Dermira Stock Is Tanking: Here Is Why

Dermira stock is down heavily today following posted results of to phase 3 pivotal clinical trials for its leading drug candidates for moderate-to-severe acne vulgaris. None of the co-primary endpoint results were statistically significant.

Dermira stock (DERM) is tanking today. Prior to today, Dermira stock had been performing rather well as it awaited data releases. Like many biotech stocks a binary endpoint was coming for Dermira stock. Today, Dermira stock is cratering because it just reported Phase 3 trial data that was statistically insignificant for one of its leading drug candidates. Let us discuss.

Two phase 3 trials were ongoing, it's two Phase 3 pivotal trials (CLAREOS-1 and CLAREOS-2) were in patients ages nine years and older with moderate-to-severe acne vulgaris. The results were less than encouraging and Dermira stock is getting nailed for it. So what were they measuring?

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.

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% and 16.3%, respectively, compared to 20.8% and 11.8%, respectively, of patients in the corresponding vehicle groups. None of these co-primary endpoint results were statistically significant.

So where does Dermira stock go from here? We while the company is continuing to analyze the outcome of the olumacostat glasaretil Phase 3 program, we expect that Dermira will fully discontinue the development program, and move on to other ventures.

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