Bezisterim is under clinical development by BioVie and currently in Phase III for Alzheimer’s Disease. According to GlobalData, Phase III drugs for Alzheimer’s Disease have a 12% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Bezisterim’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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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.

Bezisterim overview

NE-3107 (Triolex, HE3286) is under development for the treatment of Alzheimer's disease, mid cognitive impairment, sleep and fatigue in subjects with traumatic brain injury, Parkinson's disease and Post-Acute Sequelae of COVID 2019 (PASC or Long COVID). The drug candidate is administered through oral route. The drug candidate is developed based on hormonal signaling technology platform. It acts by targeting ERK 1AND 2 (Extracellular Signal Regulated Kinase 1 and 2). The drug candidate was also under development for the treatment of inflammatory diseases, systemic lupus erythematosus, cystic fibrosis, type 2 diabetes, L-dopa induced dyskinesia, rheumatoid arthritis, ulcerative colitis and  multiple sclerosis.
It was under development for the treatment multiple myeloma, early stage prostate cancer, castration resistant prostate cancer.

BioVie overview

BioVie (BIVI) is a clinical-stage biopharmaceutical company that develops drug therapies for neurodegenerative and liver disease. The company’s pipeline products such as BIV201 (continuous infusion terlipressin), NE3107, and clinical trials for ascites due to advanced liver cirrhosis. BIV201 for hepatorenal syndrome (HRS). It focused on potential future treatment options for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by hepatitis, NASH, and alcoholism. NE3107 finds application in the treatment of excess cortisol diseases such as Alzheimer鈥檚 and Parkinson鈥檚 diseases. The company is also focused on the FDA to approve their drug specifically for treating ascites to extend their quality. BioVie is targeting this landmark achievement. BIVI is headquartered in Carson City, Nevada, the US.

For a complete picture of Bezisterim’s drug-specific PTSR and LoA scores,

This content was updated on 16 July 2024

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GlobalData鈥檚 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鈥檚 .