The stock is up more than 100 percent after the company announced positive results from a Phase IIb study of lebrikizumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis.
Shares of Dermira, Inc. have skyrocketed in premarket trading. The stock is up more than 100 percent after the company announced positive results from a Phase IIb study of lebrikizumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis.
This morning, Menlo Park, Calif.-based Dermira, said in its dose-ranging study of lebrikizumab, all three doses of the treatment met the primary endpoint, demonstrating greater improvements in the Eczema Area and Severity Index (EASI) score compared to placebo. The company said patients on the 125-milligram dose saw a 62.3 percent improvement. Patients who received the higher dose of 250 mg every four weeks saw a 72.1 percent improvement. Those who took the 250 mg dose every two weeks actually saw a lower improvement of 41.1 percent, the company said.
Additionally, Dermira said patients treated with lebrikizumab at the 250 mg dose every two or four weeks achieved statistically significant improvements in other key efficacy measures compared to placebo after 16 weeks of treatment. That included a 33.7 and 44.4 percent clearing or near-clearing of skin lesions, as measured by an investigator’s global assessment, respectively.
The secondary endpoints for the 125 mg lebrikizumab dosing arm did not meet statistical significance.
The safety profile of the treatment remained consistent with prior studies, the company said.
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with high affinity. The drug is designed to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex, which inhibits downstream signaling, the company said. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection. Dermira licensed lebrikizumab from Roche in 2017.
Tom Wiggins, chairman and chief executive officer of Dermira, said the company plans to quickly move into a Phase III program for lebrikizumab after it discusses the plan with the U.S. Food and Drug Administration. Based on the clinical profile of lebrikizumab observed in the Phase II study, Wiggins said the company believes the treatment “has the potential to be a best-in-disease therapy for atopic dermatitis.” The company anticipates it can begin Phase III development by the end of 2019.
Emma Guttman-Yassky, the lead study investigator and director of the Center of Excellence in Eczema at Icahn School of Medicine at Mount Sinai, said the data from the Phase IIb trial is compelling and clinically demonstrated that IL-13 is a key mediator in atopic dermatitis. Guttman-Yassky said she has many current patients who have not had their atopic dermatitis needs adequately met by current therapies. She noted that the data from the Phase II trial indicates that “lebrikizumab may offer a targeted, effective and well-tolerated therapeutic approach.”
