PracticeUpdate Conference Series: IID 2018

Results of Two Studies Point to Potential Treatments for Alopecia Areata The selective interleukin 2/9/15 inhibitor BNZ-1 has shown promise as a therapy for alopecia areata, reports a preclinical and a clinical study presented at IID 2018.

BNZ-1 P aul Frohna, MD, PhD, PharmD, of Bioniz in Irvine, California, explained that immune pathways required for autoreactive T cell activation in alopecia areata have been recently proposed to involve the common γ chain cytokines interleukins 2, 9, and 15. These interleu- kins have been shown to be upregulated in animal models of alopecia areata and in human biopsies of alopecia areata lesions. BNZ-1 is a PEGylated peptide that binds to the γ chain receptor and selectively inhib- its interleukin 2, 9, and 15 signaling. This inhibition shuts off the JAK-STAT/P13K/Akt/ mTOR and Raf/ERK/MAPK pathways.

BNZ-1 has exhibited efficacy in reversing hair loss in a humanized mouse model of alopecia areata. BNZ-1 has undergone extensive preclinical safety testing to initiate an investigational new drug appli- cation with the FDA. BNZ1-CT-102 was a randomized, single-blind, placebo-controlled, multiple-dose study that characterized the safety, pharmacokinetics, and pharmacodynamics of intravenous BNZ-1 administered to healthy adults (n=5 per dose) once weekly at 0.5, 1, or 1.5 mg per kilogram of body weight. Overall safety was good, with no serious or severe adverse effects, infusion reac- tions, or dose-limiting toxicity observed. In all, 11 of 24 patients (46%) who received BNZ-1 experienced at least 1 adverse effect. A total of 19 adverse effects were reported. A total of 3 of 7 (43%) patients administered placebo experienced at least 1 adverse effect, with 9 adverse effects reported. Adverse effects that occurred in more than 1 BNZ-1-treated subject were

Dr. Paul Frohna

" …strong associations were shown between alopecia areata and mental health disorders and emergencies in this cohort of hospitalized patients. "

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PRACTICEUPDATE CONFERENCE SERIES • IID 2018