Piperacillin/tazobactam

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

Retrieved on: 
Thursday, February 16, 2023
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ROCKVILLE, Md., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the presentation of blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). These data will be featured in a poster presentation at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held in Orlando, Florida from February 15-19, 2023.

Key Points: 
  • These data will be featured in a poster presentation at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, being held in Orlando, Florida from February 15-19, 2023.
  • “SYN-004 (ribaxamase) is intended to address key limitations of broad-spectrum IV beta-lactam antibiotics and potentially improve treatment outcomes with this important and widely used class of therapeutics.
  • We are encouraged by the favorable safety/tolerability profile and growing evidence from our initial meropenem (MER) cohort that supports the clinical advancement of SYN-004,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
  • Consistent with previous studies of SYN-004 in healthy volunteers, SYN-004 was not observed in blood samples from the majority of the evaluable patients.

Theriva Biologics Announces First Patient Dosed in Second Cohort of Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

Retrieved on: 
Thursday, November 3, 2022
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ROCKVILLE, Md., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the first patient has been dosed in Cohort 2 of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

Key Points: 
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • The trial is designed to evaluate the safety, tolerability, and potential absorption of oral SYN-004 (150 mg q.i.d.
  • for a maximum of 28 days) into the systemic circulation of allogeneic HCT recipients who receive an IV antibiotic to treat fever.
  • Patients in Cohorts 2 and 3 will be administered piperacillin/tazobactam and cefepime respectively, each of which can be metabolized by SYN-004.

Allecra Therapeutics Publishes Final Phase 3 ALLIUM Data in JAMA: Cefepime/Enmetazobactam Met Criteria for Superiority

Retrieved on: 
Wednesday, October 5, 2022
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The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Key Points: 
  • The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
  • Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
  • Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

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

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Tuesday, September 27, 2022
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ROCKVILLE, Md., Sept. 27, 2022 (GLOBE NEWSWIRE) -- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the first Cohort of its Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD).

Key Points: 
  • A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations including sepsis.
  • None of the three ECL positive plasma samples were found to contain active SYN-004 using a functional enzyme activity assay.
  • The ongoing randomized, double-blinded, placebo-controlled Phase 1b/2a clinical trial is being conducted at Washington University School of Medicine in St. Louis.
  • A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis.

Allecra Therapeutics and ADVANZ PHARMA Sign Exclusive License and Supply Agreement for Allecra’s Antibiotic Cefepime/enmetazobactam in Europe

Retrieved on: 
Thursday, January 13, 2022
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ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA"), a specialty pharmaceutical company with a strategic focus on hospital medicines in Europe, and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive license agreement under which ADVANZ PHARMA gains the rights to develop and commercialize Allecras antibiotic drug candidate cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.

Key Points: 
  • ADVANZ PHARMA Corp. Limited ("ADVANZ PHARMA"), a specialty pharmaceutical company with a strategic focus on hospital medicines in Europe, and Allecra Therapeutics (Allecra) today announced that the companies have signed an exclusive license agreement under which ADVANZ PHARMA gains the rights to develop and commercialize Allecras antibiotic drug candidate cefepime/enmetazobactam within the European Union, the United Kingdom, Switzerland, and Norway.
  • In exchange for the exclusive license, Allecra will receive an upfront payment and development and sales milestones for cefepime/enmetazobactam, as well as double-digit tiered royalties.
  • In addition, the two companies have signed a supply agreement under which Allecra will supply the cefepime/enmetazobactam finished product in the agreed upon territories.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.