XBONZY® demonstrated bioequivalence to reference product with no clinically meaningful differences across subgroups, including PK parameters2

Randomized, double-blind, multicenter study Study participation = 32 weeks

Efficacy
  • Two-arm, parallel-group study
  • N = 208 healthy males
  • Comparable mean serum concentration–time profiles for XBONZY® and RP.2
  • No notable differences
    in subgroups.2
  • Comparable additional PK parameters across treatment groups.2

PK: pharmacokinetic; RP: Reference Product; D: day; EoS: end of study; SC: subcutaneous; W: week

XBONZY® demonstrated a comparable safety profile to the reference product in both the severity and incidence of TEAEs2

  • Comparable overall
    incidence of adverse events2
  • Comparable % of most common TEAEs2
  • Comparable
    immunogenicity profile2
  • No TEAEs leading to treatment
    discontinuation or deaths.2
  • ISRs were reported in 5 (4.8 %)
    participants in both groups.2
  • A similar number or participantsin both
    treatment groups experienced TEAEs:2

HEADACHE

UPPER RESPIRATORY
TRACT INFECTION

NASOPHARYNGITIS

  • Similar onset and development of both ADAs and neutralizing antibodies over time across both treatment groups.2
  • The trend in the safety data based on immunogenicity subgroups was consistent in both XBONZY® and RP groups.2
  • Two-arm, parallel-group study
  • N = 208 healthy males
  • Randomized, double-blind, multicenter study

TEAE: Treatment-Emergent Adverse Event; RP: Reference Product; ISR: Injection Site Reaction; ADAs: anti-drug antibodies.