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Theriva Biologics

Theriva Biologics logo
🇺🇸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.

Multiple Ascending Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Orally Administered SYN 020

Phase 1
Completed
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

Phase 1
Completed
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

Phase 1
Active, not recruiting
Conditions
Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant
Prevention 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

Phase 2
Completed
Conditions
Clostridium Infections
Clostridium 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, Bucharest, Romania

🇵🇱

SyntheticBiologics Investigational Site, Tychy, Poland

🇷🇸

Synthetic Biologics Investigational Site, Čačak, Serbia

A Study of the Effect of SYN-010 on Subjects With IBS-C

Phase 2
Completed
Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
Drug: Placebo
Drug: SYN-010 42 mg
Drug: 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

A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C

Phase 2
Completed
Conditions
Irritable Bowel Syndrome With Constipation (IBS-C)
Interventions
First Posted Date
2015-07-09
Last Posted Date
2018-11-27
Lead Sponsor
Theriva Biologics, Inc.
Target Recruit Count
54
Registration Number
NCT02493036

A Study Evaluating the Effect of Esomeprazole on SYN-004 Degradation of Ceftriaxone In Adults With an Ileostomy

Phase 1
Completed
Conditions
Healthy Volunteers With Ileostomy
Interventions
First Posted Date
2015-06-16
Last Posted Date
2018-11-27
Lead Sponsor
Theriva Biologics, Inc.
Target Recruit Count
15
Registration Number
NCT02473640
Locations
🇨🇦

Synthetic Biologics Investigative Site, Montreal, Canada

A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Period 1 - Treatment Sequence AB
Drug: Period 1 - Treatment Sequence AC
Drug: Period 2 - Treatment Sequence AB
Drug: Period 2 - Treatment Sequence AC
First Posted Date
2015-04-17
Last Posted Date
2018-11-27
Lead Sponsor
Theriva Biologics, Inc.
Target Recruit Count
11
Registration Number
NCT02419001
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