Septic shock remains a critical challenge in healthcare, and Vivacelle Bio has launched a Phase III clinical trial for its leading therapeutic candidate, VBI-S, designed to treat hypovolemic septic shock. This pivotal trial will be conducted across seven major septic shock treatment centers in the United States, involving some of the country’s most significant centers for septic shock care. The trial aims to compare the efficacy of VBI-S combined with the standard of care (SOC) against SOC alone, following a 1:1 randomization ratio.
“Initiation of our Phase III trial is a significant achievement for our team following years of dedicated work developing our phospholipid nanoparticle technology platform,” said Harven DeShield, PhD, JD, MSc, CEO of Vivacelle, in a press release.
“Based on our excellent Phase II results and the positive interaction with the FDA affirming our Phase III design, we are excited to initiate this pivotal trial of VBI-S to investigate its ability to improve blood pressure and reverse organ failure in hypovolemic septic shock, an area of immense need that remains underserved by the current standard of care. We are grateful for the ongoing support from the U.S. Department of Defense and the NIH, and we look forward to working with the dedicated medical professionals and researchers across the various sites to advance this important clinical trial.”
Septic Shock Clinical Trial: FDA-Cleared Study Enrolls Patients to Test New Treatment for Severe Cases
The open-label, randomized, controlled trial, cleared by the FDA, will enroll 40 patients who have not responded adequately to standard treatments and are on vasopressors. Additionally, the trial will include 406 patients with a SOFA score of ≥5 who meet further inclusion criteria for a 48-hour treatment period. The primary endpoint is an increase in the mean arterial blood pressure (MAP) by at least 10 mmHg, targeting a MAP of 60-65 mmHg. Vivacelle indicated that patients in this trial will have failed attempts to raise blood pressure to a survivable level using standard fluids and will be on vasopressors, potentially resulting in life-threatening complications.
Previously, Vivacelle’s Phase IIa trial demonstrated 100% efficacy in achieving the primary endpoint of raising MAP by at least 10 mmHg and improving patient survival from 10% to 70% without severe drug-related adverse effects. Full results were published in The Lancet eClinicalMedicine in February. VBI-S is based on Vivacelle’s phospholipid nanoparticle technology, which redistributes nitric oxide to increase blood pressure in septic shock patients. The company believes it has the potential to be the first successful treatment of septic shock primarily mediated by the overproduction of nitric oxide. Research has suggested that endogenously produced nitric oxide plays a key role in the pathogenesis of septic shock.
“Treating patients undergoing septic shock remains one of the greatest challenges in the U.S. healthcare system and poses an even greater problem in other parts of the world among adult and pediatric patients. Given this need, we welcome the opportunity to continue our work with the Vivacelle team in their efforts to bring innovation to the front lines of critical care patient treatment,” said Michael Moncure, MD, FACS, Professor in the Department of Surgery at University Health/Truman Center, UMKC School of Medicine.
Septic Shock Research: NMRC and MTEC Fund Study Highlighting Critical Need for Innovative Treatments
The study is funded by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) program via the Medical Technology Enterprise Consortium (MTEC). The support from these organizations underscores the critical need for innovative treatments for septic shock, a condition that significantly impacts patient outcomes worldwide. The trial’s rigorous design and the collaboration with leading septic shock treatment centers aim to provide robust data on the efficacy and safety of VBI-S. The primary endpoint focuses on a meaningful increase in MAP, which is crucial for patient survival and recovery. Secondary endpoints will likely include metrics on organ function and overall patient survival rates, providing a comprehensive understanding of VBI-S’s impact.
Vivacelle Bio’s dedication to addressing the unmet needs in septic shock treatment is evident in their commitment to advancing VBI-S through this Phase III trial. The company’s innovative approach, leveraging phospholipid nanoparticle technology, represents a novel strategy in managing septic shock, potentially transforming the standard of care. As the trial progresses, the medical community will closely watch for updates and results, which could pave the way for new, effective treatments for septic shock. The positive outcomes from the Phase IIa trial provide a strong foundation for optimism, and the Phase III trial will be crucial in confirming these findings and potentially bringing a new therapeutic option to patients in critical need.
In summary, Vivacelle Bio’s launch of the Phase III clinical trial for VBI-S signifies a major step forward in the quest to improve outcomes for patients with hypovolemic septic shock. The trial’s design, collaboration with top treatment centers, and robust support from key medical research entities highlight the potential of VBI-S to become a groundbreaking treatment in the field of critical care.
Resource: PR Newswire, July 23, 2024

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