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.
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