You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR BRINCIDOFOVIR


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Brincidofovir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00793598 ↗ CMX001 in Post-transplant Patients With BK Virus Viruria Completed Chimerix Phase 1/Phase 2 2009-11-01 This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria.
NCT00942305 ↗ Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients Completed Chimerix Phase 2 2009-10-01 This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks. Dosing was initiated immediately following engraftment (between Days 14-30 post-transplant) to prevent/control cytomegalovirus (CMV) infection or prevent disease in R+ hematopoietic stem cell transplant (HCT) recipients.
NCT01143181 ↗ Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses Completed Chimerix Phase 3 2010-12-01 This was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious disease or conditions caused by double-stranded DNA (dsDNA) virus(es). Subjects received either a weight-based or a fixed dose of oral BCV once weekly (QW) or twice weekly (BIW) for up to 3 months until clinical disease was resolved or stabilized and/or viral DNA by polymerase chain reaction testing was negative for 4 consecutive weeks, whichever was longer. Under the first protocol amendment, adults and adolescents (≥13 years) received 200 mg or 300 mg BCV BIW (not to exceed 4 mg/kg total weekly dose) depending on the difficulty of treating their disease (i.e., Group 1 or Group 2, respectively), and pediatric subjects (≤12 years) received 4 mg/kg BCV BIW. Under the second protocol amendment, adults and adolescents (≥13 years), regardless of viral infection/disease, had a maximum weekly dose of 200 mg, i.e., 200 mg QW or 100 mg BIW; not to exceed 4mg/kg total weekly dose. Pediatric subjects (≤12 years), regardless of viral infection/disease, had a maximum weekly dose of 4 mg/kg, i.e., 4 mg/kg QW or 2 mg/kg BIW; not to exceed 200 mg.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Brincidofovir

Condition Name

Condition Name for Brincidofovir
Intervention Trials
Adenovirus 4
Adenovirus Infection 2
Cytomegalovirus Disease 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Brincidofovir
Intervention Trials
Adenoviridae Infections 7
Infections 5
Communicable Diseases 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Brincidofovir

Trials by Country

Trials by Country for Brincidofovir
Location Trials
United States 206
United Kingdom 5
Canada 4
Spain 3
Belgium 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Brincidofovir
Location Trials
California 14
North Carolina 11
Illinois 10
Ohio 10
Washington 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Brincidofovir

Clinical Trial Phase

Clinical Trial Phase for Brincidofovir
Clinical Trial Phase Trials
Phase 3 5
Phase 2 8
Phase 1/Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Brincidofovir
Clinical Trial Phase Trials
Completed 9
Terminated 5
Withdrawn 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Brincidofovir

Sponsor Name

Sponsor Name for Brincidofovir
Sponsor Trials
Chimerix 16
SymBio Pharmaceuticals 3
Food and Drug Administration (FDA) 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Brincidofovir
Sponsor Trials
Industry 20
U.S. Fed 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Brincidofovir: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Brincidofovir, a broad-spectrum antiviral drug, has been making significant strides in the medical field, particularly in the treatment of viral infections in immunocompromised patients. Developed by Chimerix and now under the exclusive global licensing rights of SymBio Pharmaceuticals for most indications, brincidofovir is poised to address several critical medical needs.

Clinical Trials Update

Adenovirus Infections

A recent Phase 2a study presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition has shown promising results for brincidofovir in treating adenovirus infections in immunocompromised patients. The study demonstrated:

  • 100% adenovirus viremia clearance from plasma in patients treated with intravenous brincidofovir at 0.4 mg/kg twice weekly.
  • Viral clearance within 4 weeks in 90% of the patients.
  • No serious treatment-related adverse events were observed, and all adverse events were reversible and resolved after treatment completion[1].

Cytomegalovirus (CMV) Infections

SymBio has initiated a Phase 2 clinical trial targeting CMV infections after hematopoietic stem cell transplantation, with the first patients enrolled in June 2024. This trial is part of the broader development pipeline aimed at expanding the indications for brincidofovir[2].

Other Ongoing and Planned Trials

  • Mpox Virus Treatment: A new clinical trial, sponsored by PANTHER under the leadership of the Africa Centres for Disease Control and Prevention, will evaluate the safety and efficacy of brincidofovir in treating mpox virus in a randomized double-blind placebo-controlled trial[4].
  • Anti-Tumor Effects: Collaborative studies with institutions like the National Cancer Centre Singapore and the University of California, San Francisco, are ongoing to confirm the anti-cancer activity of brincidofovir and its synergistic effects when combined with its antiviral activity[1].
  • Neurodegenerative Diseases: SymBio is also exploring the use of brincidofovir in treating neurodegenerative diseases caused by viral infections, such as multiple sclerosis and Alzheimer's dementia[2].

