ribaxamase (SYN-004) / Theriva Bio - LARVOL DELTA

Theriva Biologics Reports First Quarter 2025 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses decreased to $3.0 million for the three months ended March 31, 2025, from approximately $3.5 million for the three months ended March 31, 2024. This decrease of 14% is primarily the result of lower indirect cost related to decreased VCN-01 manufacturing costs and lower clinical trial expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by slightly higher clinical trial expenses related to our VIRAGE Phase 2b clinical trial of VCN-01 in PDAC and higher patent expenses related to SYN-020. We anticipate research and development expense to increase as we complete our VIRAGE Phase 2b clinical trial of VCN-01 and plan for our Phase 3 clinical trial of VCN-01 in PDAC, advance our VCN-01 program in retinoblastoma, expand GMP scale-up manufacturing activities for VCN-01, and continue supporting our other preclinical and discovery initiatives."

Commercial • Gastrointestinal Disorder • Immunology • Pancreatic Ductal Adenocarcinoma • Retinoblastoma

Theriva Biologics Announces Presentation of Data from the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients (GlobeNewswire) - "Theriva Biologics...today announced the presentation of the previously disclosed 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 an ePoster Flash Session oral presentation at the Congress of the European Society of
 Clinical Microbiology and Infectious Diseases (ESCMID Global), taking place in Vienna, Austria from April 11-15, 2025."

P1/2 data • Acute Graft versus Host Disease

Theriva Biologics Reports Full-Year 2024 Operational Highlights and Financial Results (GlobeNewswire) - "Recent Program Highlights and Anticipated Milestones:...SYN-004:...Based upon our current available funding and our focus on our clinical development of VCN-01 we do not anticipate that enrollment for the Cohort 3 will commence unless we obtain grant funding, or find a licensee or partner for the SYN-004 development program."

Commercial • Enrollment status • Acute Graft versus Host Disease

SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov) - P1/2 | N=36 | Active, not recruiting | Sponsor: Theriva Biologics, Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P1b/2a ➔ P1/2 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Transplantation

Theriva Biologics Reports Third Quarter 2024 Operational Highlights and Financial Results (GlobeNewswire) - "SYN-004 (ribaxamase): Successfully completed Cohort 2 of the 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)."

Trial status • Acute Graft versus Host Disease

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 (GlobeNewswire) - P1/2 | N=36 | NCT04692181 | Sponsor: Theriva Biologics, Inc. | "Theriva Biologics...today announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the second 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)....Cohort 2 enrolled 19 patients who received at least 1 dose of study drug (SYN-004 or Placebo randomized 2:1). Eighteen (18) patients received at least one dose of intravenous (IV) piperacillin/tazobactam and 12 of these patients completed sufficient doses of IV piperacillin/tazobactam to be evaluable towards the study endpoints....Based on a review of the safety and pharmacokinetic data, the DSMC has recommended that the study proceed to enroll Cohort 3..."

DSMB • P1/2 data • Acute Graft versus Host Disease

Fighting against Clostridioides difficile infection: Current medications. (PubMed, Int J Antimicrob Agents) - "Recent guidelines recommend fidaxomicin and vancomycin as first-line drugs to treat CDI, bezlotoxumab to prevent recurrence, and fecal microbiota transplantation (FMT) for rescue treatment. Currently, researchers are investigating therapeutic antibacterial drugs (e.g., teicoplanin, ridinilazole, ibezapolstat, surotomycin, cadazolid, and LFF571), preventive medications against recurrence (e.g., Rebyota, Vowst, VP20621, VE303, RBX7455, and MET-2), primary prevention strategies (e.g., vaccine, ribaxamase, and DAV132) and other anti-CDI medications in the preclinical stage (e.g., Raja 42, Myxopyronin B, and bacteriophage). This narrative review summarizes current medications, including newly marketed drugs and products in development against CDI, to help clinicians treat CDI appropriately and to call for more research on innovation."

