Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary
parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or
dyspnea. The widespread emergence of antibiotic resistant pathogens, including the
macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective
antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation
macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key
typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed
comparable efficacy to levofloxacin in adults with CABP.

Inclusion Criteria:

- Male and female patients ≥ 18 years of age

- An acute onset of at least 3 of the following signs and symptoms (new or worsening):

1. Cough

2. Production of purulent sputum

3. Shortness of breath (dyspnea)

4. Chest pain due to pneumonia

- At least 1 of the following:

1. Fever

2. Hypothermia

3. Presence of pulmonary rales and/or evidence of pulmonary consolidation

- PORT Risk Class II, III, or IV

- Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with
acute bacterial pneumonia on a pulmonary imaging study

- Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

- Ventilator-associated pneumonia

- Known anatomical or pathological bronchial obstruction or a history of bronchiectasis
or documented severe chronic obstructive pulmonary disease

- Hospitalization within 90 days or residence in a long-term care facility within 30
days prior to the onset of symptoms

- Presence of known:

1. Viral or fungal pneumonia

2. Pneumocystis jiroveci pneumonia

3. Aspiration pneumonia

4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism,
hypersensitivity pneumonia, congestive heart failure)

5. Primary or metastatic lung cancer

6. Cystic fibrosis

7. Active or suspected tuberculosis

- Known HIV or myasthesia gravis