Clinical Studies (Previous and ongoing)
Savara is an orphan lung disease company and our pipeline is comprised of the following inhaled investigational therapies: Molgradex, Apulmiq, and AeroVanc.
MOLGRADEX (inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF) is being evaluated for the following indications:
- Autoimmune pulmonary alveolar proteinosis (aPAP)
- Nontuberculous mycobacteria (NTM) lung infection in people living with cystic fibrosis (CF) and NTM in people who are not affected by CF
APULMIQ (inhaled ciprofloxacin) will be evaluated for the treatment of non-cystic fibrosis bronchiectasis (NCFB).
AEROVANC (vancomycin hydrochloride inhalation powder) is being evaluated for the treatment of persistent methicillin-resistant Staphylococcus aureus, or MRSA, lung infection in CF.
Molgradex – aPAP
Molgradex is the first inhaled GM-CSF being developed for the treatment of a rare respiratory disease called autoimmune pulmonary alveolar proteinosis (aPAP). A pivotal Phase 3 clinical study, called IMPALA, was completed in 2019. The press release announcing results from the 24-week, double-blind period of the study can be found here. The press release announcing results from the open-label period can be found here. A second Phase 3 study is being planned.
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Molgradex – NTM
Molgradex was evaluated in a Phase 2a clinical study, called OPTIMA, for the treatment of patients with nontuberculous mycobacterial (NTM) lung infection, a rare and serious lung disorder associated with increased rates of morbidity and mortality. The press release announcing topline results of the study can be found here. The next steps for this program will be determined once results from the ENCORE study (which is evaluating Molgradex for the treatment of NTM in people living with CF) are available.
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Molgradex – NTM in CF
Molgradex is being evaluated in a Phase 2a clinical study, called ENCORE, for the treatment of nontuberculous mycobacterial (NTM) lung infection in people living with CF. NTM is a rare and serious lung disorder associated with increased rates of morbidity and mortality.
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AeroVanc – MRSA in CF
AeroVanc is the first inhaled antibiotic being developed to address the growing problem of chronic methicillin-resistant Staphylococcus aureus (MRSA) lung infection in people with CF. A pivotal Phase 3 clinical study, called AVAIL, is ongoing.
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Summary of Savara’s U.S. Expanded Access Policy
Savara Nasdaq Opening Bell Ceremony - July 23, 2018
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