On March 7, the New England Journal of Medicine published the results of a Phase I study of BI 655139 in the treatment of generalised pustular psoriasis (GPP).
Pustular psoriasis is a rare type of psoriasis, accounting for no more than 1%. It is usually divided into generalized pustular psoriasis and palmoplantar psoriasis. Generalized pustular psoriasis, with more limbs and wrinkles in the limbs, can also affect the whole body, the skin lesions are first based on acute inflammatory erythema, most dense needles to miliary size aseptic superficial Pus, with a small amount of scaly scales.
Generalized pustular psoriasis is rare, sometimes accompanied by fever and body wilting, and in some serious cases can lead to organ failure and serious infection, which in turn threatens life. In this case, patients need to be hospitalized for local and systemic medications, including immunosuppressive agents that control inflammation, anti-TNF drugs, and antibiotics that prevent infection. Targeted therapies that do not have rapid relief symptoms are available. BI 655139 is the first in class of anti-IL-36 monoclonal antibody developed by Boehringer Ingelheim.
In this phase I study, 7 patients received intravenous BI 655139, 3 patients achieved complete pustule clearance 48 hours after injection, and 5 patients achieved skin lesion improvement after 1 week, 4 weeks later The average lesion area of the 7 patients improved by nearly 80%, and this effect was maintained until the 20th week.
The study author is Bollinger Ingelheim’s CNS and head of drug development for immune diseases, Jan Poth, who pointed out: “We are one of the first companies to focus on the development of IL-36 targeted therapies in dermatology, and further research is needed. To explore the efficacy and duration of BI 655139, adverse reactions. Based on the results of the Phase I study, we will start the Phase II study of BI 655139 in more patients with generalized pustular psoriasis as soon as possible.”
The initial success of BI 655139 in the generalized pustular psoriasis trial also suggests the potential of this drug in other immune diseases, such as the more common inflammatory bowel disease. Currently, BI 655139 is also under investigation in palmoplantar pustulosis, ulcerative enteritis, Crohn’s disease, and atopic dermatitis.
There are not many companies developing the IL-36 project. The other is AnaptysBio in the United States. Its product ANB019 is in Phase II and is expected to be published in the generalized pustular psoriasis and palmoplantar pustulosis at the end of this year. Period results.