Vivacelle Bio, a biopharmaceutical company focused on developing treatments for shock and trauma, has announced the initiation of a Phase 3 clinical trial for its lead asset, VBI-S, in patients with hypovolemic septic shock. This condition, characterized by dangerously low blood pressure due to severe infection, is a leading cause of death globally. The trial aims to evaluate the efficacy of VBI-S in improving blood pressure and reversing organ failure in this critical patient population.
Phase 3 Trial Design
The Phase 3 trial is designed as an open-label, randomized, controlled study. It will enroll 40 patients across 7 sites in the U.S., comparing VBI-S plus standard of care (SOC) to SOC alone in a 1:1 ratio. Eligible patients will have failed to respond adequately to standard fluid resuscitation and will be on vasopressors to maintain blood pressure. The primary endpoint is an increase in mean arterial blood pressure (MAP) of at least 10 mmHg, targeting a MAP of 60-65 mmHg.
Promising Phase 2a Results
The Phase 3 study design is based on positive results from a recently completed Phase 2a trial. In this earlier trial, VBI-S demonstrated 100% efficacy in raising MAP by at least 10 mmHg to the target range of 60-65 mmHg in hypovolemic septic shock patients, regardless of their responsiveness to vasopressors. Notably, the Phase 2a study also showed an increase in survivability from 10% to 70% with no drug-related severe adverse effects. These results were published in The Lancet eClinicalMedicine in February 2024.
VBI-S Mechanism of Action
VBI-S is based on Vivacelle Bio's patented phospholipid nanoparticle technology. It works by redistributing nitric oxide, a molecule known to play a significant role in the pathogenesis of septic shock, to elevate blood pressure. Septic shock is often mediated by an overproduction of nitric oxide, leading to vasodilation and dangerously low blood pressure.
The Need for New Therapies
Septic shock is a major healthcare challenge, associated with approximately one-third of all hospital deaths in the U.S. It is also the most expensive cause of hospital-related mortality. Globally, sepsis causes more deaths than cancer each year (11 million vs. 9.6 million), including 3.4 million children. Current treatments often involve fluids and vasopressors, but many patients remain unresponsive, highlighting the need for new therapeutic options.
Expert Commentary
"Treating patients undergoing septic shock remains one of the greatest challenges in the U.S. healthcare system," said Dr. Michael Moncure, MD, FACS, Professor Department(s) of Surgery of University Health/Truman Center, UMKC School of Medicine. "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."
Funding and Support
The Phase 3 study is funded by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) program via the Medical Technology Enterprise Consortium (MTEC).
