Skin-drug company Dermira today announced that two pivotal Phase 3 trials testing its experimental acne drug, olumacostat glasaretil, failed to meet their main goals. The company said that based on those results, it expects to stop development of the drug, which was designed to treat people with moderate to severe acne. Dermira’s (NASDAQ [[ticker:DERM]]) stock price plummeted more than 60 percent Monday morning, compared to Friday’s closing price.
“We are surprised and extremely disappointed by the results of the Phase 3 program,” said Tom Wiggans, chairman and chief executive officer of Menlo Park, CA-based Dermira, in a statement.
With its drug, the company was aiming to reduce the number of facial skin lesions in the two randomized, double-blind, controlled trials, CLAREOS-1 and CLAREOS-2, which treated a total of 1,500 adolescents and adults for 12 weeks. The other endpoint was the proportion of patients achieving a specific reduction in a five-point assessment score given by investigators. According to the company, none of the results in people taking the drug were statistically significant, when compared to those in people given an inactive control gel.
The topical drug was supposed to reduce the skin’s production of sebum, an oily substance that contributes to acne. In a note this morning, Leerink analysts said the results “may put into question the robustness of the sebum reduction mechanism alone, in the treatment of moderate-to-severe acne.”
Dermira has two other clinical-stage products in its pipeline. One is a treatment for excessive underarm sweating, which is now under review by the FDA. Its other experimental drug, lebrikizumab, for eczema, was licensed from Roche last year and is in Phase 2 studies.
