Clinical trial results for tildrakizumab, a biologic drug currently in development, suggest that zeroing in on one particular protein in the immune system could greatly improve psoriasis.
The target for tildrakizumab, an injectable drug, is a cytokine called interleukin-23 (IL-23). Cytokines are proteins responsible for the inflammation seen in psoriasis. Biologic drugs for psoriatic disease work by targeting various cytokines, such as IL-17 and tumor necrosis factor-alpha. Stelara (ustekinumab) is a biologic that targets both IL-12 and IL-23.
Results from a Phase I trial for tildrakizumab appeared in Nature earlier this week.
In the first part of the study, patients receiving the highest doses of tildrakizumab every two months saw a 75 percent improvement in their psoriasis, also known as PASI 75, after six months on the drug. In the second part of the study, when patients received the drug roughly once a month, 23 of the 29 patients on these doses experienced at least PASI 75, with seventeen experiencing PASI 90, after about three-and-a-half months, researchers reported.
Patients taking the placebo averaged about a 20 percent improvement in their psoriasis, as reported in the data. Two patients on the placebo reached PASI 75, according to Dr. Sauzanne Khalilieh, a co-author of the study. Tildrakizumab is manufactured by Merck. The most common side effects experienced by patients on tildrakizumab were headache, the common cold, upper respiratory tract infection and cough, as reported in the study.
In addition to measuring skin clearance, researchers also tested skin samples from people in the study to better understand the effects of tildrakizumab on skin cells. They found that after taking tildrakizumab, psoriasis patients had lower levels of certain immune cells in the skin that can lead to inflammation. The results from the Phase I trial indicate that targeting IL-23 alone could be an effective strategy for treating psoriasis, the researchers conclude.
A Phase II trial testing tildrakizumab for psoriasis has completed, and two Phase III trials are currently underway, according to ClinicalTrials.gov.
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