Immune Pharmaceuticals Submits Investigational New Drug Application (IND) in the U.S. for its Lead Product Candidate Bertilimumab for the Treatment of Bullous Pemphigoid
Oct 7, 2015
NEW YORK, Oct. 7, 2015 /PRNewswire/ -- Immune Pharmaceuticals, Inc. (NASDAQ: IMNP) ("Immune" or the "Company") announced today that it has submitted an Investigational New Drug Application in the U.S. to expand recruiting for its first in class lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP).
Immune's U.S. IND application for the treatment of BP, a rare autoimmune skin disease known to have increased eotaxin-1 levels in serum and blister fluids. The U.S./EU BP patient population is estimated at 60,000 patients and is expected to grow to 90,000 patients by 2025.
Immune recently initiated a Phase IIa open label clinical trial in BP in Israel. This study is designed to recruit 10-15 patients diagnosed with moderate to severe BP in order to evaluate symptomatic improvement and reduction in the use of steroids. Upon approval of the IND, Immune will have the opportunity to treat BP patients in clinical trials conducted in the U.S.
"Submitting a U.S. IND application will allow Immune, once approved, to include leading U.S. academic medical centers. We believe that Bertilimumab's biologic activity supports further clinical development not only in BP but in other immuno-dermatology indications such as severe atopic dermatitis," stated Dr. Daniel Teper, CEO of Immune Pharmaceuticals.
About Immune Pharmaceuticals:
Immune Pharmaceuticals 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 clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan auto-immune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and NASH (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 pipeline also includes NanomAbs®, antibody nano-conjugates, for the targeted delivery of chemotherapeutics. Immune's non-core pipeline includes AmiKet™, a late clinical stage drug candidate for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharmaceuticals.com
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SOURCE Immune Pharmaceuticals, Inc.
For further information: Christine J. Petraglia, Director Investor Relations, Immune Pharmaceuticals, (646) 440-9332