Savara Inc (SVRA)
Savara Inc. is a biopharmaceutical firm in the clinical development phase, specializing in therapies for uncommon respiratory conditions. Their primary investigational drug, molgramostim, is an inhaled form of granulocyte-macrophage colony-stimulating factor (GM-CSF). This compound is currently undergoing Phase III trials to address autoimmune pulmonary alveolar proteinosis. The company's main operations are situated in Austin, Texas.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Savara Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
poloxamer 188
Sickle Cell Anemia
NCT00004408Enrollment300StartNov 1997Primary Completion-CompletionNov 1999 - Phase 3Unknown status
Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
5- Fluorouracil (5-FU), bevacizumab (Avastin)
Metastatic Colorectal Cancer, Colon Cancer +1
NCT00337389Enrollment1,200StartMay 2006Primary Completion-Completion- - Phase 3Completed
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)
Saline, MST-188
Vaso-occlusive Crisis, Sickle Cell Disease
NCT01737814Enrollment388StartMay 2013Primary CompletionFeb 2016Completion- - Phase 3Completed
Evaluation of Repeat Administration of Purified Poloxamer 188
MST-188
Sickle Cell Disease
NCT02449616Enrollment16StartJun 2015Primary CompletionSep 2016Completion- - Phase 3Completed
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
Vancomycin inhalation powder, Placebo inhalation powder
MRSA, Cystic Fibrosis
NCT03181932Enrollment188StartSep 2017Primary CompletionJul 2020CompletionJan 2021 - Phase 3Terminated
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
Molgramostim
Autoimmune Pulmonary Alveolar Proteinosis
NCT03482752Enrollment60StartApr 2018Primary CompletionJan 2021CompletionJan 2021 - Phase 3Active, not recruiting
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Molgramostim, Placebo
Autoimmune Pulmonary Alveolar Proteinosis
NCT04544293Enrollment164StartMay 2021Primary CompletionNov 2023CompletionMay 2027est. - Phase 3Recruiting
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
Molgramostim
Autoimmune Pulmonary Alveolar Proteinosis
NCT06431776Enrollment5StartOct 2025Primary CompletionJun 2027est.CompletionDec 2027est. - Phase 2Completed
Clinical Trial in Patients With Metastatic Colorectal Cancer
CoFactor and 5FU
Colon Cancer, Rectal Cancer
NCT00081627Enrollment48StartApr 2004Primary Completion-CompletionJan 2007 - Phase 2Completed
Clinical Trial in Patients With Metastatic Colorectal Cancer
CoFactor, 5-FU
Colon Cancer, Rectal Cancer
NCT00235898Enrollment300StartMay 2005Primary CompletionMar 2008Completion- - Phase 2Unknown status
5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Treating Advanced Breast Cancer Patients
CoFactor (ANX-510)
Breast Cancer
NCT00434369Enrollment31StartFeb 2006Primary Completion-Completion- - Phase 2Completed
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
Vancomycin hydrochloride inhalation powder, Placebo inhalation powder
Cystic Fibrosis
NCT01746095Enrollment87StartMar 2013Primary CompletionNov 2014CompletionNov 2014 - Phase 2Terminated
Evaluation of MST-188 in Acute Lower Limb Ischemia
MST-188, Saline
Acute Limb Ischemia
NCT02093468Enrollment4StartJun 2014Primary CompletionDec 2016est.Completion- - Phase 2Terminated
Evaluation of Vepoloxamer in Chronic Heart Failure
Vepoloxamer
Chronic Heart Failure
NCT02596477Enrollment10StartOct 2015Primary CompletionOct 2016Completion- - Phase 2Completed
Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis
Molgramostim, Placebo
Autoimmune Pulmonary Alveolar Proteinosis
NCT02702180Enrollment139StartMar 2016Primary CompletionApr 2019CompletionSep 2019 - Phase 2Completed
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
Inhaled molgramostim, Antimycobacterial regimen
Mycobacterium Infections, Nontuberculous
NCT03421743Enrollment32StartMar 2018Primary CompletionOct 2019CompletionJan 2020 - Phase 2Terminated
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
Molgramostim nebulizer solution
Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF)
NCT03597347Enrollment14StartJun 2019Primary CompletionOct 2020CompletionOct 2020 - Phase 1Completed
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.
