An experimental drug developed by Dermira to treat atopic dermatitis has hit the main goal of its mid-stage study, helping to build a case that the injectable treatment could measure up against a drug from Regeneron Pharmaceuticals and Sanofi.
Atopic dermatitis is the most common and severe form of eczema, an inflammatory condition that leads to rashes, redness, and chronic itching of the skin. It affects an estimated 16.5 million adults in the U.S. In clinical trial results released Monday, Dermira reported that each of three doses of its drug, lebrikizumab, demonstrated improvement in an assessment used to measure eczema severity.
Shares of Menlo Park, CA-based Dermira (NASDAQ: DERM) shot up more than 112 percent to $14.56 following the news.
Lebrikizumab is an antibody drug developed to bind to interleukin-13, a protein believed to play a role in the development of atopic dermatitis. The drug is administered as a monthly injection.
The Phase 2b study enrolled 280 adults with moderate-to-severe atopic dermatitis, randomized to receive one of three doses of the Dermira drug or a placebo for 16 weeks. The improvement in the eczema assessment score was 62.3 percent for the 125 mg dose and 69.2 percent for the 250 mg dose. The results were even better in a third group given the 250 mg dose every two weeks, with scores improving 72.1 percent. The change in the eczema assessment was 41.1 percent in the placebo group.
The most common side effects reported across all three doses were upper respiratory tract infections, nasal inflammation, headache, and injection site pain. Dermira said that the safety profile of the drug was consistent with earlier studies, in which side effects were “nonserious” and lasted between one and three days.
Dermira licensed rights to lebrikizumab from Roche in 2017. The company is aiming to compete against Regeneron (NASDAQ: REGN) and partner Sanofi (NYSE: SNY), which won FDA approval in 2017 for dupilumab (Dupixent) as a treatment for atopic dermatitis in adults. That injectable drug, given every two weeks, blocks two proteins: interleukin 4 and interleukin 13. It generated more than $921 million in global sales last year. Last week, the FDA expanded the drug’s approval to include adolescent patients.
A monthly dose of lebrikizumab could offer a dosing advantage compared to the Regeneron/Sanofi drug. In a research note, Evercore ISI analyst Umer Raffat wrote that the results for the 250 mg dose of the Dermira drug were comparable to dupilumab. He added that the twice monthly 250 mg dose of the Dermira drug also appears to be competitive against dupilumab.
Dermira says it plans to advance lebrikizumab into Phase 3 testing by the end of this year.