Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

Key Inclusion Criteria:

- Current inpatient

- New onset of acute respiratory infectious symptoms, or acute worsening of chronic
symptoms related to ongoing respiratory disease for ≤ 5 days prior to screening:

- Upper respiratory tract symptoms: nasal congestion, runny nose, sore throat, or
earache

- Lower respiratory tract symptoms: cough, sputum production, wheezing, dyspnea, or
chest tightness

- Documented to be RSV-positive at the current admission within 72 hours of screening,
or as evaluated at screening

Key Exclusion Criteria:

- Related to concomitant or previous medication use:

- Use of oral prednisone or other corticosteroid equivalent to:

- > 20 mg/day for > 14 days prior to screening is not permitted.

- > 20 mg/day for ≤ 14 days, including corticosteroids received during current
hospitalization (ie, bolus doses), is permitted.

- ≤ 20 mg/day, regardless of duration, is permitted.

- Individuals taking a moderate or strong cytochrome P450 enzyme (CYP) inducer
including but not limited to rifampin, St John's Wort, carbamazepine, phenytoin,
efavirenz, bosentan, etracirine, modafinil, and nafcillin within 2 weeks prior to
the first dose of study drug

- Related to medical history:

- Pregnant, breastfeeding, or lactating females

- Individuals requiring > 50% supplemental oxygen (while the individual is awake)
at screening

- Individuals with a Clinical Frailty Scale (CFS) > 7 at Baseline

- Known significant abnormality altering the anatomy of the nose or nasopharynx
that in, the opinion of the investigator, will preclude obtaining adequate nasal
swab sampling in either nasal passage

- Waiting for or recently (within the past 12 months) received a bone marrow, stem
cell, or solid organ transplant, or who have received radiation or chemotherapy
within 12 months prior to Screening

- Individuals with HIV/AIDS and a known CD4 count < 200 cells/uL

- History of severe dementia or Alzheimer's disease

- History of drug and/or alcohol abuse that, in the opinion of the investigator,
may prevent adherence to study activities

- Related to medical condition at screening:

- Influenza-positive as determined by local diagnostic test

- Known Middle East Respiratory Syndrome coronavirus (MERS-CoV) infection or known
coinfection with other coronavirus

- Use of mechanical ventilation during the current admission, not including
noninvasive ventilation

- Clinically significant bacteremia or fungemia that has not been adequately
treated prior to Screening, as determined by the investigator

- Inadequate treatment of confirmed bacterial, fungal, or non-RSV pneumonia, as
determined by the investigator

- Excessive nausea/vomiting at admission, as determined by the investigator, that
precludes administration of an orally administered study drug

- Related to allergies:

- Known allergy to components of the study drug (microcrystalline cellulose,
mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium
dioxide, polyethylene glycol and talc)

- Documented history of acute (anaphylaxis) or delayed (Stevens-Johnson syndrome or
epidermal necrolysis) allergy to sulfa drugs

Note: Other protocol defined Inclusion/Exclusion criteria may apply.