Dermira is pulling the plug on its experimental acne drug, olumacostat glasaretil, after it missed its primary endpoints in a pair of phase 3 trials.
The pivotal trials tested olumacostat glasaretil, previously called DRM01, in patients aged nine and older with moderate to severe acne vulgaris. The drug is designed to treat acne by targeting the overproduction of sebum, a cause of acne that existing topical meds do not address.
But it failed to beat out placebo at reducing the number of inflammatory and noninflammatory lesions. And the percentages of treated patients who achieved 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 closely resembled the numbers for the placebo group.
“We are surprised and extremely disappointed by the results of the Phase 3 program,” said Tom Wiggans, Dermira CEO, in a statement. “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.”
While the company is still looking over the phase 3 results, it expects to discontinue the program, Luis Peña, Dermira chief development officer, said.
Dermira will now concentrate on its other programs, which include glycopyrronium tosylate for axillary hyperhidrosis, or excessive sweating. In 2016, the drug passed one phase 3 trial and missed the mark on another, though analysts said this should be sufficient to yield an FDA nod.
The company also expects to read out topline phase 2 data for lebrikizumab, a treatment for atopic dermatitis, in the first half of 2019. Dermira picked up the exclusive worldwide rights to the monoclonal antibody from Roche last August, though the Big Pharma still holds rights to the drug in some indications.