Dermira, Inc., a biopharmaceutical company that focuses on delivering new therapies to patients living with chronic skin conditions, announced that the investigational treatment olumacostat glasaretil (formerly DRM01) did not meet the co-primary endpoints in its two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) in patients ages nine years and older with moderate-to-severe acne vulgaris.
“We are surprised and extremely disappointed by the results of the Phase 3 program,” said Tom Wiggans, chairman and chief executive officer of Dermira. “This is disappointing not only for the company, but also for patients who are living with this condition and dermatologists who have been looking for novel therapies to treat them.”
“We are continuing to analyze the outcome of the olumacostat glasaretil Phase 3 program. However, based on the information we have to date, we expect to discontinue the development program,” said Luis Peña, chief development officer of Dermira. “We want to thank our employees, investigators, and partners for their commitments to the acne development program and, most importantly, the patients who participated in these trials.”
The co-primary endpoints of CLAREOS-1 and CLAREOS-2 were the absolute changes from baseline in inflammatory and non-inflammatory lesion counts and the proportion of patients achieving at least a two-grade improvement from baseline to a final grade of zero or one on the five-point Investigator’s Global Assessment (IGA) scale. Each endpoint was measured on the face at the end of the 12-week treatment period. Safety and tolerability were also evaluated.
Phase 3 Results
- The reductions in the numbers of inflammatory lesions from baseline to week 12 in patients treated with olumacostat glasaretil in CLAREOS-1 and CLAREOS-2 were 14.3 and 16.6, respectively, compared to 13.7 and 15.3, respectively, in patients in the corresponding vehicle groups.
- The reductions in the numbers of non-inflammatory lesions from baseline to week 12 in patients treated with olumacostat glasaretil in CLAREOS-1 and CLAREOS-2 were 14.8 and 17.8, respectively, compared to 11.2 and 17.4, respectively, in patients in the corresponding vehicle groups.
- In CLAREOS-1 and CLAREOS-2, the percentages of patients treated with olumacostat glasaretil who achieved a two-grade improvement from baseline to a final grade of zero or one on the IGA scale at week 12 were 19.1 percent and 16.3 percent, respectively, compared to 20.8 percent and 11.8 percent, respectively, of patients in the corresponding vehicle groups.
- None of these co-primary endpoint results were statistically significant.
Consistent with the Phase 2a and 2b studies, olumacostat glasaretil was well-tolerated. Adverse events were primarily mild or moderate in severity. No treatment-related serious adverse events were reported, and no new or unexpected events were observed.
“We remain dedicated to bringing new treatments to people living with chronic, underserved skin conditions. As we look ahead, we are focused on building a commercial organization to support the anticipated launch of glycopyrronium tosylate for axillary hyperhidrosis later this year, subject to FDA approval, as well as our Phase 2b trial evaluating lebrikizumab as a potential treatment for moderate-to-severe atopic dermatitis, for which we expect to announce topline data in the first half of 2019,” added Wiggans.
The Phase 3 clinical program included two randomized, multi-center, double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2, designed to assess the efficacy and safety of olumacostat glasaretil compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food & Drug Administration (FDA). The program enrolled a total of 1,503 patients (CLAREOS-1, n=759 and CLAREOS-2, n=744) ages nine years and older with moderate-to-severe acne vulgaris at 94 sites in the United States, Canada, and Australia. In each trial, patients were randomized in a 2:1 fashion to receive either olumacostat glasaretil at a concentration of five percent or vehicle twice daily for 12 weeks.
The Phase 3 program also included an open-label study, CLARITUDE, assessing the long-term safety of olumacostat glasaretil, in which patients from either of the two Phase 3 studies were permitted to continue to receive treatment for up to an additional 36 weeks.
(Source: Globe Newswire)
Filed Under: Drug Discovery
