Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection

Key Inclusion Criteria:

- Males and females ≥18 years of age who have received a LT (single or double) or
heart/lung transplant > 90 days prior to Screening

- Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing
(starting from when the upper or lower respiratory tract sample is obtained) ≤ 7 days
prior to investigational medicinal product (IMP) administration on Day 1/Baseline

- New onset or acute worsening, if the symptom is chronic, of at least 1 of the
following respiratory symptoms ≤ 7 days prior to IMP administration on Day 1/Baseline:
nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or
wheezing

- A negative local urine or serum pregnancy test for female subjects of childbearing
potential at Screening, within 1 day prior to IMP administration. When available,
existing local pregnancy test results obtained prior to Screening may be used,
provided the testing was completed within 1 day prior to IMP administration

- Agreement from male and female subjects of childbearing potential who engage in
heterosexual intercourse to use protocol specified method(s) of contraception

Key Exclusion Criteria:

Related to concomitant or previous medication use:

- Use of any non-marketed (according to region) investigational agents within 30 days,
OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5
half-lives of Screening, whichever is longer, OR use of any prior investigational RSV
vaccines

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

Related to transplant history:

• Recipient of any other organ transplant prior to Screening, with the exception of a LT
(single or double) or heart/lung transplant

Related to medical condition at Screening:

- Known viral coinfection (including but not limited to influenza, metapneumovirus,
human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or
lower respiratory tract ≤ 14 days prior to Screening unless discussed with the medical
monitor and deemed acceptable

- Active systemic infection or infectious pneumonia of any etiology (ie, bacterial,
viral [other than RSV] or fungal), including aspiration pneumonia, that is considered
clinically significant by the investigator unless discussed with the medical monitor
and deemed acceptable

Related to laboratory values:

- Clinically significant kidney dysfunction as defined by: An estimated glomerular
filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated by the Modification of Diet
in Renal Disease (MDRD) study 4 parameter equation obtained from screening laboratory
measurements or via local laboratory measurements obtained ≤ 7 days prior to
Screening. The eGFR may be manually calculated or the reported eGFR value may be used,
but any automatically calculated eGFR must be calculated using the MDRD equation.

- Clinically significant liver function test abnormalities as defined by an alanine
aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit
of normal (ULN) obtained in screening laboratory measurements or via local laboratory
measurements obtained ≤ 7 days prior to Screening

- Clinically significant elevations in total bilirubin (TB), as determined by the
investigator

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