Dermira (DERM) Presents Data from DRM01 Phase 2b Trial

October 21, 2016 7:38 AM EDT
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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.



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