Immune Pharmaceuticals begins patient screening for Bertilimumab Phase II clinical trial in Bullous Pemphigoid

This open-label trial will enroll 10-15 patients who will receive two bertilimumab infusions, at a dose of 10 mg/kg, on days 0 and 14. Patients will also start concomitant treatment with an initial moderate dose of oral prednisone (30 mg daily) to be tapered down rapidly starting as early as week 1 based on patient response.

Patients will be followed for eight weeks with primary efficacy end points focused on disease control measured by the Bullous Pemphigoid Disease Area Index, a validated index developed by international experts in this indication, and steroid sparing, the proportion of patients who achieve a steroid dose of = 10 mg daily at the end of follow up.

The study principal investigator is Eli Sprecher, M.D., Ph.D., Professor of Dermatology, Sackler Faculty of Medicine, Tel Aviv University, and Chairman of the Department of Dermatology at the Sourasky Medical Center in Tel Aviv, Israel.

Dr. Daniel Teper, Chairman and CEO of Immune comments: "Following the announcement last week of our partnership with Lyfebulb, and future collaborative activities with the International Pemphigus and Pemphigoid Foundation (IPPF), we are pleased to announce the commencement of patient screening in a Phase II bullous pemphigoid clinical trial with bertilimumab. We will continue to work closely with key opinion leaders, patient advocacy organizations and regulatory authorities to design a clinical development program that we believe will help bring needed new options for patients with bullous pemphigoid."