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Dermira announces positive top-line Phase 2b results for DRM01 in patients with facial acne vulgaris
05-10-2016
by Jeffrey Bouley  |  Email the author
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MENLO PARK, Calif.—Dermira Inc., a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, announced May 10 top-line 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, according to the company, demonstrated statistically significant improvements in all primary endpoints compared to 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—in fact, results at all dosage levels gave Dermira hope for the compound’s future.
 
“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 CEO 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.”
 
And, in fact, Dermira does plan to initiate a Phase 3 program, based on the success of the Phase 2b study, 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).
 
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 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 percent 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, or an average percentage reduction of 55.6 percent compared to 40 percent. 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, or an average percentage reduction of 47.8 percent compared to 28.7 percent. At the end of the 12-week treatment period, 25.9 percent 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 percent of patients in the combined vehicle group.
 
Overall, a dose response was observed for all three primary endpoints. At the 4-percent once daily dose, DRM01 demonstrated statistically significant improvements in all three primary endpoints compared to the combined vehicle group. At the 7.5-percent 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. 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, upper respiratory tract infection and application site itching. 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 Dr. Linda Stein Gold, director of Dermatology Clinical Research and division head of Dermatology at Henry Ford Hospital in Detroit 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.”
 
Dermira also announced first quarter financial results the same day it released the news above, with Wiggans noting: “Dermira has already made significant progress this year, starting with the completion of patient enrollment for our DRM01 Phase 2b acne trial and DRM04 Phase 3 hyperhidrosis pivotal trials, as well as the recent positive results for the DRM01 trial. Looking ahead, we expect to announce topline data for the two DRM04 Phase 3 pivotal trials by the end of this quarter and for our three Cimzia Phase 3 trials by the end of the first quarter of next year. We are encouraged by what the results from these programs could mean not only for Dermira, but for the millions of patients living with these skin diseases.”
 
Among the highlights shared in the financial results aside from the DRM01 results:
  • Completed patient enrollment in DRM04 Phase 3 pivotal trials in patients with hyperhidrosis—In February 2016, Dermira completed enrollment in its DRM04 ATMOS-1 and ATMOS-2 Phase 3 clinical trials, which collectively enrolled 697 patients with primary axillary hyperhidrosis.
  • Announced completion of patient enrollment in third and final Cimzia Phase 3 clinical trial—In January 2016, Dermira announced the completion of enrollment in its CIMPACT Phase 3 clinical trial of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. The company had previously completed enrollment for its other two Cimzia Phase 3 trials, CIMPASI-1 and CIMPASI-2. Collectively, the Phase 3 Cimzia program enrolled 1,020 patients. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
  • Dermira’s co-founder, Dr. Eugene A. Bauer, received a Presidential Citation from the American Academy of Dermatology—In March 2016, Dermira announced that Bauer, also the chief medical officer of Dermira, received a Presidential Citation from the American Academy of Dermatology (AAD). Dr. Bauer received the award at the Stars of the Academy Reception in Washington, D.C., held on March 3, 2016 during the annual meeting of the AAD.
 
Code: E05111602

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