Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SYN-004 · 2 trials · 3 indications
Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B \[or their respective genes, tcdA and/or tcdB\], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
Concentrations of ribaximase (SYN-004) in intestinal chyme
Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.
Concentrations of ribaximase (SYN-004) in intestinal chyme
| Arm | Type | Description |
|---|---|---|
| SYN-004 | EXPERIMENTAL | SYN-004 150 mg |
| Placebo | PLACEBO_COMPARATOR | Matching placebo |
| 150 mg SYN-004 | EXPERIMENTAL | There will be 2 in-house treatment periods: in Treatment Period 1, subjects will receive 2 oral doses of 150 mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone, and in Treatment Period 2, subjects will receive 2 oral doses of 150mg SYN-004 (two 75 mg capsules) and 1g ceftriaxone in the presence of steady-state esomeprazole; Treatment Periods 1 and 2 will be separated by a 5- to 7-day run-in phase, during which subjects will self-administer 40 mg of esomeprazole once daily (QD) in the morning, at home. |
| Name | Type | Description |
|---|---|---|
| SYN-004 | DRUG | - |
| Placebo | DRUG | - |
| Esomeprazole | DRUG | - |
| Ceftriaxone | DRUG | - |
Inclusion Criteria: * Expected minimum hospital stay of 5 days * Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a macrolide * Clinical diagnosis of moderate to severe lower respiratory tract infection consisting of signs and symptoms of a lower respiratory tract...
SYN-004 is an investigational small molecule being studied for the prevention of Clostridium difficile infection in patients with a lower respiratory tract infection who are receiving ceftriaxone. It has also been evaluated in healthy volunteers with an ileostomy to assess its effect on ceftriaxone degradation.
SYN-004 is designed to degrade ceftriaxone, a commonly used antibiotic, in the gastrointestinal tract. By breaking down ceftriaxone before it reaches the colon, SYN-004 aims to reduce the disruption of the gut microbiome and thereby lower the risk of Clostridium difficile infection.
SYN-004 is being developed by Theriva Biologics, Inc., a company traded on the NYSE American under the ticker symbol TOVX. The company is conducting clinical trials to evaluate the safety and efficacy of SYN-004 in preventing Clostridium difficile infections.
SYN-004 has completed a Phase 2 clinical trial for the prevention of Clostridium difficile infection in patients with a lower respiratory tract infection. It has also completed a Phase 1 trial in healthy volunteers with an ileostomy. SYN-004 is not FDA approved and remains investigational.
SYN-004 has been studied in two completed clinical trials. NCT02563106 was a Phase 2 study in 413 patients with Clostridium difficile or Clostridium infections in the United States, Bulgaria, Canada, Hungary, Poland, Romania, and Serbia. NCT02473640 was a Phase 1 study in 15 healthy volunteers with an ileostomy in Canada.
SYN-004 is also known by the name ribaxamase, though this alternative name is not provided in the available data. It is a distinct investigational agent developed by Theriva Biologics and is not the same as any approved medication for Clostridium difficile infection.