FDA accepts investigational new drug application for bertilimumab for bullous pemphigoid

Immune Pharmaceuticals announced in a press release that the FDA has accepted its investigational new drug application for bertilimumab for treating bullous pemphigoid.

The FDA action allows Immune Pharmaceuticals to expand recruitment for clinical trials of its product candidate, according to the release. Bullous pemphigoid, an orphan autoimmune skin disease associated with increased eotaxin-1 levels in serum and blister fluids, has an estimated patient population of 60,000 in the United States and European Union, primarily affecting the elderly, the release reported.

“Bullous pemphigoid has no real treatments beyond … corticosteroids,” Neil Korman, MD, PhD, professor of dermatology, University Hospitals, Case Medical Center, Cleveland, said in the release. “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.”

Immune recently initiated a phase 2a open label clinical trial in Israel, which is to recruit 10 to 15 patients diagnosed with moderate to severe bullous pemphigoid in order to evaluate symptomatic improvement and reduction in the use of steroids. Immune also has the possibility of treating patients with bullous pemphigoid in U.S. clinical trials at centers including Mt. Sinai School of Medicine in New York, according to the release.

“We are ready to expand our trials in the U.S., and in Europe, subject to regulatory acceptance there,” Daniel Teper, PharmD, MBA, CEO of Immune Pharmaceuticals, stated in the release. “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.”

Reference: www.immunepharma.com