On March 3, 2016, Dermira presented primary results from the Phase IIb trial assessing the safety and efficacy of olumacostat glasaretil (OG) gel for the treatment of adult patients with facial acne vulgaris. OG is an acetyl coenzyme-A carboxylase (ACC) inhibitor, blocking key components of sebum production, including diglycerides, triglycerides, free fatty acids, wax esters, and essential nutrients for acnes. There are currently no topical therapies approved to address excessive sebum production in acne. If approved, OG would mark the first topical therapy for acne to specifically target excessive sebum production, addressing a key unmet need in the acne marketplace.
In the Phase IIb double-blind, dose-ranging, vehicle controlled trial, 420 patients were randomized 2:2:2:1:1 to receive OG 4% once daily, OG 7.5% once daily, OG 7.5% twice-daily, vehicle control once-daily, or vehicle control twice-daily all for 12 weeks. A significantly greater reduction in inflammatory acne lesion (IAL) and non-inflammatory acne lesion (NIAL) counts—both primary efficacy endpoints—from baseline were reported in all OG groups compared with vehicle groups at week 12, with the most significant improvements observed in the patients treated with OG 7.5% twice-daily compared with the combined vehicle (IAL: -15.0 compared with -10.7, p=0.001; NIAL: -17.5 compared with -9.3, p<0.001). In addition, clinically meaningful changes were noted in acne severity, with Investigator Global Assessment (IAG) response rates greater in all OG treatment groups compared with combined vehicle groups.
In January 2017, Dermira announced the start of the Phase III program assessing the safety and efficacy of OG in 1,400 patients ages nine and older with moderate-to-severe acne vulgaris. The clinical program includes two randomized, multi-center, double-blind, parallel-group, vehicle-controlled trials, CLAREOS-1 and CLAREOS-2, in which patients are randomized 2:1 to apply either OG or vehicle twice daily to the face for 12 weeks. Dermira anticipates topline results to be available in the first half of 2018, marking substantial progress towards the approval of the first topical therapy for acne to specifically target excessive sebum production.