Journal • Review • Infectious Disease • Transplantation

Theriva Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Dosing is underway for 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)....The trial is on track to complete enrollment in the second cohort in H1 2024."

Enrollment status • Acute Graft versus Host Disease

Theriva Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses increased to $4.0 million for the three months ended September 30, 2023, from approximately $2.6 million for the three months ended September 30, 2022. This increase of 56% is primarily the result of higher clinical trial expenses related to our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, offset by decreased expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, Phase 1a clinical trial of SYN-020, and decreased manufacturing expenses related to our Phase 1a clinical trial of SYN-020.We anticipate research and development expenses to increase as we continue enrollment in our VIRAGE Phase 2 clinical trial of VCN-01 in PDAC and our ongoing Phase 1 clinical trial in retinoblastoma, expand GMP manufacturing activities for VCN-01, and continue supporting our VCN-11 and other preclinical and discovery initiatives."

Commercial • Trial status • Eye Cancer • Gastrointestinal Cancer • Immunology • Inflammation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Retinoblastoma • Solid Tumor

SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov) - P1b/2a | N=36 | Recruiting | Sponsor: Theriva Biologics, Inc. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Transplantation

Theriva Biologics Reports First Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Research and development expenses increased to $3.0 million for the three months ended March 31, 2023, from approximately $2.6 million for the three months ended March 31, 2022. This increase of 15% is primarily the result of increased clinical trial expenses related to VCN-01 not incurred in the prior year, offset by lower expenses related to our Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients....The Company anticipates research and development expense to increase as it continues enrollment in its VIRAGE Phase 2 clinical trial of VCN-01 in PDAC, and its ongoing Phase 1 clinical trial in retinoblastoma, expands GMP manufacturing activities for VCN-01, and continues supporting its VCN-11 and other preclinical and discovery initiatives."

Commercial • Acute Graft versus Host Disease • Eye Cancer • Gastrointestinal Cancer • Graft versus Host Disease • Immunology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Retinoblastoma • Solid Tumor

Theriva Biologics Reports First Quarter 2023 Operational Highlights and Financial Results (GlobeNewswire) - "Dosing is underway with plans to complete the second cohort of our Phase 1b/2a clinical study of SYN-004 for the prevention of acute graft-versus-host-disease in bone marrow transplant patients (Q1 2024)."

Trial completion date • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

A Study to Find the MTD of SYN125 in People With Solid Tumors and the MTD of SYN125 With a Fixed Dose of SYN004 in People in Patients With Epithelial Cancers With EGFR Expressions (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Synermore Biologics Co., Ltd. | Recruiting ➔ Active, not recruiting | N=36 ➔ 22 | Trial completion date: May 2022 ➔ Sep 2023 | Trial primary completion date: Feb 2022 ➔ Jul 2023

Combination therapy • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • EGFR

Interim analysis of SYN-004 phase 1b/2a trial in haematopoietic cell transplant (HCT) recipients (ECCMID 2023) - No abstract available

P1/2 data • Transplantation

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects. (PubMed, Biomedicines) - "Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons...The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI."

Journal • Review • Developmental Disorders • Infectious Disease

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 (GlobeNewswire) - P1b/2a | N=36 | NCT04692181 | Sponsor: Synthetic Biologics Inc. | "Theriva Biologics...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)....Cohort 1 of the study enrolled 19 patients who received at least 1 dose of study drug (SYN-004 or Placebo randomized 2:1). Twelve of these patients completed two doses of IV MER to be evaluable towards the study endpoints. While the study is on-going and remains blinded, key findings showcased in the poster presentation (#LBA6) titled 'Interim Analysis of SYN-004 Phase 1b/2a Trial in Hematopoietic Cell Transplant (HCT) Recipients'..."