Vinorelbine Tartrate
Breast Cancer, Non-small Cell Lung Cancer +1
NCT00432562Enrollment31StartFeb 2007Primary CompletionNov 2007CompletionDec 2007 - Phase 1Completed
A Clinical Trial of CoFactor Formulations and Leucovorin Administered Intravenously in Healthy, Adult Subjects.
CoFactor, Leucovorin
Healthy Adults
NCT00663481Enrollment15StartApr 2008Primary CompletionMay 2008CompletionMay 2008 - Phase 1Completed
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
ANX-514, docetaxel
Advanced Cancer
NCT00664170Enrollment39StartApr 2008Primary CompletionApr 2009CompletionApr 2009 - Phase 1Completed
Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics
AeroVanc, IV vancomycin hydrochloride
Healthy, Cystic Fibrosis
NCT01537666Enrollment25StartNov 2011Primary CompletionMar 2012CompletionMar 2012 - Phase 1Completed
ANX-188 Thorough QT/QTc Study in Healthy Volunteers
ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose
Healthy
NCT01790087Enrollment72StartFeb 2013Primary CompletionApr 2013CompletionJun 2013 - Phase 1Completed
Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects
Molgramostim, Placebo
Pulmonary Alveolar Proteinosis, Bronchiectasis +2
NCT02468908Enrollment42StartMay 2015Primary CompletionOct 2015CompletionOct 2015 - Phase 1Completed
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
Vepoloxamer
Pharmacokinetics of Vepoloxamer, Healthy Volunteers +1
NCT02646358Enrollment27StartJan 2016Primary CompletionNov 2016Completion- - Expanded accessAvailable
Molgramostim Nebulizer Solution Expanded Access Program Protocol
Molgramostim nebulizer solution
Autoimmune Pulmonary Alveolar Proteinosis
NCT06546098Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | poloxamer 188 | NCT00004408 |
| Phase 3 | Unknown status | 5- Fluorouracil (5-FU), bevacizumab (Avastin) | NCT00337389 |
| Phase 3 | Completed | Saline, MST-188 | NCT01737814 |
| Phase 3 | Completed | MST-188 | NCT02449616 |
| Phase 3 | Completed | Vancomycin inhalation powder, Placebo inhalation powder | NCT03181932 |
| Phase 3 | Terminated | Molgramostim | NCT03482752 |
| Phase 3 | Active, not recruiting | Molgramostim, Placebo | NCT04544293 |
| Phase 3 | Recruiting | Molgramostim | NCT06431776 |
| Phase 2 | Completed | CoFactor and 5FU | NCT00081627 |
| Phase 2 | Completed | CoFactor, 5-FU | NCT00235898 |
| Phase 2 | Unknown status | CoFactor (ANX-510) | NCT00434369 |
| Phase 2 | Completed | Vancomycin hydrochloride inhalation powder, Placebo inhalation powder | NCT01746095 |
| Phase 2 | Terminated | MST-188, Saline | NCT02093468 |
| Phase 2 | Terminated | Vepoloxamer | NCT02596477 |
| Phase 2 | Completed | Molgramostim, Placebo | NCT02702180 |
| Phase 2 | Completed | Inhaled molgramostim, Antimycobacterial regimen | NCT03421743 |
| Phase 2 | Terminated | Molgramostim nebulizer solution | NCT03597347 |
| Phase 1 | Completed | Vinorelbine Tartrate | NCT00432562 |
| Phase 1 | Completed | CoFactor, Leucovorin | NCT00663481 |
| Phase 1 | Completed | ANX-514, docetaxel | NCT00664170 |
| Phase 1 | Completed | AeroVanc, IV vancomycin hydrochloride | NCT01537666 |
| Phase 1 | Completed | ANX-188 Therapeutic Dose, ANX-188 Supratherapeutic dose | NCT01790087 |
| Phase 1 | Completed | Molgramostim, Placebo | NCT02468908 |
| Phase 1 | Completed | Vepoloxamer | NCT02646358 |
| Expanded access | Available | Molgramostim nebulizer solution | NCT06546098 |