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Phase 2 clinical trials underway in ulcerative colitis, bullous pemphigoid
Immune Pharmaceuticals announced initiation of two phase 2 studies looking at bertilimumab in ulcerative colitis and bullous pemphigoid.
“We believe that bertilimumab is a promising first in class monoclonal antibody with the potential to treat multiple inflammatory diseases,” Paul I. Nadler, MD, FCP, FACP, executive vice president of research and development and chief medical officer of Immune Pharmaceuticals, said in the press release. “It targets eotaxin-1, which is also a biomarker of disease severity, supporting a personalized medicine and companion diagnostic strategy.”
The ulcerative colitis phase 2 clinical trial will be a double-blind, placebo-controlled study in 42 patients who have moderate to severe ulcerative colitis, according to the release. Patients will be chosen based on Mayo Clinic Ulcerative Colitis Disease Index score and high levels of eotaxin-1 along with other clinical criteria. Primary endpoints are set as safety and efficacy, which will be evaluated using the Mayo Clinic index at 8 weeks to determine if there was a reduction. Secondary endpoints will include mucosal injury assessment and clinical remission. Trial completion is expected by the end of 2016.
The scheduled phase 2 study in bullous pemphigoid will be an open label trial in 10 patients with moderate to severe bullous pemphigoid, an orphan disease of chronic skin blistering. Primary endpoints include safety and efficacy, which will be evaluated by clinical symptom reduction and lessening of systemic corticosteroids. According to the release, data is expected initially in late 2015 or early 2016.
“The first two phase 2 clinical trials with bertilimumab in bullous pemphigoid and ulcerative colitis are expected to provide guidance on further clinical development,” Nadler said.
Disclosure: Nadler reports he is an employee of Immune Pharmaceuticals.