ROCKVILLE, Md. - Theriva Biologics, Inc. (NYSE American: TOVX), a clinical-stage company focused on developing treatments for cancer and related diseases, has announced positive outcomes from the second cohort of its phase 1b/2a clinical trial for SYN-004 (ribaxamase). The trial aims to prevent acute graft-versus-host-disease (aGVHD) in recipients of allogeneic hematopoietic cell transplants (HCT).
The Data and Safety Monitoring Committee (DSMC) reviewed data from 19 patients who received at least one dose of SYN-004 or a placebo, with 18 patients receiving at least one dose of the IV antibiotic piperacillin/tazobactam. The study remains blinded, but initial findings indicate that adverse events (AEs) and serious adverse events (SAEs) were typical for allo-HCT patients and not related to the study drug. No patients died within 30 days post-treatment, and no patient blood samples were positive for SYN-004, suggesting it does not enter the bloodstream.
The pharmacokinetics of piperacillin were as expected, leading the DSMC to recommend proceeding to the third cohort, where SYN-004 will be administered with the IV antibiotic cefepime. Steven A. Shallcross, CEO of Theriva Biologics, expressed gratitude for the support from Washington University and highlighted the potential of SYN-004 to improve standard treatments for susceptible patients.
The ongoing trial, conducted at Washington University School of Medicine in St. Louis, evaluates the safety, tolerability, and potential absorption of oral SYN-004 in allogeneic HCT recipients receiving IV antibiotics. The study also investigates SYN-004's possible protective effects on the gut microbiome and preliminary therapeutic benefits for patients.
SYN-004 is designed to degrade certain IV beta-lactam antibiotics in the gastrointestinal tract to preserve the gut microbiome and prevent complications like CDI, AMR, and aGVHD. Previous trials have shown SYN-004's ability to protect the gut microbiome from antibiotic-induced dysbiosis and reduce colonization by pathogenic organisms.
Theriva Biologics is advancing multiple clinical-stage therapeutics, including SYN-004, to address areas with significant unmet medical needs. The company's press release contains forward-looking statements regarding SYN-004's clinical advancement and therapeutic potential, as well as the company's plans for future funding and trial enrollment. This article is based on information provided in a press release statement from Theriva Biologics, Inc.
In other recent news, Theriva Biologics, a clinical-stage biopharmaceutical company, has announced a reverse stock split of its common stock at a 1-for-25 ratio. This decision aims to meet the NYSE American's per-share price requirements and will reduce the number of outstanding common shares from approximately 25.1 million to around 1 million. Additionally, the company has been granted Rare Pediatric Drug Designation (RPDD) by the U.S. Food and Drug Administration (FDA) for VCN-01, its leading product candidate for treating retinoblastoma, a rare type of eye cancer in children.
Moreover, the FDA has also granted Fast Track Designation (FTD) to Theriva's VCN-01 for treating metastatic pancreatic adenocarcinoma in combination with chemotherapy drugs. The VIRAGE Phase 2b trial, investigating the efficacy of VCN-01 as a first-line therapy for patients with pancreatic ductal adenocarcinoma, is expected to complete patient enrollment by the third quarter of 2024.
These are recent developments in Theriva Biologics' ongoing commitment to address unmet medical needs in oncology. The FDA's designations underscore the potential of Theriva's leading product candidate, VCN-01, in treating serious and life-threatening conditions. The company continues to advance its clinical programs and aims to improve treatment outcomes for patients with retinoblastoma.
InvestingPro Insights
As Theriva Biologics (NYSE American: TOVX) progresses with its clinical trials for SYN-004, investors should be aware of some key financial metrics and insights provided by InvestingPro.
According to InvestingPro data, Theriva Biologics has a market capitalization of $1.68 million, reflecting its status as a small-cap biotechnology company. The company's Price to Book ratio stands at a low 0.06, which could indicate that the stock is undervalued relative to its assets. This aligns with an InvestingPro Tip suggesting that the stock is "trading at a low Price / Book multiple."
However, investors should exercise caution. An InvestingPro Tip notes that the company is "quickly burning through cash," which is not uncommon for clinical-stage biotech firms but requires careful monitoring. Additionally, the company's operating income for the last twelve months as of Q2 2024 was -$21.55 million, underscoring the significant costs associated with drug development and clinical trials.
The stock's recent performance has been challenging, with InvestingPro data showing a one-month price total return of -69.83% and a one-year return of -89.88%. This aligns with another InvestingPro Tip indicating that the "stock has taken a big hit over the last week" and has "fared poorly over the last month."
For investors considering Theriva Biologics, it's worth noting that InvestingPro offers 17 additional tips for this stock, providing a more comprehensive analysis of its financial health and market position. These insights can be particularly valuable for those looking to make informed decisions in the volatile biotech sector.
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