Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the
pleuromutilins. The oral dosage form of lefamulin is under investigation in this study.
Lefamulin's in vitro antibacterial profile includes the most important bacterial pathogens
causing respiratory tract infection (RTI). The antibacterial spectrum comprises S.
pneumoniae, H. influenzae, M. catarrhalis, the atypical respiratory pathogens L. pneumophila,
C. pneumoniae, and M. pneumoniae, S. aureus including MRSA and CA-MRSA, ß-haemolytic
streptococci including S. pyogenes and S. agalactiae, and Enterococcus faecium including
vancomycin-resistant enterococci (VRE). Moreover, as demonstrated in cross-resistance
studies, lefamulin remains active against clinical isolates resistant to the following
antimicrobial(s) (classes): macrolides, lincosamides, streptogramin B, oxazolidinones,
tetracyclines, ß lactams, quinolones, trimethoprim-sulfametoxazole, mupirocin, and
vancomycin.

Inclusion Criteria:

Each subject must:

1. Be male or female at least 18 years of age.

2. Provide written informed consent and be willing and able to adhere to the
study-specified procedures and restrictions.

3. Have an acute illness (less than or equal to 7 days duration) with at least 3 of the
following symptoms consistent with a lower respiratory tract infection (new or
worsening):

- Dyspnea.

- New or increased cough.

- Purulent sputum production.

- Chest pain due to pneumonia.

4. Have at least 2 of the following vital sign abnormalities:

- Fever (body temperature > 38.0 °C (100.4 °F) measured orally or equivalent
temperature from an alternate body site) or hypothermia (body temperature < 35.0
°C (95.0 °F) measured orally or equivalent temperature from an alternate body
site).

- Hypotension (systolic blood pressure < 90 mmHg).

- Tachycardia (heart rate > 100 beats/min).

- Tachypnea (respiratory rate > 20 breaths/min).

5. Have at least 1 other clinical sign or laboratory finding of CABP:

- Hypoxemia (i.e., O2 saturation < 90 % on room air or while receiving supplemental
oxygen at subject's baseline requirement or PaO2 < 60 mmHg).

- Auscultatory and/or percussion findings consistent with pneumonia (e.g.,
crackles, egophony, dullness).

- White blood cell (WBC) count > 10 000 cells/mm3 or < 4 500 cells/mm3 or >15 %
immature neutrophils (bands) regardless of total WBC count.

6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e.,
infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray
or chest computed tomography scan consistent with acute bacterial pneumonia).

7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class of II, III, or IV and be an
appropriate candidate for oral antibiotic therapy as treatment for the current episode
of CABP.

Exclusion Criteria:

Each subject must NOT:

1. Have received more than a single dose of a short-acting oral or IV antibacterial for
CABP within 72 hours before randomization.

2. Require concomitant systemic antibacterial therapy potentially effective against CABP
pathogens.

3. Have been hospitalized for 2 or more days within 90 days prior to the onset of
symptoms or have resided in a nursing home or long-term healthcare facility within 30
days prior to the onset of symptoms. NOTE: Residence in an independent living facility
is permitted.

4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of
the study drugs (e.g., MRSA, Pseudomonas aeruginosa, any pathogen of the
Enterobacteriaceae Family) or attributable to etiologies other than community acquired
bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired
bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia
or other fungal pneumonia, viral or mycobacterial infection of the lung).

5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism,
chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart
failure, bronchial obstruction, lung cancer, cystic fibrosis).

6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic
effusions).