Vivacelle Bio Starts Phase 3 Trial for VBI-S to Treat Hypovolemia from Septic Shock

Vivacelle Bio, a biopharmaceutical company based in Kansas City, Missouri, has announced the commencement of a Phase 3 trial for its key therapeutic product, VBI-S, intended to treat hypovolemic septic shock. Septic shock, a severe condition resulting from widespread infection leading to dangerously low blood pressure, affects approximately two million people annually in the United States and is a significant cause of hospital-related deaths.

Vivacelle’s VBI-S is built upon their innovative and patented phospholipid nanoparticle technology aimed at redistributing nitric oxide to stabilize blood pressure in patients suffering from hypovolemic septic shock. This technology could provide a new lifeline for those in need of urgent care, especially when conventional fluids and vasopressors fail to suffice.

The Phase 3 trial will be conducted as an open-label, randomized, controlled study across seven major sites in the United States, including prominent centers specializing in septic shock treatment. The trial aims to enroll 40 patients, evenly divided between those receiving VBI-S combined with the standard of care (SOC) and those receiving SOC alone. The primary endpoint is to achieve an increase in mean arterial blood pressure by at least 10 mmHg, targeting 60-65 mmHg.

The study design is reinforced by successful results from a preceding Phase 2a trial, which demonstrated a 100% efficacy rate for VBI-S. The Phase 2a trial achieved its primary goal of increasing mean arterial blood pressure by at least 10 mmHg in patients who were either hyporesponsive or unresponsive to vasopressors. Additionally, the study revealed a remarkable improvement in patient survivability, from 10% to 70%, with no severe adverse effects related to the drug. These favorable outcomes, published in The Lancet eClinicalMedicine in February 2024, strongly support the potential success of the Phase 3 trial.

Dr. Harven DeShield, CEO of Vivacelle, emphasized the importance of this trial, highlighting the years of dedicated effort by the team to develop their phospholipid nanoparticle technology. He expressed optimism about the Phase 3 trial, citing the promising Phase 2 outcomes and positive interactions with the FDA. Dr. DeShield also acknowledged the critical support from the U.S. Department of Defense and the National Institutes of Health.

Septic shock, resulting from systemic infection and leading to low blood pressure, is responsible for a third of all hospital deaths in the United States. Globally, sepsis causes more deaths than cancer, with approximately 11 million deaths annually, including 3.4 million children. Given these dire statistics, VBI-S has the potential to be a groundbreaking treatment for septic shock by addressing the overproduction of nitric oxide, a key factor in the condition's progression.

Dr. Michael Moncure, a professor at UMKC School of Medicine, noted the significant challenge septic shock poses to the healthcare system. He expressed enthusiasm for collaborating with Vivacelle to bring innovative treatments to critical care settings.

The Phase 3 study is financially supported by the Naval Medical Research Command through the Naval Advanced Medical Development program and the Medical Technology Enterprise Consortium (MTEC). This consortium works under an agreement with the U.S. Army Medical Research and Development Command to advance biomedical technologies.

Vivacelle Bio continues to focus on developing life-saving treatments for shock and trauma. Their lead product, VBI-S, aims to provide a viable treatment option for hypovolemic septic shock, offering hope to millions affected by this life-threatening condition worldwide. The company's efforts are supported by both venture capital and significant backing from U.S. governmental bodies, including the Department of Defense and the National Institutes of Health.