The US Food and Drug Administration (FDA) has accepted Immune Pharmaceuticals’ investigational new drug (IND) application for its first in class, lead product candidate, bertilimumab, to treat Bullous Pemphigoid (BP).
The FDA acceptance allows the company to expand recruitment for its clinical trials.
BP is an orphan autoimmune skin disease known to be associated with increased eotaxin-1 levels in serum and blister fluids.
Currently, the BP patient population is estimated to be 60,000 patients in the US and EU, which is expected to increase to 90,000 patients by 2025.
University Hospitals, Case Medical Center Dermatology professor Neil Korman said: “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.”
The company has also started a Phase IIa open label clinical trial in BP in Israel at the Tel Aviv University School of Medicine.
Around 10-15 patients, diagnosed with moderate to severe BP, will be enrolled in the trial to evaluate symptomatic improvement and reduction in the use of steroids.
The company currently 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 Dermatology clinical director Annette Czernik.
Immune Pharmaceuticals CEO Dr Daniel Teper said: “The IND acceptance enables Immune to include leading US academic medical centres in our clinical trial programme.
“We are ready to expand our trials in the US, and in Europe, subject to regulatory acceptance there. Access to a larger number of centres also allows the company to receive feedback on bertilimumab from key opinion leaders and we believe may allow accelerated patient recruitment.”
Recently, the company has expanded its portfolio in immuno-dermatology with topical nano-formulated Cyclosporine A to treat psoriasis and atopic dermatitis.
Immune’s pipeline also includes NanomAbs, antibody nano-conjugates, for the targeted delivery of chemotherapeutics.