Theriva Biologics
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2001-01-01
- Employees
- 22
- Market Cap
- -
- Website
- http://www.therivabio.com
- Introduction
Theriva Biologics, Inc.(formerly Synthetic Biologics, Inc.) is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. Its product portfolio includes SYN-020 and SYN-004. SYN-020 is intended to prevent the antibiotic-mediated microbiome damage, C. difficile infections (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host disease (aGVHD) in allogeneic HCT recipients. SYN-004 is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance. The company was founded by Steven H. Kanzer in January 2001 and is headquartered in Rockville, MD.
Clinical Trials
8
Trial Phases
2 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (8 trials with phase data)• Click on a phase to view related trials
Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020
- Conditions
- Enteritis Caused by Radiation
- Interventions
- Drug: SYN-020 Delayed Release Capsule
- First Posted Date
- 2021-09-16
- Last Posted Date
- 2022-04-21
- Lead Sponsor
- Theriva Biologics, Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT05045833
- Locations
- 🇺🇸
Spaulding Clinical Research LLC, West Bend, Wisconsin, United States
Pharmacokinetics, Safety, and Tolerability of SYN-020
- Conditions
- Enteritis Caused by Radiation (Disorder)
- Interventions
- Drug: SYN-020 delayed release capsule
- First Posted Date
- 2021-03-25
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Theriva Biologics, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT04815993
- Locations
- 🇺🇸
Spaulding Clinical Research LLC, West Bend, Wisconsin, United States
SYN-004 Safety and Tolerability in Allo-HCT Subjects
- Conditions
- Acute Graft-Versus-Host Reaction Following Bone Marrow TransplantPrevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
- Interventions
- Biological: SYN-004, Ribaxamase or Placebo
- First Posted Date
- 2020-12-31
- Last Posted Date
- 2025-01-06
- Lead Sponsor
- Theriva Biologics, Inc.
- Target Recruit Count
- 36
- Registration Number
- NCT04692181
- Locations
- 🇺🇸
Washington University, Saint Louis, Missouri, United States
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
- Conditions
- Clostridium InfectionsClostridium Difficile
- Interventions
- Drug: Placebo
- First Posted Date
- 2015-09-29
- Last Posted Date
- 2018-11-27
- Lead Sponsor
- Theriva Biologics, Inc.
- Target Recruit Count
- 413
- Registration Number
- NCT02563106
- Locations
- 🇷🇸
Synthetic Biologics Investigational Site, Čačak, Serbia
🇷🇴Synthetic Biologics Investigational SIte, Bucharest, Romania
🇵🇱SyntheticBiologics Investigational Site, Tychy, Poland
A Study of the Effect of SYN-010 on Subjects With IBS-C
- Conditions
- Irritable Bowel Syndrome With Constipation (IBS-C)
- Interventions
- Drug: PlaceboDrug: SYN-010 42 mgDrug: SYN-010 21 mg
- First Posted Date
- 2015-07-13
- Last Posted Date
- 2018-11-27
- Lead Sponsor
- Theriva Biologics, Inc.
- Target Recruit Count
- 63
- Registration Number
- NCT02495623
- Prev
- 1
- 2
- Next
News
Theriva Biologics Presents Phase 1b/2a Safety Data for SYN-004 in Hematopoietic Cell Transplant Recipients at ESCMID Global
Theriva Biologics announced the presentation of blinded safety and pharmacokinetic data from its ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients at the ESCMID Global congress in Vienna.
Theriva Biologics Receives FDA Guidance on Phase 3 Design for VCN-01 in Metastatic Pancreatic Cancer
Theriva Biologics received FDA guidance on the Phase 3 study design for VCN-01 in metastatic pancreatic cancer, advising against expanding the Phase 2b VIRAGE study.
VCN-01 Receives Orphan Drug Designation from European Commission for Retinoblastoma Treatment
Theriva Biologics' VCN-01, an oncolytic adenovirus, has been granted orphan medicinal product designation by the European Commission for retinoblastoma treatment.
Theriva Biologics' SYN-004 Shows Positive Safety Profile in Phase 1b/2a Trial for aGVHD Prevention
The Data and Safety Monitoring Committee (DSMC) has recommended advancing Theriva Biologics' SYN-004 trial to Cohort 3 after reviewing Cohort 2 data.
Theriva Biologics Completes Enrollment in Phase 2b VIRAGE Trial of VCN-01 for Metastatic Pancreatic Cancer
Theriva Biologics has achieved target enrollment of 92 patients in its Phase 2b VIRAGE trial for metastatic pancreatic ductal adenocarcinoma (PDAC).
FDA Grants Fast Track Designation to VCN-01 for Metastatic Pancreatic Cancer
The FDA has granted Fast Track designation to VCN-01 in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic adenocarcinoma.