Chimerix Announces Preliminary Data from Ongoing Phase 1 Dose Escalation Study of Intravenous Brincidofovir in Healthy Subjects
January 06, 2017 at 06:30 pm IST
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Chimerix announced preliminary data from an ongoing Phase 1 study to investigate the safety, tolerability and plasma/intracellular concentration of intravenous (IV) brincidofovir (BCV) following single escalating doses in healthy adult subjects. In this ongoing study, IV administration of BCV demonstrated a favorable tolerability profile at both doses tested to date. No drug related adverse events (AEs) or laboratory abnormalities were identified. Notably, gastrointestinal (GI) side effects were absent. Blood plasma concentrations of BCV which have previously demonstrated anti-viral potency in cytomegalovirus (CMV) prevention and adenovirus treatment were achieved with IV doses that were one tenth of those required with oral dosing. This suggests that even the lowest tested IV dose of brincidofovir should provide antiviral activity. A total of 40 healthy subjects will be randomized to receive either a single dose of IV BCV or IV placebo in one of four cohorts. To date, 16 subjects have enrolled into 2 dose groups; 8 subjects were randomized in each of Cohorts 1 (IV BCV 10 mg) and 2 (IV BCV 25 mg). It is anticipated that two additional cohorts will be enrolled. As the new IV formulation of BCV progresses in clinical studies, BCV remains in development as an orally-administered lipid conjugate nucleotide for the treatment of adenovirus in hematopoietic cell transplant recipients and other immunocompromised patients, and as a medical countermeasure for the treatment of smallpox.
Chimerix, Inc. is a biotechnology company. The Company is focused on developing medicines that address unmet medical needs. The Company's product Imipridones is a cancer therapy that provides ONC201, which is in clinical-stage development for H3 K27M-mutant glioma as its lead indication. In addition, imipridone ONC206 is in dose-escalating clinical trials. Imipridones target specific G protein-coupled receptors (GPCRs) and mitochondrial caseinolytic protease P (ClpP), resulting in cancer cell death. The Company's product Imipridone chemical scaffold provides an opportunity to target GPCRs and ClpP with differential specificity and function. Its ONC212 is an imipridone, an investigational agonist of the orphan GPCR tumor suppressor GPR132, as well as ClpP. Its CMX521 is a nucleoside analog antiviral drug candidate for the treatment of SARS-CoV-2. The Chimerix Chemical Library contains over 10,000 heterocyclic ring systems and nucleosides, also includes approximately 3,500 nucleosides.