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Boehringer Ingelheim present data showing that their "BI 655130" a monoclonal antibody that blocks the action of the interleukin-36 receptor (IL-36R) showed significantly improved symptoms of generalised pustular psoriasis.
Source: boehringer-ingelheim.com
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New data from a Phase I clinical trial showed BI 655130, a first-in-class investigational treatment, significantly improved symptoms of generalised pustular psoriasis (GPP), a rare form of psoriasis.
BI 655130 is a monoclonal antibody that blocks the action of the interleukin-36 receptor (IL-36R), a signalling pathway within the immune system that may play a role in many inflammatory diseases.
The newly published clinical data, indicate that BI 655130 rapidly improved symptoms in seven patients with GPP, who were experiencing acute moderate or severe disease flares. Five of seven patients in the 20-week, Phase I clinical trial achieved clear or almost clear skin within the first week, following a single dose of treatment, and all patients achieved this outcome after four weeks. The average improvement in patients’ skin symptoms was close to 80 per cent at week four and was maintained until the end of the study (week 20).
“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 show strong potential for the future treatment of GPP.”
The rare skin disease, GPP, is a chronic condition that is distinct from the more common condition, plaque psoriasis. It has a considerable impact on people’s quality of life. The skin becomes red and erupts into numerous blisters of non-infectious pus (pustules), covering wide areas of the body. People who develop GPP may experience an abrupt onset of fever, chills and painful skin lesions. GPP may be associated with life-threatening organ failure and infectious complications, and, therefore, should be considered a medical emergency. Available treatment options for GPP are extremely limited and lack profound and persistent efficacy. Therefore, there is a strong need for new treatment options for GPP with rapid, strong and persistent efficacy.
“BI 655130 is a novel antibody discovered by Boehringer Ingelheim and is being investigated for the treatment of multiple inflammatory diseases in the hope of transforming the care currently available for these patients,” 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.
Source: boehringer-ingelheim.com