The primary endpoints of the Phase 2a trial, the changes from baseline in inflammatory and non-inflammatory lesion counts and an improvement in the Investigator's Global Assessment score, were met with statistical significance. There were no reported serious treatment-related adverse events, and DRM01 was generally well tolerated.
"We are delighted to have the positive Phase 2a results for our DRM01 acne program presented at the
The details of the presentation are as follows:
|Title: DRM01 (a Novel Topical Sebum Inhibitor) Demonstrates Safety and Evidence of Efficacy in a Phase 2a, Randomized, Vehicle-Controlled Study in Subjects with Acne Vulgaris, Offering a Novel Approach to Therapy|
|First Author: Robert Bissonnette, M.D., Innovaderm Research, Inc.|
|Poster Viewing Times: Tuesday, June 9 through Friday, June 12, 2015, 9:00 a.m. to 5:00 p.m. PDT|
|Session: Poster Session|
|Room: International Poster Gallery, Exhibit Hall|
|Abstract Number: 3087176|
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).
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.
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, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, 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 the results of the Phase 2b trial 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 risks set forth in Part II, Item 1A, "Risk Factors" in the Company's Quarterly Report on Form 10-Q and other filings the Company makes with the
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