Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug
resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have
become more common. There is an urgent need for additional antibacterial drugs with modes of
action different from those currently available. CEM-102 is one such agent with excellent
activity against S. aureus, including MRSA.

Inclusion Criteria:

- Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days
duration which was suspected or proven to be caused, at least in part, by a
gram-positive pathogen.

- Eligible infections included cellulitis measuring at least 10 cm length and width or
100 cm squared, with or without a focal abscess, and surgical or traumatic wound
infections

- Infection which in the opinion of the investigator will require 10-14 days of
antibacterial therapy.

- Have at least 3 of the following local and/or systemic symptoms and/or signs of
infection: purulent or seropurulent drainage/discharge, erythema, fluctuance,
heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional
lymph node swelling or tenderness, temperature >=100.4 degree F, increased white
blood cell count, or bandemia.

- Must not have received treatment with another systemic antibiotic for the current
ABSSI.

Exclusion Criteria:

- Superficial skin structure infections such as folliculitis, carbuncles, furunculosis,
cutaneous abscesses, and simple cellulitis.

- Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.

- Suspected polymicrobial infection involving Pseudomonas aeruginosa

- Anticipated need for >14 days of antibiotic therapy.

- Infections complicated by the presence of prosthetic materials that will not be
removed, such as permanent cardiac pacemaker battery packs, mesh, or joint
replacement prosthesis.

- Known significant renal, hepatic, or hematologic impairment.

- Received prior potentially effective antimicrobial therapy for the acute bacterial
skin and skin structure infection, unless they were failing therapy after 48 hours or
had a gram-positive pathogen non-susceptible to prior therapy identified as a
causative pathogen.