Immune Pharmaceuticals Inc. (NASDAQ: IMNP) announced today that it has initiated its Phase II Ulcerative Colitis clinical trial and is scheduled to initiate its Phase II Bullous Pemphigoid clinical trial on July 1, 2015. Study Initiation is the training of hospital staff to allow for patient screening and immediate patient enrollment into the clinical trial upon selection.
Paul I. Nadler, MD, FCP, FACP Executive Vice President, R&D and Chief Medical Officer of Immune Pharmaceuticals, commented, "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 bertilimumab Phase II Bullous Pemphigoid clinical trial is designed as an open label clinical trial in 10 patients, with moderate to severe Bullous Pemphigoid. Bullous Pemphigoid is an orphan chronic skin blistering disease affecting around 60,000 people globally, mostly in the elderly population, according to a Chardan Capital report. Primary end points include safety and efficacy, measured by a reduction in clinical symptoms and tapering down of systemic corticosteroids. Initial data is expected in late 2015 or early 2016.
The bertilimumab Phase II Ulcerative Colitis clinical trial is designed as a double blind placebo controlled trial in 42 patients, with moderate to severe disease. Ulcerative Colitis is a chronic inflammatory bowel disease (IBD) that causes long-lasting inflammation and ulcers in the digestive tract and affects around 2 million people worldwide according to a Global Data Report. Primary end points are safety and efficacy, measured by a reduction in the Mayo Clinic Ulcerative Colitis Disease Index at 8 weeks. Secondary end points include assessment of mucosal injury and clinical remission. 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 is expected by the end of 2016.
A Vanderbilt study, sponsored by the National Institute of Health, and published in PlosOne (PLoS One. 2013 Dec 18;8(12)) showed a statistically significant correlation between tissue eotaxin-1 levels and severity of the disease as well as disease activity in ulcerative colitis patients. The authors concluded that their data implicates eotaxin-1 as an etiologic factor and therapeutic target in UC, and that eotaxin-1 measurement may be useful to select patients for therapy with bertilimumab.
The first Immune Pharmaceuticals R&D day will take place on September 8, 2015 at the Alexandria Center for Life Science in New York City.
Immune management and several Key Opinion Leaders will outline Immune's R&D strategy and development plans, including the following:
- Bertilimumab 2016 clinical development plan expansion with a second double blind placebo controlled bullous pemphigoid clinical trial and pilot clinical trial in liver diseases (NASH) and severe asthma;
- Development plan for topical nano-formulated cyclosporine A in psoriasis and atopic dermatitis; and
- Development for NanomAbs in oncology.
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