Opaganib is under clinical development by RedHill Biopharma and currently in Phase III for Coronavirus Disease 2019 (COVID-19) Pneumonia. According to GlobalData, Phase III drugs for Coronavirus Disease 2019 (COVID-19) Pneumonia have an 8% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Opaganib’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.

Opaganib overview

Opaganib (ABC-294640) is under development for the treatment of neuroblastoma, renal interstitial fibrosis, advanced, unresectable intra-hepatic, gastrointestinal acute radiation syndrome (GI-ARS), mustard gas (sulfur mustard) poisoning, perihilar and extra-hepatic cholangiocarcinoma, non-small cell lung cancer, advanced solid tumors, pancreatic cancer, bile duct cancer (cholangiocarcinoma), colorectal cancer, metastatic castration resistant prostate cancer, Pseudomonas aeruginosa-induced lung injury, radiation-induced lung inflammation and fibrosis, acute kidney injury, pneumonia, coronavirus disease (COVID-19) and Ebola virus infection, chikungunya virus, respiratory syncytial virus (RSV) infection, type 2 diabetes and obesity, inflammatory bowel disease (IBD) including ulcerative colitis and Crohn's disease. It is administered orally as a capsule. It is an aryladamantane derivative. The drug candidate acts by targeting sphingosine kinase-2 (SK2), dihydroceramide desaturase and glucosylceramide synthase. The drug candidate is a new chemical entity.
The drug candidate was also under development for multiple myeloma, hepatocellular carcinoma, diffuse large B-cell lymphoma, Kaposi sarcoma and retinopathy, primary effusion lymphoma, liver transplantation, ulcerative colitis and rheumatoid arthritis. It was also under development as a radioprotectant for the prevention of mucositis and head and neck cancer.

RedHill Biopharma overview

RedHill Biopharma (RedHill) is a specialty biopharmaceutical company. It advances treatment options for gastrointestinal (GI) and infectious diseases with key products like Talicia, an oral capsule for Helicobacter pylori, and Aemcolo, for travelers’ diarrhea. The company’s pipeline includes opaganib, a first-in-class new chemical entity with multiple therapeutic potentials, including treatment for gastrointestinal acute radiation syndrome (GI-ARS), COVID-19, various viral infections, inflammatory conditions, solid tumors, cholangiocarcinoma and metastatic castration-resistant prostate cancer. It is developing RHB-107, a novel serine protease inhibitor for early COVID-19 outpatient treatment; RHB-102, a bimodal release formulation of ondansetron that has shown efficacy in chemotherapy-induced nausea and IBS-D; RHB-204, which targets pulmonary nontuberculous mycobacteria; and RHB-104, an antibiotic therapy that has demonstrated positive results in Crohn’s disease and multiple sclerosis. RedHill is headquartered in Tel Aviv, Israel.

For a complete picture of Opaganib’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.