VBI-S Phase 2a Trial Success in Severe Septic Shock

In a recent breakthrough, Vivacelle Bio, a leading biotech firm, has announced the successful results of a phase 2a clinical trial for a novel cardiovascular support fluid, VBI-S, aimed at treating patients with severe septic shock. The study, conducted in partnership with the University of Missouri-Kansas City School of Medicine and published in the Lancet's eClinicalMedicine, demonstrates the transformative potential of VBI-S in addressing refractory hypotension in critically ill patients.
The research was unique as it did not limit the inclusion of patients based on the severity or duration of their condition or their cardiorespiratory stability. The trial included twenty participants who had experienced multiple organ system failure and a severe response to infection, despite high doses of vasopressors. These patients were administered VBI-S intravenously, a treatment composed of phospholipid nanoparticles designed to temporarily bind to nitric oxide, leading to a remarkable 100% effectiveness in raising mean blood pressure by at least 10 mmHg.
Significant improvements were observed within 48 hours post-infusion across various health metrics, such as oxygenation, renal function, inflammation, lactic acid levels, prothrombin time, and the international normalized ratio. Additionally, the SOFA score, which measures the severity of a patient's condition, decreased, indicating better patient outcomes. Notably, no serious adverse effects were linked to VBI-S.
Sepsis is a global health crisis, affecting nearly 49 million individuals globally and resulting in 11 million fatalities annually. In the U.S., over 357,000 deaths are attributed to sepsis each year. The effectiveness and safety profile of VBI-S in countering hypotension, inflammation, and organ failure in septic shock patients could signal a new approach to managing this deadly condition.
Dr. Cuthbert Simpkins, MD, a key figure in the study and Chief Innovation Officer at Vivacelle Bio, expressed surprise at the positive outcomes, which were initially sought to gauge the variability of VBI-S's impact. Harven DeShield, CEO of Vivacelle Bio, highlighted the potential for VBI-S to alter the treatment of septic shock, both domestically and internationally, once approved by the FDA.
Rod Cotton, a member of the advisory board at 2Flo Ventures, a venture capital firm that has invested in Vivacelle Bio, emphasized the significance of the publication in a prestigious journal, suggesting that VBI-S could revolutionize sepsis treatment and benefit a wide array of medical conditions.
The study was supported by the Naval Medical Research Command's Naval Advanced Medical Development Program. Vivacelle Bio, which has developed patented phospholipid nanoparticle technology, is also working on a range of products for conditions such as reperfusion injury and organ preservation. The company has secured approximately $10.9 million in funding from various sources, including the US Department of Defense and the US National Institutes of Health.