On March 7, the New England Journal of Medicine published the results of a phase I study of BI 655139 in generalized pustular psoriasis (GPP).
Pustular psoriasis is a less common form of psoriasis, accounting for no more than 1% of psoriasis, and is usually divided clinically into generalized pustular psoriasis and palmoplantar psoriasis.Generalized pustular psoriasis, with more flexures and folds of the limbs, may also affect the whole body, the initial onset of skin lesions is on the basis of acute inflammatory erythema, the emergence of most dense needles to miliary size aseptic superficial pus cells, with a small amount of thin scales.
Generalized pustular psoriasis is rare, sometimes associated with fever and malaise, and some severe cases can lead to organ failure and serious infections that can be life-threatening.In this case, the patient needs to be hospitalized for treatment with topical and systemic medications, including immunosuppressants to control inflammation.Anti-TNF drugs and antibiotics to prevent infection.No targeted therapy for rapid symptom relief is available.BI 655139 is a first in class anti-IL-36 monoclonal antibody developed by Boehringer Ingelheim.
In this phase I study, after a single intravenous injection of BI 655139 in 7 patients, 3 patients achieved complete pustular clearance at 48 hours after injection, 5 patients achieved improvement in skin lesions after 1 week, and after 4 weeks, 7 patients achieved nearly 80% improvement in mean lesion area, and this effect was maintained through week 20.
"We are one of the first companies to focus on developing IL-36-targeted therapies in dermatology," said Jan Poth, director of drug development for CNS and immune diseases at Boehringer Ingelheim. "Further studies are needed to explore the efficacy and duration of BI 655139."Adverse reactions.Based on the results of the phase I study, we will initiate 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 disorders, such as the more common inflammatory bowel disease.Currently, BI 655139 in palmoplantar pustulosis.Ulcerative enteritis.Crohn's disease.Studies in atopic dermatitis are also ongoing.
There are not many companies developing the IL-36 program. The other is AnaptysBio in the United States, whose product ANB019 is in phase II and is expected to announce phase II results in generalized pustular psoriasis and palmoplantar pustulosis by the end of this year.