A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia

Inclusion Criteria:

Participants must meet all of the following inclusion criteria in order to be eligible for
the study:

1. Is a hospitalized male or female, ≥ 18 years of age at the Screening Visit;

2. Has been admitted to the ICU and is on mechanical ventilation;

3. Has a known or suspected mechanically ventilated bacterial pneumonia with at least 1
of the following:

- Fever (> 38.5ﾟC or > 101.3ﾟF);

- Hypothermia (≤ 35.0ﾟC or ≤ 95.0ﾟF);

- Leukopenia (≤ 4500 cells/mm3);

- Leukocytosis (≤ 10000 cells/mm3);

- White blood cell count with left shift defined as > 15% immature
olymorphonuclear leukocytes (bands) on peripheral blood smear; or

- Procalcitonin > 0.25 µg/mL;

Plus at least 2 of the following:

- Respiratory failure requiring mechanical ventilation;

- New onset of expectorated or suctioned purulent sputum production or respiratory
secretions, or a change in the character of sputum;

- Auscultatory findings on pulmonary examination of rales and/or evidence of
pulmonary consolidation;

- Dyspnea, tachypnea, or signs of respiratory distress as evidenced by an increase
in respiratory support or oxygen requirement, particularly if any or all of
these are progressive in nature; or

- Hypoxemia by pulse oximetry or arterial blood gas requiring an increase in
supplemental oxygen;

4. Has a chest X-ray with a new consolidation consistent with pneumonia or significant
worsening of previous findings consistent with pneumonia;

5. Has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and ≤
30 at the Screening Visit;

6. Is expected by the Investigator to require mechanical ventilation and intubation for
at least 3 days.

Exclusion Criteria:

Participants who meet any of the following exclusion criteria will not be enrolled in the
study:

1. Has a requirement of inhaled non-study antibiotic;

2. Has been treated with systemic antibacterial therapy for the current mechanically
ventilated bacterial pneumonia episode for > 48 hours within 72 hours of study entry
with either of the following exceptions:

1. Unequivocal clinical evidence of treatment failure of the current mechanically
ventilated bacterial pneumonia episode (eg, worsening signs and symptoms)
following ≥ 48 hours of prior systemic antimicrobial therapy; or

2. Documented isolation of an identified pathogen from blood or respiratory culture
from the current mechanically ventilated bacterial pneumonia episode that is
resistant to the prior systemic antimicrobial therapy;

3. Has been treated with any inhaled antibiotic (including inhaled aminoglycosides)
within 72 hours of study entry;

4. Has renal insufficiency at Screening as evidenced by an estimated creatinine
clearance <50 mL/min based on the Cockcroft-Gault formula;

5. Is at risk of rapidly fatal illness and death within the next 72 hours;

6. Is a pregnant or nursing female. Females of childbearing potential must have a serum
pregnancy test prior to enrollment. If results of the serum pregnancy test are not
available prior to the Day 1 Treatment Visit, the patients may be enrolled on the
basis of a negative urine pregnancy test; however, the results of the serum pregnancy
test must still be obtained. If either test is positive, the patients must be
excluded;

7. Has myasthenia gravis, parkinsonism, or any other progressive neuromuscular disorder;

8. Has a history of epilepsy or known seizure disorder;

9. Has a history of sensorineural hearing loss resulting from any therapy known as
ototoxic (eg, aminoglycosides, cisplatin, loop diuretics, or quinine);

10. Has received any investigational medication in the last 30 days (or 5 half-lives of
the investigational medication, whichever is longer) prior to the Screening Visit;

11. Has known hypersensitivity to ME1100, aminoglycosides, or any of the specifiedBest
Available Therapy agents or their excipients.