Ulixertinib is under clinical development by BioMed Valley Discoveries and currently in Phase I for Neurofibromatoses Type I (Von Recklinghausen’s Disease). According to GlobalData, Phase I drugs for Neurofibromatoses Type I (Von Recklinghausen’s Disease) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Ulixertinib’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.
Ulixertinib overview
Ulixertinib (BVD-523) is under development for the treatment of metastatic uveal melanoma, metastatic melanoma, non-small cell lung cancer, acute myelogenous leukemia, colorectal cancer, metastatic pancreatic cancer, histiocytic neoplasms, myelodysplastic syndromes, esophageal squamous cell carcinoma, adenocarcinoma of the gastroesophageal junction, gastric cancer, pancreatic cancer, extrahepatic bile duct cancer, low grade glioma, oligodendroglioma, neurofibromatosis type 1, bile duct cancer and histiocytosis (hematological tumor). The drug candidate is a small molecule and is administered orally. It acts by targeting ERK1 and 2 (Extracellular signal-Regulated Kinases).
It was also under development for metastatic adenocarcinoma of the pancreas, metastatic colorectal cancer.
BioMed Valley Discoveries overview
BioMed Valley Discoveries (BVD), a subsidiary of Stowers Institute For Medical Research, is a clinical-stage biotechnology company that operates in pursuit of groundbreaking medicines. The company’s product is ulixertinib (BVD-523), a highly selective, first-in-class inhibitor of ERK, a key component of the mitogen-activated protein kinases (MAPK) pathway. BVD also advances other oncology programs, including TEM8 and CNV-NT. The company’s products are designed to address the needs of patients with MAPK pathway-driven cancers who currently have limited treatment options. Its products are used in various clinical studies and trials across the healthcare industry. The company collaborates with a range of partners for the development and distribution of its products. BVD is headquartered in Kansas City, Missouri, the US.
For a complete picture of Ulixertinib’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.
