Bertilimumab

Other

Bertilimumab

Bullous Pemphigoid

Preclinical Phase 1 Phase 2 Phase 3
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started

Bertilimumab

Ulcerative Colitis

Preclinical Phase 1 Phase 2 Phase 3
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started

Bertilimumab

Allergic Rhinitis

Preclinical Phase 1 Phase 2 Phase 3
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started

Bertilimumab

Allergic Conjunctivitis

Preclinical Phase 1 Phase 2 Phase 3
Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started

Bertilimumab, is a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that attracts eosinophils to the site of inflammation. By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells into inflamed tissues, thus helping to relieve associated conditions. Bertilimumab was shown to have biological activity in a variety of preclinical studies, with high affinity and specificity for human eotaxin-1, and was safe and well-tolerated in animal studies. It has been safely administered via intravenous, intranasal and topical ocular routes of administration with excellent tolerability.

There is a strong rationale to target eotaxin-1 in a variety of allergic and inflammatory diseases in which eosinophils play a role. Bertilimumab has shown clinical activity clinical trials in patients with allergic rhinitis and moderate-to-extensive bullous pemphigoid, and is currently being studies in patients with moderate-to-severe ulcerative colitis. Future development plans for bertilimumab include atopic dermatitis, asthma and other conditions.

Clinical Studies

Phase 2a Study in Bullous Pemphigoid

This trial was an open-label, single arm study that patients with moderate-to-extensive bullous pemphigoid at sites in the United States and Israel. The primary endpoint was safety and secondary endpoints included a variety of efficacy measures related to clinical signs and symptoms and tapering of systemic corticosteroids. Subjects in this study received bertilimumab IV at a dose of 10 mg/kg on days 0, 12 and 28 and were followed for a total of 84 days. In addition, they received a low dose of prednisone that was to be tapered rapidly, according to the subject's clinical status.

Of the 11 subjects enrolled, 9 received bertilimumab. Bertilimumab was well tolerated in all 9 subjects and no drug-associated serious adverse events were reported. Preliminary analyses demonstrated that the subjects in this study had an 81% decline in the Bullous Pemphigoid Disease Area Index (BPDAI) Total Activity Score. Moreover, the subjects in this study were able to show marked improvement in their disease despite an initial prednisone dose of 0.33 mg/kg that was reduced by over 50% by day 84. Results from this study were presented at the 2018 AAD as a late-breaker and at the 2018 pre-IID Pemphigus and Pemphigoid Symposium. The poster presented at the meeting can be found here.

Phase 2 Study in Ulcerative Colitis

This is a randomized, double blind, placebo-controlled trial seeking to enroll 42 adult patients with active moderate-to-severe UC. Subjects are randomized in a 2:1 ratio to receive bertilimumab or placebo. Subjects receive bertilimumab 10 mg/kg IV or placebo on days 0, 14 and 28, and are followed for safety and efficacy measures for 12 weeks. The primary endpoint is clinical response assessed by the Mayo Clinic Ulcerative Colitis Disease Index at 8 weeks. Secondary endpoints include assessment of mucosal injury and clinical remission.