Garadacimab is under clinical development by CSL and currently in Phase II for Idiopathic Pulmonary Fibrosis. According to GlobalData, Phase II drugs for Idiopathic Pulmonary Fibrosis have a 35% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Garadacimab’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.
Garadacimab overview
Garadacimab (CSL-312) is under development for the treatment of hereditary angioedema (HAE), idiopathic pulmonary fibrosis (IPF) and interstitial lung diseases (ILD). It is administered through subcutaneous and intravenous routes. The drug candidate is a recombinant fully human monoclonal antibody. It is a variant of 3F7 with improved affinity and potency. The drug candidate acts by targeting FXIIa.
The drug candidate was also under development for the treatment of contact-activated thrombosis, acute respiratory distress syndrome (ARDS), coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and pneumonia.
CSL overview
CSL is a biotechnology company. It discovers, develops, manufactures, commercializes and distributes biopharmaceuticals. The company’s product portfolio comprises treatments for hemophilia and immune deficiency, vaccines to prevent influenza and therapies for iron deficiency and kidney conditions. CSL‘s proprietary platform consists of plasma and recombinant protein technology, cell and gene therapy and adjuvant cell-based egg-based mRNA. CSL focuses on conditions related to hematology, respiratory, cardiovascular and metabolic, nephrology and transplant, immunology and vaccines, among others. The company operates in various countries including Australia, China, Germany, Switzerland, the US, Hungary, Puerto Rico, the UK, Italy, Japan, the Netherlands and Spain. CSL is headquartered in Melbourne, Victoria, Australia.
For a complete picture of Garadacimab’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.
