Taking just one dose of a new drug for psoriasis could give patients completely clear skin that lasts for more than a year, according to the results of a Phase I clinical trial for a drug known as BI 655066.
The injectable drug, which is being developed by Boehringer Ingelheim, targets a protein called interleukin-23 (IL-23). IL-23 is a cytokine, or pro-inflammatory protein, that leads to the inflammation seen in psoriasis.
Results from the trial were published last week in the Journal of Allergy and Clinical Immunology.
The trial involved 39 patients who took BI 655066, and eight patients who took a placebo.
The BI 655066 patients were given a single dose ranging from 0.01 milligrams (mg) to 5 mg. Most received the drug intravenously, but some patients taking the 0.25 mg or 1 mg doses received the drug subcutaneously, which means it was injected under the skin.
Some patients saw improvement in their psoriasis in as little as two weeks, according to the study.
Promising results at three and six months
After three months, 87 percent of patients who took any dose of the drug had at least 75 percent improvement in their psoriasis. Improvement was measured using the Psoriasis Area and Severity Index (PASI). More than half experienced 90 percent improvement, known as PASI 90, and 16 percent of patients developed completely clear skin, or PASI 100, according to the results.
After six months, 71 percent of patients who took any dose of the drug, along with one patient on placebo, achieved PASI 75. In addition, 48 percent of patients on the drug achieved PASI 90, while 29 percent achieved PASI 100 after six months, researchers reported.
When researchers narrowed down the results to include just patients taking the drug subcutaneously, results were even stronger. All of these patients experienced at least PASI 75 after six months, while 85 percent experienced PASI 90 and more than half experienced completely clear skin, researchers reported.
After six months, some patients in the subcutaneous group stayed in the study without taking any other psoriasis treatment. Six of the eight patients who stayed remained completely clear for up to more than a year, according to the data.
About two-thirds of patients taking BI 655066, and almost all of the patients on placebo, experienced a side effect, researchers reported. The most common side effects were upper respiratory tract infection, the common cold and headache. Although four patients on BI 655066 did experience serious side effects, none of them were related to the drug, according to the researchers.
Results from the BI 655066 suggest that patients may one day have new options for achieving lasting results, according to Dr. James Krueger, the lead author of the study and a dermatologist at The Rockefeller University.
“We are now approaching the point where long-term remission of disease might be possible,” Krueger said. “We might even be moving in the direction of a cure.”
Phase II clinical trials for BI 655066 are ongoing, according to ClinicalTrials.gov.
Results for another drug targeting IL-23, known as tildrakizumab, were published earlier this month.
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