Trial drug clears skin better than Stelara

| Melissa Leavitt

In a head-to-head clinical trial, a new biologic called BI 655066 beat out Stelara (ustekinumab) in delivering clearer skin to more patients.

BI 655066 is a drug being developed by Boehringer Ingelheim to treat psoriasis.

It is not yet available by prescription. Initial results from the phase II trial, testing how many patients experienced at least a 90 percent improvement in their skin after three months, were presented at the American Academy of Dermatology meeting in March 2015 in San Francisco. The trial was ongoing at that time and will probably last about a year, according to researchers.

Patients enrolled in the trial were randomly assigned to receive injections of various doses of either BI 655066 or Stelara. According to the results, after three months, more patients on the two highest doses of BI 655066 — 90 milligrams (mg) or 180 mg — achieved at least a 90 percent improvement in their skin.

About 77 percent of patients on these doses of BI 655066 experienced this level of improvement, compared with only 40 percent of patients on Stelara, researchers reported.

Similar numbers of patients on both drugs experienced side effects during the study, according to the data. The most common side effects were the common cold and headaches, researchers reported.

Four patients on BI 655066, and one patient on Stelara, experienced serious health events, but none were related to the treatments, according to the researchers.

Earlier in March, data from a Phase I trial of BI 655066 were published in the Journal of Allergy and Clinical Immunology. In that trial, more than half of patients on the drug experienced at least a 90 percent improvement in psoriasis after three months, researchers reported.

BI 655066 targets a protein called interleukin-23 (IL-23). IL-23 is a cytokine, or protein produced by the body, that leads to the inflammation seen in psoriasis. Stelara targets both IL-23 and another cytokine known as IL-12.

Clinical trials results from another biologic in development targeting IL-23, known as tildrakizumab, were also published earlier in March.


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