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On October 25, Boehringer Ingelheim announced that it had submitted a marketing application for the first in class monoclonal antibody Spesolimab to NMPA for the treatment of the onset of generalized pustular psoriasis (GPP)
.
Generalized pustular psoriasis is a relatively rare subtype of psoriasis
.
It is characterized by repeated episodes of generalized pustules, often accompanied by high fever, which can be life-threatening in severe cases, and treatment is difficult.
In some patients with this disease, a loss-of-function mutation of IL36RN has been found.
IL36RN is used to encode an interleukin-36 receptor (IL-36R) antagonist
.
This finding suggests that the IL-36R signaling pathway may play a role in the pathogenesis of psoriasis
In March 2019, a literature published in the New England Journal of Medicine reported the results of a phase I proof-of-concept clinical study of BI655130 (Spesolimab) in the treatment of patients with generalized pustular psoriasis
.
The study included 7 patients with systemic GPP who received single-dose, open-label, BI 655130 (10mg/kg) treatment, and the mean initial GPPGA (generalized pustular psoriasis physician overall assessment) score of all patients It is 3 points (moderate disease, the higher the score, the more serious the condition), and the pustule sub-score is 2 to 4 points
The results of the study showed that the GPPGA score of 5 patients became 0 or 1 (cleared or almost completely cleared) after 1 week of treatment.
By the 4th week, the GPPGA score of all patients (with or without IL36RN mutation) became 0 or 1
.
Spesolimab belongs to the IL-36R monoclonal antibody.
On June 25 this year, it was awarded the breakthrough therapy qualification by CDE for its superior performance in the treatment of generalized pustular psoriasis phase I and phase II clinical trials
.
Boehringer Ingelheim’s submission of a listing application in China is based on Spesolimab’s global pivotal II clinical study
There are only a handful of companies developing IL-36R projects in the world, and currently only Huabo Biology is in phase I among domestic companies
.
On October 25, Boehringer Ingelheim announced that it had submitted a marketing application for the first in class monoclonal antibody Spesolimab to NMPA for the treatment of the onset of generalized pustular psoriasis (GPP)
.
Generalized pustular psoriasis is a relatively rare subtype of psoriasis
.
It is characterized by repeated episodes of generalized pustules, often accompanied by high fever, which can be life-threatening in severe cases, and treatment is difficult.
In some patients with this disease, a loss-of-function mutation of IL36RN has been found.
IL36RN is used to encode an interleukin-36 receptor (IL-36R) antagonist
.
This finding suggests that the IL-36R signaling pathway may play a role in the pathogenesis of psoriasis
In March 2019, a literature published in the New England Journal of Medicine reported the results of a phase I proof-of-concept clinical study of BI655130 (Spesolimab) in the treatment of patients with generalized pustular psoriasis
.
The study included 7 patients with systemic GPP who received single-dose, open-label, BI 655130 (10mg/kg) treatment, and the mean initial GPPGA (generalized pustular psoriasis physician overall assessment) score of all patients It is 3 points (moderate disease, the higher the score, the more serious the condition), and the pustule sub-score is 2 to 4 points
The results of the study showed that the GPPGA score of 5 patients became 0 or 1 (cleared or almost completely cleared) after 1 week of treatment.
By the 4th week, the GPPGA score of all patients (with or without IL36RN mutation) became 0 or 1
.
Spesolimab belongs to the IL-36R monoclonal antibody.
On June 25 this year, it was awarded the breakthrough therapy qualification by CDE for its superior performance in the treatment of generalized pustular psoriasis phase I and phase II clinical trials
.
Boehringer Ingelheim’s submission of a listing application in China is based on Spesolimab’s global pivotal II clinical study
There are only a handful of companies developing IL-36R projects in the world, and currently only Huabo Biology is in phase I among domestic companies
.
