Positive Preliminary Phase 2 Data for Bertilimumab in Bullous Pemphigoid Treatment

Preliminary results demonstrate positive data from the first 6 subjects in an ongoing, open-label phase 2 study of bertilimumab in patients with moderate to severe bullous pemphigoid (BP), announced Immune Pharmaceuticals, Inc.

In February 2017, the company reported results from the first 3 subjects, and the latest results from 3 new subjects confirm and extend previous findings.

“These results are quite impressive,” Dr. Neil Korman, professor of dermatology at the Case Western Reserve University School of Medicine, chair of Immune’s Scientific Advisory Board, said. “If bertilimumab can substantially reduce or perhaps even eliminate the need for systemic corticosteroids in the treatment of bullous pemphigoid and their significant toxicity in this elderly population, it will be a major step forward in the management of what is the most common blistering disease.”

The 6 subjects experienced a decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Total Activity Score of 85%. The mean BPDAI Total Activity Score decline from a baseline of 56 to 10, by final assessment on day 84 — except for 1 subject who enrolled under the original protocol with a final assessment on day 56.

Subjects experienced rapid improvement, with a mean decline in the BPDAI Total Activity Score of 72% achieved by day 42. Greater than a 50% reduction in patients’ BPDAI Total Activity Score by the final assessment was achieved, and 4 of the 6 patients underwent a reduction greater than 90%.

Bertilimumab was well tolerated and no serious adverse events were reported.

The company will continue enrollment in the study with a target of 12—15 patients.

The company noted a key goal of the trial is to limit steroid exposure, as all 6 subjects experienced rapid improvement despite a low initial steroid dose and rapid taper. As of the last follow-up, 5 of the 6 subjects were receiving a prednisone of 10 mg or less.

Bertilimumab is a first-in-class, humanized monoclonal antibody targeting and lowering levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation.

Once neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, relieving associated inflammatory conditions.

Immune Pharmaceuticals is currently holding another clinical trial to test bertilimumab in patients suffering from ulcerative colitis. Bertilimumab may have application in other diseases like NASH, atopic dermatitis, immune and inflammatory hepatitis and asthma.