Vivacelle Bio Enrolls First Patient in Phase 3 Trial of Hypovolemia Due to Septic Shock for Phospholipid Nanoparticle-Based VBI-S

Septic shock results in approximately 350,000 deaths in the U.S. each year, the leading cause of hospital-related mortality and a major financial burden for the medical system

Six trial sites with expertise in critical care across diverse geographies have been approved

KANSAS CITY, Mo., Sept. 3, 2024 /PRNewswire/ -- Vivacelle Bio, a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced that it has enrolled the first patient in a Phase 3 trial for its lead therapeutic candidate, phospholipid nanoparticle-based VBI-S, to treat both absolute and relative hypovolemia due to septic shock and has initiated six trial sites. VBI-S is the first successful treatment for the overproduction of nitric oxide and to address both absolute and relative hypovolemia.

Absolute hypovolemia occurs when there is insufficient volume in blood vessels. Relative hypovolemia occurs when blood vessels are dilated due primarily to the overproduction of nitric oxide. Since the dominant role of nitric oxide in causing hypovolemia was discovered 40 years ago numerous strategies have been tried and failed to control it and reverse its adverse effects.

VBI-S is built on the company's pioneering and patented phospholipid nanoparticle technology, which expands intravascular volume and redistributes nitric oxide to elevate blood pressure and reverse multisystem organ failure in patients with absolute and/or relative hypovolemia due to septic shock. Growing evidence suggests hypovolemia is a critical link to mortality among sepsis patients.

The approved trial sites are leading critical care institutions spread across diverse geographies. Septic shock results from a dysregulated response to an infection resulting in lower blood pressure (BP) and the failure of multiple vital organs. It is associated with 1/3 of all hospital deaths. Sepsis represents the most significant cause of hospital-related mortality and is a major financial burden across healthcare systems. Globally more deaths are caused by sepsis than cancer (11M vs. 9.6M) including 3.4M children.

The open-label, randomized, controlled Phase 3 trial will enroll patients in a 1:1 ratio and will compare VBI-S plus standard of care (SOC) to SOC alone. The primary endpoint for the trial is an increase in the mean arterial blood pressure (MAP) by at least 10 mmHg with a target of 60-65 mmHg. Secondary endpoints will include measurements of the effect of VBI-S on the failure of multiple vital organs. Patients eligible for the Phase 3 trial will have failed attempts to raise their mean arterial blood pressure to a survivable level using standard fluids and will be on vasopressors which may produce severe life-threatening complications and may eventually become ineffective leading to the patient's demise.

"I congratulate our team on enrolling the first patient in our Phase 3 trial for VBI-S, our lead asset built on Vivacelle's patented phospholipid nanoparticle technology, which is designed to restore intravascular volume to raise blood pressure in hypovolemic patients experiencing septic shock and nitric oxide (NO) redistribution that helps mitigate multi-organ failure in these patients," said Harven DeShield, PhD, JD, MSc, CEO of Vivacelle Bio. "Septic shock continues to be a significantly underserved condition that presents numerous challenges, often resulting in sudden fatalities. Our hope is this Phase 3 clinical trial of VBI-S could soon lead to the introduction of new treatment option that offers the potential to improve patient outcomes and save lives."

The Phase 3 septic shock trial design builds on the recently completed Phase 2a study. In that study, VBI-S demonstrated 100% efficacy and achieved its primary endpoint of increasing blood pressure - by at least 10 mmHg in hypovolemic septic shock patients with sub-optimal response to vasopressors. Additionally, the Phase 2a study showed reversal of organ failure of the lungs, kidneys, liver and the blood clotting system. There were no drug-related severe adverse effects. Results from the study were published in The Lancet's eClinicalMedicine in February 2024.

"VBI-S is built on decades of research into the key role of endogenously produced nitric oxide in the pathogenesis of septic shock¹," said Cuthbert Simpkins MD, FACS, CIO, Founder & President of Vivacelle Bio. "As we make this important early progress in our Phase 3 trial, we are excited to advance this innovative technology. VBI-S has the potential to be the first treatment of septic shock that utilizes phospholipid nanoparticles with hydrophobic cores that both expand intravascular volume and reversibly absorbs nitric oxide in the blood vessel, preventing excessive, and damaging vasodilation and redistributing nitric oxide to increase the probability of survival."

"Vivacelle's VBI-S offers a potentially game-changing treatment option to the urgent care setting of septic shock, said Kris Roach, MD, a critical care specialist at Dignity Health, Phoenix, AZ, who's site enrolled the first participant in this trial. "Our team of dedicated healthcare professionals sees these challenging patients every day, and we are thrilled to be working to bring novel, potentially life-saving solutions to the treatment paradigm, which has seen minimal innovation for far too long. Improved tools are severely needed in our advanced treatment setting, and could have an even bigger impact on patients worldwide."

Vivacelle Bio's 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).

About the Phase 3 Trial
The open-label, randomized, controlled Phase 3 study will compare VBI-S and standard of care (SOC) to SOC alone in a 1:1 ratio. The trial will enroll approximately 40 patients with a SOFA score >/= 5 who meet additional inclusion criteria for a 48-hour treatment period. The primary endpoint will assess the increase in mean arterial blood pressure (MAP) by at least 10 mmHg with a target of 60-65 mmHg, while the secondary endpoint will assess a change in dose of vasopressors. Other study endpoints include changes in lung and kidney function, blood perfusion, and inflammatory biomarkers. The study design is similar to the Phase 2a trial and was affirmed by the FDA.

About MTEC
The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org.

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

About Vivacelle Bio
Vivacelle Bio is a late-stage biopharma company developing life-saving treatments for shock and trauma. The company's lead, Phase 3 product, VBI-S, is built on its pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in hypovolemic septic shock, a leading cause of death that impacts millions around the world. A Phase 2 trial of VBI-S demonstrated 100% efficacy, with the treatment resulting in elevated blood pressure in hypovolemic septic shock patients who are refractory to therapy. In addition to venture capital, Vivacelle has garnered backing and financial support from the US Department of Defense and the National Institutes of Health. Vivacelle Bio is headquartered in Kansas City, MO. Learn more at https://www.vivacellebio.com.

¹ Vallance P, Moncada S. Role of endogenous nitric oxide in septic shock. New Horiz. 1993 Feb;1(1):77-86. PMID: 7922396.

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SOURCE Vivacelle Bio