WASHINGTON, April 1 (UPI) — A new drug to treat moderate to severe eczema nearly or completely cleared skin lesions in patients during two recent clinical trials, according to the drug’s developers.
Regeneron Pharmaceuticals and Sanofi announced today that more than one-third of patients in the trials saw the condition clear, and more than two-thirds showed significant improvement in their condition at the end of the trials.
More than 30 million people may have atopic dermatitis, or eczema, a chronic itchy, red rash that appears in different areas and at different levels of discomfort, according to the National Eczema Association.
Dupilumab targets the IL-4 and IL-13 signaling pathways in cells, which play a large role in the inflammation causing eczema.
The drug was granted a breakthrough therapy designation by the U.S. Food and Drug Administration in 2014, though dupilumab has not been fully evaluated for safety or efficacy by any regulatory authority, the two pharmaceutical companies said, making the new trial results a significant indicator of the drug’s potential.
“There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need,” Dr. Elias Zerhouni, president for global research and development at Sanofi, said in a press release. “These results may bring new hope to atopic dermatitis patients, many of whom have suffered for years.”
For the LIBERTY AD SOLO 1 and SOLO 2 trials, researchers recruited 1,379 adults with moderate to severe eczema whose condition was not controlled by topical medications or could not use one for other medical reasons. For the two trials, which were identical, patients received either 300 milligrams of dupilumab once a week, 300 milligrams of dupilumab, an initial 600 milligram dose of dupilumab and then placebo for the rest of the trial, or a placebo for the duration of the trial.
In SOLO 1, 37 percent of patients getting weekly injections and 38 percent of patients getting injections every two weeks showed clearing or near-clearing of skin lesions. Just 10 percent of patients receiving placebos saw this effect. Overall, 72 percent of the group getting a weekly injection saw some improvement and 72 percent getting an injection every two weeks saw some improvement, while 38 percent of the placebo group saw improvement.
Similarly, in SOLO 2, 36 percent of patients getting weekly injections and 36 percent of patients getting injections every two weeks showed clearing or near-clearing of skin lesions, while only 8.5 percent of patients who received placebos saw this effect. Sixty-nine percent of patients in this trial receiving weekly injections saw some improvement, while 67 percent receiving a shot every two weeks had improvement and just 31 percent of the placebo group improved.
The company plans to present detailed results of the trials at some point in the future, and will submit an application to the FDA later this year, Zerhouni said.
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