Theriva Biologics Showcases Promising Clinical Data for SYN-004

Highlighting Significant Clinical Advancements in Onco-Therapies

Theriva Biologics, a dynamic and innovative clinical-stage biotech firm, has recently revealed key data from its ongoing clinical trial of SYN-004 (ribaxamase). This trial is uniquely aimed at aiding allogeneic hematopoietic cell transplant (HCT) recipients in preventing acute graft-versus-host-disease (aGVHD). As a leader in developing therapeutics for cancer and other critical conditions, Theriva Biologics continues to emphasize the importance of addressing high unmet medical needs.

Presentation at Renowned Medical Congress

The latest findings from this significant clinical trial were shared at the prestigious Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). This event, held in Vienna, gathered experts and stakeholders from around the world, marking an essential platform for presenting innovative medical insights.

Insights from the Clinical Trial of SYN-004

The Phase 1b/2a clinical trial is randomized, involving double-blind and placebo-controlled frameworks. It aims to assess the safety and pharmacokinetics of SYN-004 in patients who have undergone allogeneic HCT. The trial specifically targets patients receiving intravenous antibiotics to manage febrile conditions.

Key safety data focused on the administration of SYN-004 during two distinct antibiotic treatments: meropenem and piperacillin/tazobactam. Participants enter the trial in three cohorts, each evaluated based on the type of antibiotic they receive. Meropenem, known for its effectiveness against infections but not metabolized by SYN-004, serves as the study-assigned antibiotic for one group.

Promising Data on Safety and Tolerability

During the presentation, Dr. Erik R. Dubberke, a medical expert in transplant infectious diseases, unveiled findings demonstrating the safety and tolerability of SYN-004 among HCT patients. The clinical investigation has garnered attention for showing potential protective effects of SYN-004 on the gut microbiome, an area critical for patients on antibiotic regimens.

The Role of SYN-004 in Gut Microbiome Protection

SYN-004 has emerged as a crucial oral prophylactic therapy designed to maintain the gut microbiome's natural balance while combating the adverse effects typically associated with long courses of IV beta-lactam antibiotics. A previously conducted Phase 2b clinical trial revealed SYN-004's capacity to protect the gut microbiome from antibiotic-induced dysbiosis. The findings indicate that patients receiving SYN-004 experienced enhanced recovery of their gut microbiome, leading to lower incidents of opportunistic infections and associated complications.

The dual functionality of SYN-004 targets Clostridioides difficile infection (CDI), fighting the overgrowth of pathogenic organisms while mitigating the risks of antimicrobial resistance in vulnerable patient populations.

Continuing Commitment to Medical Innovation

Theriva Biologics, with its stock trading on NYSE American under the ticker TOVX, is at the forefront of biotherapeutics development. It focuses on creating effective treatments in areas where traditional methodologies have fallen short. Their portfolio includes several next-generation therapies, with SYN-004 positioned as a promising candidate for improving outcomes in HCT recipients.

The firm is dedicated to moving forward with its clinical programs, continuously striving to meet critical medical needs and enhance overall patient outcomes. Detailed information about their ongoing research and initiatives is accessible on their official website.

Ongoing Research and Future Directions

As research advances, Theriva Biologics remains committed to sharing insights and findings with the medical community and stakeholders. The company's future trials aim to expand the understanding of SYN-004's therapeutic potential and its impact on patient care within the realm of hematological conditions.

Frequently Asked Questions

What is SYN-004 used for?

SYN-004 is an oral therapy that aims to degrade IV beta-lactam antibiotics in the gastrointestinal tract, protecting the gut microbiome and supporting patient recovery in HCT recipients.

Why is the gut microbiome important for HCT recipients?

The gut microbiome plays a crucial role in immune function and overall health. Maintaining its balance helps prevent infections and complications in patients who undergo HCT.

Who presented the data at the ESCMID Global Congress?

Dr. Erik R. Dubberke, a Professor of Medicine and Clinical Director of Transplant Infectious Diseases at Washington University School of Medicine, presented the findings.

What does the Phase 1b/2a trial involve?

This trial evaluates the safety and pharmacokinetics of SYN-004 in allogeneic HCT recipients, focusing on those receiving specific IV antibiotics to manage febrile conditions.

How can I find more information about Theriva Biologics?

For additional details on Theriva Biologics and its research, you can visit their official website.

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