EARLY AND EFFECTIVE CLINICAL SUCCESS IN ABSSSI

OASIS-1 study design (N=655)1,2

  • OASIS-1, known as Trial 2 in the NUZYRA Prescribing Information, was a randomized, multicenter, multinational, double-blind, double-dummy trial comparing the noninferiority of 7 to 14 days of NUZYRA to linezolid.

    —

    Types of infections included: wound infection, cellulitis, and major abscess

  • NUZYRA was administered in 100 mg doses intravenously every 12 hours for 2 doses followed by 100 mg doses intravenously every 24 hours, with the option to switch to 300 mg orally every 24 hours. Linezolid was administered in 600 mg doses intravenously every 12 hours, with the option to switch to 600 mg orally every 12 hours

Clinical success in ABSSSI: IV to Oral

NUZYRA® IV to oral - mITT population early clinical response (mITT-ECR) 48-72 hours after first dose
NUZYRA® IV to oral - mITT population post therapy evaluation (mITT-PTE) 7-14 days after last dose
NUZYRA® IV to oral - CE population post therapy evaluation (CE-PTE) 7-14 days after last dose

ENDPOINTS1,2

  • Primary endpoint at ECR (early clinical response, 48 to 72 hours postinitiation of treatment) in the mITT population was defined as a ≥20% decrease in lesion size, without receiving any rescue antibacterial therapy*
  • Secondary endpoint at PTE (post therapy evaluation, 7 to 14 days after last dose) was defined as survival after completion of study treatment without receiving any other antibacterial therapy or unplanned major surgical intervention, and having sufficient resolution of infection such that further antibacterial therapy is not needed, and the infection was considered clinically cured. The secondary endpoint was evaluated in the mITT and in the CE populations

  1. *Reasons for failure included: <20% reduction in lesion size, administration of rescue antibacterial therapy, use of another antibacterial or surgical procedure to treat for lack of efficacy, or death.1

STUDY POPULATIONS1,2

  • Modified intent-to-treat (mITT) population was defined as all randomized patients without a sole Gram-negative causative pathogen at screening, due to the lack of Gram-negative activity of linezolid
  • Clinically evaluable (CE) population was defined as mITT patients who met inclusion criteria and completed the trial, with a PTE visit 7 to 14 days after the last dose
  • Microbiological mITT (micro-mITT) population was defined as all patients in the mITT population who had at least 1 Gram-positive causative pathogen identified at baseline

OASIS-2 study design (N=735)1,2

  • OASIS-2, known as Trial 3 in the NUZYRA PI, was a randomized, multicenter, multinational, double-blind, double-dummy trial comparing the noninferiority of NUZYRA to linezolid

    — Types of infections included: wound infection, cellulitis, and major abscess

  • NUZYRA was administered in a 450 mg oral dose once a day on Days 1 and 2, followed by 300 mg orally once a day. Linezolid was administered in 600 mg oral doses every 12 hours

Clinical success in ABSSSI: Oral only

NUZYRA® oral only - mITT population early clinical response (mITT-ECR) 48-72 hours after first dose
NUZYRA® oral only - mITT population post therapy evaluation (mITT-PTE) 7-14 days after last dose
NUZYRA® oral only - CE population post therapy evaluation (CE-PTE) 7-14 days after last dose

ENDPOINTS1,2

  • Primary endpoint at ECR (early clinical response, 48 to 72 hours postinitiation of treatment) in the mITT population was defined as a ≥20% decrease in lesion size, without receiving any rescue antibacterial therapy*
  • Secondary endpoint at PTE (post therapy evaluation, 7 to 14 days after last dose) was defined as survival after completion of study treatment without receiving any other antibacterial therapy or unplanned major surgical intervention, and having sufficient resolution of infection such that further antibacterial therapy is not needed, and the infection was considered clinically cured. The secondary endpoint was evaluated in the mITT and in the CE populations

  1. *Reasons for failure included: <20% reduction in lesion size, administration of rescue antibacterial therapy, use of another antibacterial or surgical procedure to treat for lack of efficacy, or death.1

STUDY POPULATIONS1,2

  • Modified intent-to-treat (mITT) population was defined as all randomized patients without a sole Gram-negative causative pathogen at screening, due to the lack of Gram-negative activity of linezolid
  • Clinically evaluable (CE) population was defined as mITT patients who met inclusion criteria and completed the trial, with a PTE visit 7 to 14 days after the last dose
  • Microbiological mITT (micro-mITT) population was defined as all patients in the mITT population who had at least 1 Gram-positive causative pathogen identified at baseline

CLINICAL SUCCESS RATES BY PATHOGEN AT PTE IN ABSSSI1,a

PATHOGEN NUZYRA

% (n/N)

 LINEZOLID

% (n/N)
Staphylococcus aureus 83% (305/369) 81% (306/378)
Methicillin-susceptible Staphylococcus aureus (MSSA) 82% (164/201) 80% (181/226)
Methicillin-resistant Staphylococcus aureus (MRSA) 84% (146/173) 82% (128/157)
Staphylococcus lugdunensis 91% (10/11) 67% (2/3)
Streptococcus anginosus group 81% (84/104) 72% (59/82)
Streptococcus pyogenes 70% (28/40) 74% (25/34)
Enterococcus faecalis 94% (17/18) 84% (21/25)
Enterobacter cloacae 79% (11/14) 82% (9/11)
Klebsiella pneumoniae 73% (8/11) 55% (6/11)

aInvestigator’s overall assessment of clinical response at PTE by baseline pathogen in OPTIC (micro-ITT population).