Mechanism of Action and Special Characteristics

Brincidofovir is a lipid conjugate of cidofovir (CDV), which enhances its cellular uptake and antiviral activity. Key features include:

  • Broad-Spectrum Activity: Brincidofovir has shown in vitro potency against a wide range of double-stranded DNA viruses, including adenoviruses, cytomegalovirus, Epstein-Barr virus, herpes viruses, and others[1][3].
  • Low Nephrotoxicity: Unlike other antiviral agents like cidofovir and foscarnet, brincidofovir has low nephrotoxicity, making it a safer option for patients[2].

Market Analysis and Projections

Current Market Landscape

The market for brincidofovir is expected to be significant, particularly in the areas of:

  • Disseminated Adenovirus Infections: Estimated market size for resistant/refractory adenovirus infections after hematopoietic stem cell transplantation is substantial[2].
  • Cytomegalovirus Infections: The market for first-line CMV infections after HSC transplantation is estimated at around JPY126 billion, with additional potential in the JPY42 billion market for resistant/refractory CMV infections[2].

Projected Market Size

SymBio anticipates a total market of JPY252 billion for brincidofovir, targeting various disease areas including:

  • Infections Post-Transplantation: Adenovirus, CMV, and BK virus infections.
  • Cancers Caused by Viral Infections: NK/T-cell lymphoma, glioblastoma, etc.
  • Neurodegenerative Diseases: Multiple sclerosis, Alzheimer's dementia, etc.[2].

Global Partnership and Commercialization

SymBio is actively pursuing global partnerships to expedite the commercialization of brincidofovir. The company has already acquired exclusive global licensing rights from Chimerix (later transferred to Emergent BioSolutions Inc., but not affecting SymBio's rights) and is now positioned to license out developed products globally[2].

Key Takeaways

  • Clinical Success: Brincidofovir has shown promising results in clinical trials for adenovirus and is being explored for CMV and other viral infections.
  • Broad-Spectrum Activity: The drug's mechanism of action and low nephrotoxicity make it a valuable asset in treating a wide range of viral infections.
  • Market Potential: The estimated market size for brincidofovir is substantial, with significant potential in various disease areas.
  • Global Expansion: SymBio is working towards early commercialization and global partnerships to maximize the drug's reach.

FAQs

What is brincidofovir and how does it work?

Brincidofovir is a broad-spectrum antiviral drug that is a lipid conjugate of cidofovir. It enhances cellular uptake and antiviral activity, showing potency against a wide range of double-stranded DNA viruses.

What are the current clinical trials for brincidofovir?

Current trials include Phase 2a studies for adenovirus infections, Phase 2 trials for CMV infections, and upcoming trials for mpox virus treatment and anti-tumor effects.

What are the special characteristics of brincidofovir compared to other antiviral drugs?

Brincidofovir has low nephrotoxicity and superior antiviral activity compared to other drugs like cidofovir and foscarnet.

What is the estimated market size for brincidofovir?

The estimated market size for brincidofovir is around JPY252 billion, targeting various disease areas including infections post-transplantation, cancers caused by viral infections, and neurodegenerative diseases.

Who is involved in the development and commercialization of brincidofovir?

SymBio Pharmaceuticals Limited holds the exclusive global licensing rights for brincidofovir and is working with various institutions and partners for its development and commercialization.

What are the potential future indications for brincidofovir?

Future indications include treating neurodegenerative diseases like multiple sclerosis and Alzheimer's dementia, as well as cancers caused by viral infections such as NK/T-cell lymphoma and glioblastoma.

Sources

  1. SymBio Pharmaceuticals Limited, "SymBio Announces Positive Preliminary Data from Ongoing Phase 2a Study of Intravenous Brincidofovir in Immunocompromised Patients With Adenovirus Infection," November 2023.
  2. SymBio Pharmaceuticals Ltd., "BCV: Heading for a global partnership," AnalystNet Report, September 30, 2024.
  3. Chimerix, "Chimerix Announces Positive Topline Results From Brincidofovir Pivotal Study in Animal Model for Smallpox," Press Release.
  4. Emergent BioSolutions Inc., "Emergent BioSolutions Supports New Clinical Trial Evaluating the Safety and Efficacy of Brincidofovir in Treating Mpox Virus Across Africa," GlobeNewswire, November 6, 2024.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.