The New England Journal of Medicine recently published new data from a Phase I clinical trial suggesting that BI 655130, a first-in-class investigational treatment, significantly improved symptoms of generalized 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 signaling pathway within the immune system that may play a role in many inflammatory diseases.

The clinical data, which were also presented at the recent American Academy of Dermatology (AAD) annual meeting in Washington, DC, indicate that BI 655130 rapidly improved symptoms in seven patients with GPP, who were experiencing acute, moderate-to-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 4 weeks. The average improvement in patients’ skin symptoms was close to 80% at week four and was maintained until the end of the study (week 20), explains a media release from Boehringer Ingelheim.

“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 trial’s principal investigator, Professor Hervé Bachelez, Hôpital Saint-Louis, Paris, France, comments in the release.

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. In the US, there are no FDA approved treatments for GPP. Therefore, there is a strong need for new treatment options for GPP with rapid, strong and persistent efficacy, the release explains.

“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,” states Dr Jan Poth, Therapeutic Area Head, CNS and Immunology at Boehringer Ingelheim.

Study Details

The Phase I trial is the first of its kind to include patients who were experiencing an acute, moderate-to-severe flare of GPP, the release suggests.

Each of the seven patients received a single intravenous dose of BI 655130 and was monitored for 20 weeks. The severity of GPP was assessed using the Generalized Pustular Psoriasis Physician Global Assessment score and the Generalized Pustular Psoriasis Area and Severity Index score.

  • At the end of week one, clear or almost clear skin was achieved in five of seven patients, and in all study participants by the fourth week.
  • At the end of week two, a 73.2 percent average improvement in skin symptom was observed in all study participants.
  • Overall, BI 655130 was well tolerated with no drug-related severe or serious adverse events or safety signals.

[Source(s): Boehringer Ingelheim, PR Newswire]