Immune Pharmaceuticals Expands its Bertilimumab Phase II Clinical Trial in Bullous Pemphigoid to Six Academic Institutions in the United States
NEW YORK, June 14, 2016 /PRNewswire/ -- Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune"), a biopharmaceutical company focused on the development of targeted therapeutics for the treatment of inflammatory diseases and cancer, announced today that six academic clinical sites in United States for its BP-01 study are anticipated to be initiated over this summer. Immune has cleared a US IND and has received IRB approval from several sites for the intravenous use of bertilimumab, its anti-eotaxin monoclonal antibody, for the treatment of bullous pemphigoid (BP), an orphan inflammatory autoimmune disease manifest by blistering of the skin typically in older adults. The additional sites include University Hospitals Cleveland Medical Center, Mount Sinai in New York, Duke University, the University of Iowa, the University of Buffalo, and the University of Utah. This Phase II study has started enrolling patients in Israel earlier in 2016.
The overall incidence of BP is increasing with the aging of the population. There are currently approximately 60,000 BP patients in Europe and the U.S together. High dose oral corticosteroids (prednisone, 1 mg/kg/day) have been considered the mainstay of treatment for many years. However, such high corticosteroid doses are dangerous and have been linked to a high rate of side effects and an increase in mortality. Immunosuppressants are poorly tolerated in elderly BP patients, have failed to demonstrate a corticosteroid-sparing effect, and have revealed a higher rate of treatment-related side effects in patients receiving combined treatment compared with those treated with corticosteroid alone. There is therefore a significant need for novel and efficacious treatments.
Bertilimumab is Immune's first-in-class anti-eotaxin-1 monoclonal antibody that blocks eotaxin-1, which is a key driver of BP. Eotaxin-1 is an eosinophil-specific chemokine, which plays a role in both innate and adaptive immune responses and modulates the cross-talk between key cells involved in inflammation. Such personalized therapy aimed at a primary driver of disease process aims to optimize safety-to-efficacy ratio in the population by mitigating off-target effects of broad based non-selective immunomodulators. "It is very exciting to offer this unique targeted therapy to patients with bullous pemphigoid in the United States," said Dr. Neil Korman, MD, PhD, who is a scientific advisor for Immune's BP program, and is a Professor of Dermatology at Case Western University. "Bertilimumab has the potential to significantly reduce the risk of prolonged use of high-dose steroids, which these patients currently must rely on to manage their disease."
Bertilimumab is thought to provide an immunomodulatory treatment directed at a specific inflammatory pathway, with an anticipated safety profile advantage due to the selective nature of the treatment. Such precision therapies are designed to provide an optimized safety-to-efficacy ratio by selecting patients with higher response rates based on association of the disease with specific biomarkers. The results of this ongoing Phase II study may serve to inform further development in patients with BP.
About Immune Pharmaceuticals Inc.:
Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH (an inflammatory liver disease). Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's oncology pipeline includes Ceplene/IL-2 approved in Europe and Israel for maintenance remission in AML, Azixa and crolibulin, Phase II-ready vascular disrupting agents, and novel technology platforms; bispecific antibodies and targeted nanotherapeutics, NanomAbs. Immune's additional pipeline includes AmiKet Nano™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharmaceuticals.com, the content of which is not a part of this press release.
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