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AnaptysBio Announces Positive Rosnilimab Healthy Volunteer Phase 1 Top-Line Data
Rosnilimab, AnaptysBio’s wholly-owned anti-PD-1 agonist antibody, demonstrated favorable safety and tolerability in single and multiple ascending dose healthy
About this update from Anaptysbio, Inc.
[{"type":"text","content":"Rosnilimab, AnaptysBio’s wholly-owned anti-PD-1 agonist antibody, demonstrated favorable safety and tolerability in single and multiple ascending dose healthy volunteer cohortsRobust pharmacokinetic profile, in conjunction with rapid and sustained PD-1 receptor occupancyPharmacodynamic activity resulted in dose-dependent reduction of PD-1+ T cells and antigen-specific immune response, which we believe supports rosnilimab’s potential to treat T-cell driven human inflammatory diseasesData support monthly subcutaneous rosnilimab dosing in upcoming AZURE Phase 2 placebo-controlled clinical trial in moderate-to-severe alopecia areata patients SAN DIEGO, Nov. 15, 2021 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced positive top-line data from a randomized placebo-controlled healthy volunteer single and multiple ascending dose Phase 1 trial of rosnilimab, its investigational wholly-owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030. Top-line data demonstrated favorable safety, pharmacokinetics and pharmacodynamic results that support advancement of rosnilimab into subsequent patient trials. “Agonizing the inhibitory function of PD-1 is an exciting new approach to T cell modulation,” said Dr. W. Michael Gallatin, leading anti-inflammatory drug development expert and member of AnaptysBio’s Research and Development Committee. “These data support rosnilimab’s potential to specifically target the subset of T cells expressing PD-1 which are believed to be key drivers of human autoimmune and inflammatory diseases.” “We are pleased to report promising results for rosnilimab in this healthy volunteer Phase 1 trial,” said Dr. Paul F. Lizzul, chief medical officer of AnaptysBio. “We believe rosnilimab’s mechanism is broadly applicable to T cell driven inflammatory diseases and look forward to initiating our AZURE moderate-to-severe alopecia areata trial.” A total of 144 subjects were enrolled in the randomized, double-blind, placebo-controlled healthy volunteer Phase 1 trial, where single ascending dose (SAD) cohorts were administered single subcutaneous or intravenous doses of rosnilimab ranging between 0.02...