Novel antibody shows potential to treat a rare form of psoriasis
- Published in The New England Journal of Medicine, new data show single dose BI 655130 rapidly improved symptoms of a rare and potentially life-threatening form of pustular psoriasis1
- BI 655130 is an investigational, potential first-in-class treatment targeting interleukin-36 receptor (IL-36R)
- BI 655130 is being studied in generalised pustular psoriasis (GPP) as the first of several indications, including inflammatory bowel diseases
Bracknell, UK, 7 March 2019 – The New England Journal of Medicine (NEJM) today published new data1 from a clinical trial showing BI 655130, a first-in-class investigational treatment, improved symptoms of generalised pustular psoriasis (GPP), which is a rare form of psoriasis. BI 655130 is an investigational monoclonal antibody that blocks the action of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system that plays a role in many inflammatory diseases.
The newly published clinical data from an open label proof of concept phase I study, evaluated a single intravenous dose of BI 655130 in patients with an acute, moderate or severe disease flare up of GPP.1 The severity of GPP was assessed using the Generalised Pustular Psoriasis Physician Global Assessment (GPPGA), a physician-based assessment of the severity of pustules, erythema (redness) and lesions, and the Generalised Pustular Psoriasis Area and Severity Index (GPPASI).
- Within 48 hours, pustules were cleared in three patients, and in six of the seven study participants by week two.1
- As assessed by the GPPGA, at the end of week one, clear or almost clear skin was achieved in five of seven patients, and in all study participants by week four.1
- The GPPASI showed an average percent improvement from baseline of 59.0% at week one, rising to 73.2% at week two and further to 79.8% at week four, which was maintained until the end of the study at week 20.1
- No serious adverse events were reported; all adverse events were graded as mild or moderate.1
BI 655130 is an investigational compound. Its safety and efficacy have not been established. Further clinical studies are planned.
“The tailored targeting of the IL-36 pathway is one of the most exciting new areas in dermatology research, and progress in this mechanism has been eagerly anticipated by the scientific community,” commented the trial’s principal investigator, Professor Hervé Bachelez, Hôpital Saint-Louis, Paris, France. “This trial provides long-awaited clinical data that demonstrates the positive effect of blocking IL-36 action as a potential, novel treatment approach. The rapid improvement seen in patients from just a single dose of BI 655130 shows strong potential for the future treatment of GPP.”
The rare skin disease, GPP, is a chronic condition with a considerable impact on people’s quality of life.2 Estimates suggest a prevalence of 1-9 per 1,000,000.3 The skin becomes red and erupts into numerous blisters of non-infectious pustules, covering wide areas of the body.4,5,6 People who develop GPP experience an abrupt onset of fever, chills and painful skin lesions.4,5,6 GPP may be life-threatening and should be considered a medical emergency.7 Available treatment options for GPP have limited effectiveness, resulting in a need for new therapies for this rare but potentially life threatening condition.8
“BI 655130 is a novel antibody discovered by Boehringer Ingelheim and has the potential to transform the treatment of multiple inflammatory diseases,” said Dr Jan Poth, therapeutic area head, CNS and immunology at Boehringer Ingelheim.
“We are one of the first companies to focus on targeting IL-36 in dermatology, a reflection of our long-term commitment to researching and developing transformative medicines for patients where there is still high unmet need. Due to its potential, we are moving to the next phase of clinical trials, involving larger numbers of patients with GPP. Trials of BI 655130 are also underway in other immune related conditions, such as palmo-plantar pustulosis, ulcerative colitis, Crohn’s disease and atopic dermatitis,” continued Poth.
BI 655130 is the second compound developed by Boehringer Ingelheim’s immunology division. The first was risankizumab, an IL-23 blocker, which is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading future development and commercialisation of risankizumab globally.