brincidofovir IV (BCV IV) / SymBio Pharma, Jazz - LARVOL DELTA

A Phase 1b/2 Study of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=43 | Recruiting | Sponsor: SymBio Pharmaceuticals

New P1/2 trial • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Adenoviremia Clearance Following Treatment with Intravenous (IV) Brincidofovir (BCV) in Immunocompromised Patients is Associated with Positive Clinical Disease Response: Preliminary Outcomes from the ATHENA Phase IIa Study (IDWeek 2024) - No abstract available

Clinical • P2a data • Infectious Disease

ATHENA: A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (clinicaltrials.gov) - P2 | N=52 | Recruiting | Sponsor: SymBio Pharmaceuticals | N=24 ➔ 52

Enrollment change • Cytomegalovirus Infection • Infectious Disease

A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA) (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: SymBio Pharmaceuticals | Phase classification: P2a ➔ P2 | Trial completion date: Dec 2023 ➔ Sep 2026 | Trial primary completion date: Dec 2023 ➔ Sep 2026

Phase classification • Trial completion date • Trial primary completion date • Infectious Disease

Intravenous brincidofovir rapidly clears adenoviremia in immunocompromised patients: interim results from Phase 2a ATHENA study (ECCMID 2024) - No abstract available

Clinical • Late-breaking abstract • P2a data

PRELIMINARY RESULTS OF PHASE 2A CLINICAL TRIAL TO EVALUATE SAFETY, TOLERABILITY AND ANTIVIRAL ACTIVITY OF INTRAVENOUS BRINCIDOFOVIR IN IMMUNOCOMPROMISED PATIENTS WITH ADENOVIRUS INFECTION (EBMT 2024) - P2a | "Brincidofovir (BCV) is a lipid conjugate of cidofovir, that crosses cell membranes and has a long intracellular half-life. IV BCV was found to be safe and well tolerated in immunocompromised patients. Notably, the potentially serious gastrointestinal and hepatic toxicities described with the oral BCV formulation were not observed. IV BCV was highly effective in a dose-dependent manner, led to rapid clearance of AdV from blood and stool within a short treatment period and provided sustained virologic response."

Clinical • P2a data • Gastrointestinal Disorder • Hepatology • Infectious Disease • Pediatrics • Solid Organ Transplantation • Transplantation

Preliminary Results of a Phase 2a Clinical Trial to Evaluate Safety, Tolerability and Antiviral Activity of Intravenous Brincidofovir (BCV IV) in Immunocompromised Patients with Adenovirus Infection (TCT-ASTCT-CIBMTR 2024) - P2a | "Brincidofovir (BCV) is a lipid conjugate of cidofovir, that crosses cell membranes and has a long intracellular half-life. BCV IV was found to be safe and well tolerated in immunocompromised patients. Notably, the potentially serious gastrointestinal and hepatic toxicities described with the oral BCV formulation were not observed. BCV IV was highly effective in a dose-dependent manner, led to rapid clearance of AdV from blood and stool within a short treatment period and provided sustained virologic response."

Clinical • P2a data • Gastrointestinal Disorder • Hepatology • Infectious Disease • Pediatrics • Transplantation

Utility of Cytochrome P450 4F2 Genotyping to Assess Drug Interaction Risk for Brincidovovir, a Cytochrome P450 4F2 Substrate. (PubMed, Clin Pharmacol Drug Dev) - "Genotyping was performed on blood from healthy participants receiving oral (n = 261) and intravenous (IV, n = 49) brincidofovir across 6 phase 1 trials...Little to no increase in brincidofovir exposure parameters was observed following IV administration. Based on the lack of significant increases in brincidofovir plasma concentrations in subjects with low activity CYP4F2, a clinically meaningful drug-drug interaction is not expected with CYP4F2 inhibitor and brincidofovir coadministration."