P1 data • PK/PD data • Acute Graft versus Host Disease • Graft versus Host Disease • Immunology

Interim Analysis of Syn-004 Phase 1b/2a Trial in Hematopoietic Cell Transplant (HCT) Recipients (TCT-ASTCT-CIBMTR 2023) - "This study evaluates the safety, tolerability, and potential absorption of SYN-004 in HCT recipients, divided into three cohorts (meropenem (MER), piperacillin-tazobactam, and cefepime). Interim blinded analyses after the MER cohort suggest SYN-004 is well-tolerated with HCT. SYN-004 detection was uncommon by ECL; functional drug was not detected in blood."

Late-breaking abstract • P1/2 data • Bone Marrow Transplantation • Infectious Disease • Transplantation

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 (GlobeNewswire) - "Initiation of Cohort 2 Follows a Positive Review of Safety and Pharmacokinetic (PK) Data from Cohort 1 by an Independent Data and Safety Monitoring Committee....Theriva Biologics...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)."

Trial status • Acute Graft versus Host Disease • Graft versus Host Disease

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 (GlobeNewswire) - P1b/2a | N=36 | NCT04692181 | Sponsor: Synthetic Biologics Inc. | "Synthetic Biologics...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)....A total of 13 SAEs were reported among 10 patients, with the most common SAE being infections and infestations including sepsis.One patient died 14 days after the last dose of study drug (within the 30-day reporting period) due to sepsis that was not related to study drug....'These encouraging data support the clinical advancement of SYN-004 and build on the growing data that underscore its therapeutic potential. We remain on track to initiate the second cohort in Q4 2022.'"

DSMB • P1/2 data • Trial status • Acute Graft versus Host Disease • Graft versus Host Disease

SYN-004 Safety and Tolerability in Allo-HCT Subjects (clinicaltrials.gov) - P1b/2a | N=36 | Recruiting | Sponsor: Synthetic Biologics Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Transplantation

Synthetic Biologics Reports 2021 Year End Operational Highlights and Financial Results (GlobeNewswire) - "Enrollment progressed in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease; and topline data for this cohort are expected in H1 2022."

Enrollment status • P1/2 data • Acute Graft versus Host Disease • Graft versus Host Disease

Synthetic Biologics Reports Third Quarter 2021 Operational Highlights and Financial Results; Conference Call to be Held Today at 4:30 PM ET (PRNewswire) - "Anticipated Milestones: Topline data readout from the first antibiotic cohort of the SYN-004 Phase 1b/2a clinical trial is expected during Q1 2022....Enrollment in the Company's Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT recipients for the prevention of acute graft-versus-host-disease ('aGVHD') remains ongoing."

Enrollment status • P1/2 data • Acute Graft versus Host Disease • Graft versus Host Disease

How to: prophylactic interventions for prevention of Clostridioides difficile infection. (PubMed, Clin Microbiol Infect) - "There are no proven effective, evidenced-based prophylaxis options for primary CDI. As for secondary prevention, FMT is considered the option of choice in patients with multiple recurrences. Bezlotoxumab can be added to standard treatment for patients at high risk for R-CDI. The most promising strategies are those aimed at reducing changes in intestinal microbiota and development of a new effective non-toxin-based vaccine."

Journal • Review • Infectious Disease • Transplantation

Synthetic Biologics Reports 2021 First Quarter Operational Highlights and Financial Results (PRNewswire) - "Topline data readout from the first antibiotic cohort of the SYN-004 Phase1b/2a clinical trial is expected during Q4 2021...Enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic hematopoietic cell transplant (HCT) recipients is underway...the Company has extended its cash runway into 2023 and has the ability to fully fund its Phase 1b/2a clinical trial of SYN-004...Research and development expenses decreased by 32% to approximately $1.1 million for the three months ended March 31, 2021...The research and development costs incurred during the quarter were primarily related to the Company's...Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients."

Commercial • Enrollment status • P1/2 data • Graft versus Host Disease

Synthetic Biologics begins patient dosing in phase 1b/2a trial of SYN-004 in allogeneic HCT recipients (Pharmabiz) - "Synthetic Biologics, Inc., a diversified clinical-stage company, announced enrollment has commenced and the first patient has been dosed in its Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD)....Dr. Mark A. Schroeder..."

P1/2 data