Immune Pharmaceuticals: FDA Accepts IND Application for Bertilimumab for Bullous Pemphigoid


Immune Pharmaceuticals, Inc. has indicated that the FDA has 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. 

"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.

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 U.S. in three planned centers, including Mt. Sinai School of Medicine in New York under the direction of Annette Czernik, MD, Clinical Director of Dermatology.

Facebook Comments


We’re glad to see you’re enjoying PracticalDermatology…
but how about a more personalized experience?

Register for free