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Immune begins two Phase II trials with bertilimumab to treat ulcerative colitis and bullous pemphigoid

US-based Immune Pharmaceuticals has started its Phase II ulcerative colitis clinical trial and is scheduled to begin its Phase II bullous pemphigoid clinical trial on 1 July with bertilimumab.

The company said that the study initiation is the training of hospital staff to allow for patient screening and immediate patient enrollment into the clinical trial upon selection.

The open label Phase II Bullous Pemphigoid clinical trial of bertilimumab will be carried out in ten patients, with moderate to severe Bullous Pemphigoid, an orphan chronic skin blistering disease.

The trial’s primary end points include safety and efficacy, measured by a reduction in clinical symptoms and tapering down of systemic corticosteroids.

Initial data from this trial is expected to be reported later this year or early 2016.

Immune R&D executive vice-president and chief medical officer Dr Paul Nadler said: "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 double blind placebo controlled Phase II ulcerative colitis trial of bertilimumab will be conducted in 42 patients, with moderate to severe disease.

Primary end points of this trial are safety and efficacy, measured by a reduction in the Mayo Clinic Ulcerative Colitis Disease Index at 8 weeks, while secondary end points include assessment of mucosal injury and clinical remission.

In this trial, patients are selected based on Mayo score and high levels of tissue eotaxin-1 as well as other standardized clinical criteria.

The completion of the clinical trial is expected by the end of next year.