Pegargiminase is under clinical development by Polaris Pharmaceuticals and currently in Phase II for Metabolic Dysfunction-Associated Steatohepatitis (MASH). According to GlobalData, Phase II drugs for Metabolic Dysfunction-Associated Steatohepatitis (MASH) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pegargiminase’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Pegargiminase overview

Pegargiminase (ADI-PEG 20) is under development for the treatment of newly diagnosed recurrent glioblastoma multiforme, gliosarcome, glioblastoma multiforme, hepatocellular carcinoma (third line therapy), melanoma, mesothelioma, advanced gastrointestinal malignancies, small-cell lung cancer, soft tissue sarcomas, sarcomatoid cancers, glioma and leiomyosarcoma. It is administered as an intramuscular injection. ADI is a microbial enzyme that degrades arginine. It is also called pegylated arginine deiminase. It is developed by using the company's proprietary pegylation technology. It was also under development for the treatment of refractory acute myeloid leukemia, relapsed acute myeloid leukemia, pancreatic cancer, colorectal cancer, gastric cancer, hepatocellular carcinoma (HCC), hepatitis C, pediatric cancer including sarcoma, lymphoma and leukemia, ovarian cancer, HER2 negative metastatic breast cancer, peritoneal cancer,  metastatic uveal melanoma, head and neck squamous cell carcinoma, thymus cancer and nasopharyngeal carcinoma, non-Hodgkin lymphoma, bladder cancer, non-alcoholic steatohepatitis (NASH) and osteosarcoma, Ewing Sarcoma, non-squamous non-small cell lung cancer and metastatic castration resistant prostate cancer.

Polaris Pharmaceuticals overview

Polaris Pharmaceuticals (PPI), a subsidiary of Polaris Group, is a biotechnology research and development company that develops new technologies and processes which streamline drug development. The company carries out expression system development, analytical chemistry, and purification system development process. It offers process development, production expertise, and manufacturing services. PPI provides inputs to avoid early process pitfalls and advances compounds to the clinic. The company operates with a manufacturing facility in the US. PPI is headquartered in San Diego, California, the US.

For a complete picture of Pegargiminase’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.