b dose-ranging clinical trial were previously reported in May 2016. The trial evaluated the safety and efficacy of DRM01, a novel, small molecule designed to inhibit sebum production following topical application. The primary endpoints for the trial 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 assessed by comparison of baseline values with those measured at the end of a 12-week treatment period.
“Acne is one of the most common skin conditions affecting millions of people of all ages,” said Jim Del Rosso, D.O., an adjunct clinical professor of dermatology at Touro University College of Osteopathic Medicine.* “Although the marketplace is full of prescription and over-the-counter treatment options for patients, very few target one of the underlying causes of acne in both a safe and effective manner for patients.”
As previously reported, DRM01 demonstrated statistically significant improvements from baseline to week 12 relative to vehicle in all primary efficacy endpoints at the highest dose of DRM01 tested and in most primary endpoints at the two lower doses tested. DRM01 was well-tolerated across all three doses, with adverse events primarily mild or moderate in severity.
DRM01 Dose: 7.5% twice daily
At the 7.5% twice daily dose, DRM01 demonstrated statistically significant improvements from baseline to week 12 relative to vehicle in all primary efficacy endpoints. This highest dose of DRM01 also demonstrated the highest efficacy in all primary endpoints compared to the two lower doses.
- Following 12 weeks of treatment, 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 same 12-week treatment period, 25.9% of patients 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).
DRM01 Dose: 7.5% once daily
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 but did not reach statistical significance in the IGA improvement endpoint.
- Following 12 weeks of treatment, the number of inflammatory lesions in patients treated with this dose of DRM01 was reduced by an average of 14.5 compared to 10.7 in patients in the combined vehicle group (p=0.004), or an average percentage reduction of 53.3% compared to 40.0% (p=0.004). The number of non-inflammatory lesions in patients treated with DRM01 at the 7.5% dose once daily was reduced by an average of 13.4 compared to 9.3 in patients in the combined vehicle group (p=0.050), or an average percentage reduction of 36.6% compared to 28.7% (p=0.152).
- At the end of the same 12-week treatment period, 19.2% of patients achieved a successful improvement in the IGA score (minimum two-grade improvement) compared to 9.8% of patients in the combined vehicle group (p=0.063).
DRM01 Dose: 4.0% once daily
At the 4.0% once daily dose, DRM01 demonstrated statistically significant improvements in all three primary endpoints compared to the combined vehicle group.
- Following 12 weeks of treatment, the number of inflammatory lesions in patients treated with this dose of DRM01 was reduced by an average of 14.6 compared to 10.7 in patients in the combined vehicle group (p=0.003), or an average percentage reduction of 54.8% compared to 40.0% (p=0.002). The number of non-inflammatory lesions in patients treated with DRM01 at the 4.0% dose once daily was reduced by an average of 15.3 compared to 9.3 in patients in the combined vehicle group (p=0.004), or an average percentage reduction of 42.1% compared to 28.7% (p=0.014).
- At the end of the same 12-week treatment period, 21.6% of patients achieved a successful improvement in the IGA score (minimum two-grade improvement) compared to 9.8% of patients in the combined vehicle group (p=0.024).
“We are excited to share additional results from the Phase 2b clinical program with the dermatology community, which demonstrate that DRM01 could potentially be a safe and effective treatment option for patients suffering from acne,” said Eugene A. Bauer, M.D., chief medical officer of Dermira. “We look forward to initiating our Phase 3 clinical program for DRM01.”
DRM01 was well-tolerated in the Phase 2b trial. 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.
Based on the results of the Phase 2b trial and an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), 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, consistent with previous guidance.
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.
About Acne
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.
About DRM01
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.
About Dermira
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 Phase 2b development for the treatment of facial acne vulgaris. Dermira is headquartered in Menlo Park, California. For more information, please visit www.dermira.com.
In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.
Forward-Looking Statements
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 potential use of DRM01 as a safe and effective treatment option for patients with acne and the timing, initiation, dose and design of a Phase 3 program for DRM01. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause 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 design, implementation and outcome of Dermira’s planned DRM01 Phase 3 program; the outcome of Dermira’s future discussions with regulatory authorities relating to the DRM01 clinical program; Dermira’s ability to obtain regulatory approval for DRM01; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. For a discussion of important factors that may cause Dermira’s actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements, you should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes 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.
*Disclaimer: Dr. Del Rosso serves as a paid advisor to Dermira. He does not have a financial interest in the company.
Contacts: Media: Erica Jefferson Senior Director, Head of Corporate Communications 650-421-7216 erica.jefferson@dermira.com Investors: Andrew Guggenhime Chief Operating Officer and Chief Financial Officer 650-421-7200 investors@dermira.com Robert H. Uhl Westwicke Partners Managing Director 858-356-5932 robert.uhl@westwicke.com
