March 28, 2022
An experimental eczema drug significantly improved dry skin and itch symptoms within four weeks among people with moderate-to-severe forms of the skin disease, the Eli Lilly Company said.
New data from two ongoing clinical trials found that more than 50% of participants experienced at least a 75% reduction in disease severity. The drug, a monoclonal antibody that is being fast-tracked by the U.S. Food and Drug Administration, eventually could provide another treatment option for people with eczema.
Eczema, formally known as atopic dermatitis, is a chronic inflammatory disease that causes intense itching, dry skin and inflammation on any part of the body. It often flares up in periods of intense symptoms that can affect a person's sleep, daily activities and relationships.
The experimental drug, lebrikizumab, is currently in Phase 3 trials. Eli Lilly plans to submit data for FDA approval by the end of the year.
The drug was granted FDA fast track status in December 2019. That status is given to drugs that treat serious conditions that affect survival and day-to-day functioning, and fill unmet medical needs. The designation expedites the regulatory review of the drug.
According to the FDA, filling an unmet medical need is defined as providing a therapy where none exists or providing one that is potentially superior to the treatments currently available. Fast tracking includes more frequent meetings with the FDA and eligibility for accelerated approval, if certain criteria are met.
Current eczema treatment options include corticosteriod creams, oral corticosteriods, creams that contain immunosuppressants and light therapy. An injectable monoclonal antibody called dupilumab is available for severe eczema that doesn't respond to other treatments.
Lebrikizumab blocks a protein that has a central role in skin inflammation, including skin barrier dysfunction, itch, infection and hard, thickened areas of skin.
"Patients with atopic dermatitis experience persistent itch, dry skin, severe pain and inflammation, which can be unpredictable and affect their work, social relationships, mental and emotional health," said Dr. Emma Guttman-Yassky, a dermatologist at the Ichan School of Medicine at Mount Sinai in New York. She is a senior author of the research analyses.
"I'm encouraged by today's data showing rapid improvements in skin, itch and quality-of-life measures."
Two 52-week clinical trials are evaluating lebrikizumab in adult and adolescent patients with moderate-to-severe eczema. Participants received a 500 mg dose at the start of the trial and again two weeks later. They then received a 250 mg dose or a placebo every two weeks until the 16-week mark.
In one study, 43% of participants who received the drug achieved clear or almost clear skin at 16 weeks compared to just 13% of participants who received a placebo. In a second study, those figures were 33% and 11%, respectively.
The trials are part of a Phase 3 program that includes five global studies, including one that combines lebrikizumab with topical steroids.
Within four weeks, all participants who received the drug experienced statistically significant improvements in skin clearance and itching, and improvements in quality of life. Most side effects were mild or moderate in severity and didn't lead to treatment discontinuation. The most common adverse events were pink eye, common cold and headache.
"These data reinforce the positive results in our broader Phase 3 development program, and we believe lebrikizumab represents a new generation of biologics for atopic dermatitis," said Dr. Lotus Mallbris, vice president of global immunology development and medical affairs at Lilly.