Journal

Preliminary Results of a Phase 2a Clinical Trial to Evaluate Safety, Tolerability and Antiviral Activity of Intravenous Brincidofovir (BCV IV) in Immunocompromised Patients with Adenovirus Infection (ASH 2023) - P2a | "Brincidofovir (BCV) is a lipid conjugate of cidofovir, that crosses target cell membranes by means of facilitated and passive diffusion and has a long intracellular half-life. BCV IV was found to be safe and well tolerated in immunocompromised patients. Notably, the potentially serious gastrointestinal and hepatic toxicities described with the oral BCV formulation were not observed. BCV IV was highly effective in a dose-dependent manner, led to rapid clearance of AdV viremia within a short treatment period and provided sustained virologic response."

Clinical • P2a data • Gastrointestinal Disorder • Hepatology • Infectious Disease • Transplantation

A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA) (clinicaltrials.gov) - P2a | N=24 | Recruiting | Sponsor: SymBio Pharmaceuticals | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Infectious Disease

Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: SymBio Pharmaceuticals

New P2 trial • Glomerulonephritis • Infectious Disease • Renal Disease • Transplantation

A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA) (clinicaltrials.gov) - P2a | N=24 | Recruiting | Sponsor: SymBio Pharmaceuticals | Trial completion date: Aug 2022 ➔ Feb 2023 | Trial primary completion date: May 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Infectious Disease

A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (clinicaltrials.gov) - P2a; N=24; Recruiting; Sponsor: SymBio Pharmaceuticals; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Chimerix; Terminated ➔ Withdrawn

Clinical • Trial withdrawal • Bone Marrow Transplantation • Transplantation • PCR

Drug-Drug Interaction Study of Intravenous Administration of SyB V-1901 and Cyclosporine in Japanese Healthy Subjects (clinicaltrials.gov) - P1; N=13; Completed; Sponsor: SymBio Pharmaceuticals; Not yet recruiting ➔ Completed

Clinical • Trial completion

A Phase 2a Study of IV SyB V-1901 in Subjects With Adenovirus Infection (clinicaltrials.gov) - P2a; N=24; Not yet recruiting; Sponsor: SymBio Pharmaceuticals; Initiation date: Jan 2021 ➔ Jun 2021

Clinical • Trial initiation date • Infectious Disease

A Phase 2a Study of IV SyB V-1901 in Subject With Adenovirus Infection (clinicaltrials.gov) - P2a; N=24; Not yet recruiting; Sponsor: SymBio Pharmaceuticals

Clinical • New P2a trial • Infectious Disease

Chimerix to host annual investor update on April 27, 2017 (EIN News) - "Chimerix's Chief Medical Officer...will review newly available results from the single ascending dose study of IV brincidofovir, and plans to generate multiple-dose PK and safety data in healthy subjects as well as patient populations. These data are intended to inform the planned pivotal MVP-peds study for Multi-Viral Prevention of DNA viral infections."

PK/PD data • Cytomegalovirus Infection

Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia (clinicaltrials.gov) - P2; N=30; Not yet recruiting; Sponsor: Chimerix; Initiation date: May 2018 ➔ Aug 2018; Trial primary completion date: May 2019 ➔ Sep 2019

Trial initiation date • Trial primary completion date • Biosimilar

Oral Brincidofovir Decreased the Incidence of HHV-6B Viremia after Allogeneic HCT. (PubMed, Blood) - "In conclusion, brincidofovir prophylaxis reduced HHV-6B reactivation after allogeneic HCT in a post hoc analysis of a randomized controlled trial. These data support the study of intravenous brincidofovir for HHV-6B prophylaxis."

Journal

Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia (clinicaltrials.gov) - P2; N=1; Terminated; Sponsor: Chimerix; N=30 ➔ 1; Trial completion date: Dec 2019 ➔ May 2019; Recruiting ➔ Terminated; Trial primary completion date: Sep 2019 ➔ May 2019; terminated due to low enrollment rate

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination