Immune Pharmaceuticals Inc., a company currently developing novel, highly-targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer, recently announced the initiation of a Phase II Ulcerative Colitis trial and the schedule of the initiation of a Phase II Bullous Pemphigoid trial on July 1, 2015. The initiation of the study allows for patient screening and enrollment into the study upon selection.
Paul I. Nadler, MD, FCP, FACP Executive Vice President, R&D and Chief Medical Officer of Immune Pharmaceuticals, commented in a recent press release, “We believe that bertilimumab is a promising first in class monoclonal antibody with the potential to treat multiple inflammatory diseases. It targets eotaxin-1, which is also a biomarker of disease severity, supporting a personalized medicine and companion diagnostic strategy. The first two Phase II clinical trials with bertilimumab in Bullous Pemphigoid and Ulcerative Colitis are expected to provide guidance on further clinical development.”
The Phase II Ulcerative Colitis study of bertilimumab is a double blind placebo controlled clinical study involving 42 patients, who suffer from moderate to severe Ulcerative Colitis (UC), a chronic condition causing ulcers and inflammation in the digestive tract. According to a Global Data Report, the condition affects about 2 million people worldwide. The study endpoints include the efficacy and safety assessed through decrease in the Mayo Clinic Ulcerative Colitis Disease Index following 8 weeks of treatment.
The study’s secondary endpoints are clinical remission and mucosal injury assessment. For the study, patients are chosen based on Mayo Index results, high levels of tissue eotaxin-1 and other clinical criteria. The study s expected to be complete in the end of 2016.
Results from a recent Vanderbilt study, published in the journal PlosOne and funded by the National Institute of Health, showed a correlation between severity of the disease, disease activity in UC patients and tissue eotaxin-1 levels. The researchers suggested that the study results show that the assessment of eotaxin-1 is useful to choose patients for treatment with bertilimumab.
Bertilimumab is a fully human, IgG4-type monoclonal antibody (mAb) that blocks the activity of a protein called eotaxin-1 that plays an important role in inflammation in multiple clinical indications.
Eotaxin-1 causes eosinophils (a type of white blood cell involved in inflammation and allergy) to migrate towards sites of inflammation where they become activated and release substances that result in tissue damage and enhance inflammation. By blocking the effects of eotaxin-1 on eosinophil function, Bertilimumab is a promising clinical stage candidate for a variety of inflammatory conditions, including Ulcerative Colitis, Crohn’s disease, Severe Asthma and Bullous Pemphigoid.