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news.The US Food and Drug Administration (FDA) accepted Immune Pharmaceuticals' investigational new drug (IND) application for Bertilimumab to treat bullous pemphigoid, a skin disease that tends to affect the elderly.
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Bullous pemphigoid is known to be associated with increased eotaxin-1 levels in serum and blister fluids.
Immune recently started a Phase IIa open label clinical trial in bullous pemphigoid in Israel at the Tel Aviv University School of Medicine.
Under the study, the company plans to enroll 10 to 15 patients diagnosed with moderate to severe bullous pemphigoid in order to assess symptomatic improvement and reduction in the use of steroids.
The FDA approval allows the company to undertake the clinical trials in the US in three planned centers.
Immune Pharmaceuticals CEO Daniel Teper said: "The IND acceptance enables Immune to include leading U.S. academic medical centers in our clinical trial program. We are ready to expand our trials in the U.S., and in Europe, subject to regulatory acceptance there.
"Access to a larger number of centers also allows the Company to receive feedback on Bertilimumab from key opinion leaders and we believe may allow accelerated patient recruitment."
The bullous pemphigoid patient population in the US and EU is estimated at 60,000 patients and is projected to increase to 90,000 patients by 2025.