Date: 2015-11-09
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the Annual Meeting of the American College of Rheumatology (ACR)
Company: AB2 Bio (Switzerland)
Product: interleukin-18 binding protein (IL-18BP)
Action
mechanism: protein. IL-18BP is a human protein with a high affinity for IL-18, amajor inflammatory cytokine. In healthy people, there is a large excess of naturally occurring IL-18BP keeping levels of free IL-18 low. However, in patients with certain inflammatory diseases, the IL-18/IL-18BP balance is disrupted, resulting in high levels of free and active IL-18, which in turn leads to pathological inflammation. Administration of AB2 Bio’s exogenous recombinant human IL-18BP restores the IL-18/IL-18BP balance, removing free IL-18 and thereby reducing inflammation. AB2 Bio has developed the first proprietary assay detecting free IL-18 allowing the identification of clinical entities that are driven by free IL-18. As patients with high levels of free IL-18 can be identified, the clinical impact of treatment with IL-18BP will be maximized. The patients unlikely to respond to the treatment will not be unnecessarily exposed to ineffective medicines. Extensive Phase I and Ib clinical trial results have demonstrated that IL-18BP is very well tolerated and has an excellent safety profile.AB2 Bio is currently conducting a Phase II clinical trial in patients with Adult onset Still’s disease.
Disease: systemic inflammation
Therapeutic area: Inflammatory diseases
Country: USA
Trial details:
Latest
news: * On November 9, 2015, AB2 Bio announced a medical breakthrough in the treatment of severe systemic inflammation with its AB2 Bio Ltd, located on the Innovation Park at the École polytechnique fédérale de Lausanne (EPFL), Switzerland, is specialised in the development of treatments against inflammatory diseases. The company is currently in a Series B financing round.
experimental drug, Interleukin-18 Binding Protein (IL-18BP). A critically ill baby girl with major systemic inflammation was successfully treated in summer 2015 with IL-18BP on a compassionate use basis. In September, it was reported that she has entered into full remission. This extraordinary case report will be presented at the Annual Meeting of the ACR in San Francisco, CA on November 9, 2015.
In May 2015, a Physician, based at the Children’s Hospital of Philadelphia, who was treating a critically ill baby girl, asked AB2 Bio Ltd to provide IL-18BP on a compassionate use basis. At that timethe baby was 3 months old and had major systemic inflammation. Her chances of survival were considered small as she was suffering from severe enterocolitis (inflammation of the colon). Genotyping of the baby demonstrated that she had a recently identified, potentially fatal, genetic mutation of the NOD-like receptor C4 (NLRC4) gene. This mutation is associated with extremely high levels of IL-18, the therapeutic target of AB2 Bio. With the help of the company, the treating physician submitted a Compassionate Use Investigational New Drug (IND) Application to the FDA. The treatment was initiated in June 2015 and she rapidly responded with her symptoms resolving. Early August 2015 she was discharged from hospital. Although she is still being treated with IL-18BP, she is now at home with her parents and has entered into full remission.
