Immune Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). This FDA acceptance enables the company to expand recruitment for its clinical trials.
Immune's IND application is for the treatment of BP, an orphan autoimmune skin disease known to be associated with 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. Most diagnosed patients are elderly, and BP, along with other conditions, impacts daily life extensively.
"An autoimmune blistering disease, Bullous Pemphigoid, has no real treatments beyond powerful anti-inflammatory medicines called corticosteroids. Yet, for patients with suppressed immune systems, steroids may not be a long-term treatment option. We believe that regulating eotaxin-1 levels may provide patients with much needed relief," said Neil Korman, MD, PhD, professor of dermatology, University Hospitals, Case Medical Center, Cleveland, OH.
Immune recently initiated a phase IIa open label clinical trial in BP in Israel at the Tel Aviv University School of Medicine. This trial 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. Immune now has the opportunity to treat BP patients in clinical trials conducted in the US in three planned centres, including Mt. Sinai School of Medicine in New York under the direction of Annette Czernik, MD, clinical director of dermatology.
"The IND acceptance enables Immune to include leading US academic medical centres in our clinical trial program. We are ready to expand our trials in the US, 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," stated Dr. Daniel Teper, CEO of Immune Pharmaceuticals.
"Bullous Pemphigoid patients are generally elderly, and they suffer from blistering and often severe pain, itching, burning and stinging. This chronic illness needs treatments, and we are gratified that Immune is committed to advancing clinical understanding developing a treatment," said William J. Zrnchik II, M.B.A., M.N.M., chief executive officer, International Pemphigus & Pemphigoid Foundation.