Drugs / Ribaxamase
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04363242 | Apr 2020 → Jul 2023 | carcinoma | Synermore Biologics Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02391727 | May 2015 → Oct 2018 | colorectal cancer, head and neck cancer | Synermore Biologics Co., Ltd. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02473640 | Jun 2015 → Apr 2016 | — | Theriva Biologics, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT02419001 | Mar → Sep 2015 | — | Theriva Biologics, Inc. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02563106 | Oct 2015 → Nov 2016 | Clostridium difficile colitis, Clostridium infectious disease | Theriva Biologics, Inc. | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT04692181 Comparator | Feb 2021 → Sep 2029 expected | acute graft versus host disease | Theriva Biologics, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2024-10-03 | Theriva Biologics, Inc. | Results Theriva™ Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients therivabio.com ↗
DSMC has reviewed the safety and pharmacokinetic data from Cohort 2 and recommended that the study proceed to enroll patients into Cohort 3 |
| 2023-02-16 | Theriva Biologics, Inc. | Results Theriva™ Biologics Announces Presentation of Safety and Pharmacokinetic Data from Cohort 1 of the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients therivabio.com ↗
Analysis of patients receiving meropenem suggest that SYN-004 is well-tolerated with HCT and was not observed in blood samples from the majority of the evaluable patients |
| 2022-09-27 | Theriva Biologics, Inc. | Results Synthetic Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients therivabio.com ↗
Adverse events (AEs) and serious adverse events (SAEs) observed in Cohort 1 were typical of those observed in allo-HCT patients and no AEs or SAEs were determined to be related to study drug treatment by the investigators. |
| 2020-11-10 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Reports 2020 Third Quarter Operational Highlights and Financial Results therivabio.com ↗
Received Notice from the FDA that the SYN-004 (ribaxamase) Phase 1b/2a Clinical Program in Adult Allogeneic HCT Recipients May Proceed as Planned |
| 2018-04-23 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Provides Update on Development of SYN-004 (ribaxamase), for the Prevention of C. difficile Infection therivabio.com ↗
Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics designed to preserve the microbiome to protect and restore the health of patients, today announced that it has preliminary agreement from the U.S. Food & Drug Administration (FDA), on a proposed clinical trial synopsis for its planned Phase 3 clinical trial for SYN-004 (ribaxamase). |
| 2017-05-11 | Theriva Biologics, Inc. | Regulatory SYN-004 (Ribaxamase) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Prevention of Clostridium difficile Infection therivabio.com ↗
Synthetic Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection. |
| 2017-05-04 | Theriva Biologics, Inc. | Results Synthetic Biologics Reports First Quarter 2017 Operational Highlights and Financial Results therivabio.com ↗
Most recently, we shared supportive data from exploratory endpoints in this trial with the CDC demonstrating ribaxamase successfully protected and preserved the naturally occurring composition of the gut microbiome from the dysbiotic effects of IV ceftriaxone, compared to placebo. |
| 2017-01-05 | Theriva Biologics, Inc. | Results Synthetic Biologics’ SYN-004 (ribaxamase) Achieves Primary Endpoint in Phase 2b Trial for C. difficile Infection (CDI) therivabio.com ↗
The study, a randomized, double-blind, placebo controlled trial of 412 patients, met its primary endpoint of significantly reducing C. difficile Infection (CDI). |
| 2016-07-07 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Receives USAN Approval for Generic Name Ribaxamase for Phase 2 Drug Candidate SYN-004 therivabio.com ↗
announced today that the United States Adopted Names Council (USAN) of the American Medical Association has approved the use of “ribaxamase” (Rye-bak’-sa-mase) for Synthetic Biologics’ SYN-004. |
| 2016-05-16 | Theriva Biologics, Inc. | Results Synthetic Biologics Announces Positive Topline Results from Second Phase 2a Clinical Trial of SYN-004 for the Prevention of C. difficile Infection and Antibiotic-Associated Diarrhea therivabio.com ↗
The 150 mg dose strength of SYN-004 was well tolerated by all participants in this clinical trial. |
| 2015-12-01 | Theriva Biologics, Inc. | Results Synthetic Biologics Announces Positive Topline Results from First Phase 2a Clinical Trial of SYN-004, the Company’s Candidate for the Prevention of C. difficile Infection therivabio.com ↗
Evaluation of the chyme from the ileostomized participants indicates that both dosage strengths of SYN-004 (75 mg and 150 mg) degrade residual IV ceftriaxone present in the chyme, supporting the mechanism of action of SYN-004. |
| 2015-09-21 | Theriva Biologics, Inc. | Results Synthetic Biologics Reports First Analysis Demonstrating SYN-004’s Ability to Protect the Microbiome from Damage Caused by IV Antibiotics in a Humanized Pig Model therivabio.com ↗ |
| 2015-05-19 | Theriva Biologics, Inc. | Results Synthetic Biologics’ SYN-004 Microbiome-Protecting Preclinical Data Highlighted in Late-Breaking Poster at Digestive Disease Week® 2015 therivabio.com ↗
In humanized pigs, SYN-004 protected the intestinal microflora from ceftriaxone and maintained the natural balance of the microbiome. |
| 2015-03-19 | Theriva Biologics, Inc. | Results Synthetic Biologics Announces Positive Pharmacokinetics Data from Phase 1a and 1b Trials of SYN-004 to Protect the Microbiome and Prevent C. difficile Infection therivabio.com ↗
The Phase 1a, single-ascending dose PK study provided data to support Synthetic Biologics’ hypothesis that SYN-004 taken orally was not systemically available in the dose range tested. |
| 2015-02-10 | Theriva Biologics, Inc. | Results Synthetic Biologics Announces Positive Topline Results from Phase 1b Trial of SYN-004 to Protect the Microbiome and Prevent C. difficile Infection therivabio.com ↗ |
| 2014-12-22 | Theriva Biologics, Inc. | Results Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection therivabio.com ↗ |
| 2014-11-24 | Theriva Biologics, Inc. | Regulatory Synthetic Biologics Safe-to-Proceed Under IND to Initiate Clinical Trials of SYN-004 for the Prevention C. difficile Infection therivabio.com ↗
We are pleased the FDA completed the 30-day review of our IND and to be initiating clinical trials of the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat, |
| 2014-09-07 | Theriva Biologics, Inc. | Results Synthetic Biologics Highlights New Data from C. difficile Program Presented at the 54th ICAAC therivabio.com ↗
Both SYN-004 and P4A effectively degraded a broad spectrum of commonly used intravenous (IV) antibiotics that can lead to C. difficile infections, including cephalosporins. |
All press releases naming this drug 27 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ribaxamase | “The Oral β-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies.” PMID 28052855 ↗ Feb 20172“Use of ribaxamase (SYN-004), a β-lactamase, to prevent Clostridium difficile infection in β-lactam-treated patients” PMID 30885591 ↗ Mar 2019 “SYN-004, Ribaxamase or Placebo” NCT04692181 ↗ |
| Known as | Ribaxamasa | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989985 ↗ |
| Known as | SYN004 | “Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg” NCT02419001 ↗ |
| Action | Inhibit | “SYN004 might also inhibit cancer cells” NCT02391727 ↗ |
| Modality | Monoclonal antibody | “a monoclonal antibody that binds to the EGF receptor on cancer cells” NCT02391727 ↗ |
| Route | Intravenous | “single IV loading dose of SYN004” NCT02391727 ↗ |
| Target | EGFR | “binds to the EGF receptor on cancer cells” NCT02391727 ↗ |