Brincidofovir by SymBio Pharmaceuticals for Adenoviridae Infections: Likelihood of Approval

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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.

Brincidofovir overview

Brincidofovir (Tembexa) is an alkoxyalkyl ester prodrug containing the synthetic, acyclic nucleoside monophosphate analog cidofovir, with antiviral activity. It is formulated as film coated tablets and suspension for oral route of administration. Tembexa is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates.

Brincidofovir (BCV, CMX-001) is under development for the prevention and treatment of smallpox, brain tumors, adenovirus (AdV) infections, BK virus infection after renal transplantation, Epstein-Barr virus (EBV) positive lymphoma, NK/T-cell lymphoma, cytomegalovirus-infected GBM, EB virus-associated multiple sclerosis and herpes simplex virus type 1 (HSV-1) infection Alzheimer’s dementia. The drug candidate is administered orally and intravenously. It is a prodrug of cidofovir. It is based on lipid-antiviral-conjugate technology. The drug candidate was also under development for diffuse large B-cell lymphoma, progressive multifocal leukoencephalopathy, monkeypox, human herpesvirus 6 (HHV-6), Ebola virus disease, adenovirus (AdV) infections, polyomavirus infections (BK virus) and other DNA virus-induced diseases.

SymBio Pharmaceuticals overview

SymBio Pharmaceuticals (SymBio) is a biopharmaceutical company that develops and markets anti-cancer drug candidates. The company’s pipeline product portfolio includes Treakisym (SyB L-0501), an anti-cancer agent used for the treatment of non-Hodgkin’s lymphoma (NHL), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL), rigosertib (SyB L-1101), a novel tumor-specific kinase inhibitor targeting hematologic malignancies and solid tumors and Brincidofovir (SyB V-1901) for effective treatment against a wide spectrum of infectious diseases caused by DNA viruses, including herpes viruses (including CMV), adenovirus, BK virus, papillomavirus and smallpox virus. It offers business and product development services in the areas of oncology, hematology and pain-management areas. SymBio is headquartered in Minato-ku, Tokyo, Japan.

For a complete picture of Brincidofovir’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.


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