Dermira Inc. said a mid-stage study of lebrikizumab met its main goal of treating skin among patients with atopic dermatitis, the most common and severe form of eczema.
Atopic dermatitis is a chronic inflammatory condition characterized by persistent itching and red, dry, cracked skin that covers much of the body.
The phase 2b study compared the efficacy of three doses of lebrikizumab with placebo for 16 weeks among 280 patients aged 18 years and older with moderate-to-severe atopic dermatitis.
The three doses of lebrikizumab involved in the study were: 125 milligrams every four weeks, 250 milligrams every four weeks and 250 milligrams every two weeks.
The study demonstrated that all three doses of lebrikizumab led to statistically significant improvement in skin compared to placebo. Patients given the 250-milligram doses also achieved statistically significant improvement in the secondary goal of skin clearance. However, patients given 125-milligram lebrikizumab did not meet statistical significance in that goal.
The study showed low rates of side effects among patients given lebrikizumab. The Menlo Park, Calif.-based company said, overall the side effects in lebrikizumab-treated patients were mild to moderate and rarely led to treatment discontinuation.
Dermira said it plans to move lebrikizumab in phase 3 clinical development program by the end of 2019 following discussions with the U.S. Food and Drug Administration.
The company previously announced a deal with Almirall SA giving the Spanish drugmaker an option to license lebrikizumab in Europe as a treatment for atopic dermatitis and certain other diseases.
Almirall, which already agreed to pay $30 million up front, could exercise the option once Dermira posted the results of this study leading to another payment of $50 million.
Further, Almirall is expected to pay another $30 million to launch the phase 3 studies for lebrikizumab and up to $85 million on the achievement of certain regulatory milestones.
Dermira's stock price nearly doubled following the news to $13.61 per share as of 10:57 a.m. ET on March 18.