Molgramostim is under clinical development by Savara and currently in Phase III for Lung Disease. According to GlobalData, Phase III drugs for Lung Disease have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Molgramostim’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Molgramostim overview
Molgramostim (Molgradex) is under development for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), acute respiratory distress syndrome, coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and non-tuberculous Mycobacteria (NTM) lung infections. It is administered via inhalational route as a solution. Molgramostim is a recombinant human granulocyte macrophage colony stimulating factor (GM-CSF). The drug candidate acts by targeting granulocyte macrophage colony-stimulating factor (GM-CSF) receptor. The drug development is developed based on veltis technology. It was also under development for the treatment of cystic fibrosis-related lung infection (CF), bronchiectasis (BE) and ventilator-associated pneumonia (VAP).
Savara overview
Savara, formerly Mast Therapeutics Inc, is a clinical-stage biopharmaceutical company, which develops therapies for the treatment of rare respiratory diseases, including cystic fibrosis (CF), and pulmonary alveolar proteinosis (PAP). The company’s lead product candidates include Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of PAP; and AeroVanc, an inhaled formulation of vancomycin for the treatment of CF. The company has subsidiaries in the US, and Denmark. Savara is headquartered in Austin, Texas, the US.
For a complete picture of Molgramostim’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
