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Immune’s bertilimumab yields positive results in phase 2 bullous pemphigoid trial

PBR Staff Writer Published 28 September 2017

Immune Pharmaceuticals has reported that its ongoing phase 2 trial of bertilimumab in patients with moderate to severe bullous pemphigoid (BP) has yielded positive results.

The New York-based biopharmaceutical company said that the preliminary results were observed from the first six subjects enrolled in the open-label trial dubbed NCT02226146.

Immune Pharmaceuticals stated that the six patients had shown a reduced bullous pemphigoid activity that was large and statistically significant. This, it said had come about despite aggressive prednisone tapering while resulting in no serious adverse events.

All the six participants in the trial experienced a decline by 85% from baseline in symptoms as measured by the Bullous Pemphigoid Disease Area Index (BPDAI) scale.

Bullous pemphigoid is a rare dermatological auto-immune blistering disease of the skin which affecting mostly people who are over 60 years old. Immune Pharmaceuticals stated that the skin disease affects 30,000 Americans and an estimated 90,000 people globally.

The phase 2 trial is investigating 10 mg/kg of Bertilimumab in physiological solution (PBS) given as an intravenous injection over 30 minutes.

The results from three new subjects confirm and extend previous findings of bertilimumab that were released in February from the first three subjects enrolled in the trial.

Immune Pharmaceuticals president and CEO Elliot Maza said: “These promising preliminary results support our strategy of focusing our human capital and financial resources on our bertilimumab and NanoCyclo product candidates while streamlining our operations by divesting our unrelated oncology business.

“We will continue to enroll subjects into this phase 2 open label BP trial, which has a target enrollment of 12 to 15 patients, as we initiate plans for a larger clinical trial designed to prove that bertilimumab provides a significant benefit to patients suffering from this severe inflammatory disease.”

Immune Pharmaceuticals develops novel therapeutic agents for the treatment of immunologic and inflammatory diseases.

Image: Immune’s bertilimumab registered positive top-line results in a phase 2 trial. Photo: courtesy of jk1991/