Vivacelle Bio Initiates Phase 3 Trial for Lead Asset VBI-S to Treat Patients with Hypovolemia Due to Septic Shock

Vivacelle's VBI-S is designed to treat hypovolemic patients in urgent need of care due to septic shock

Septic shock impacts approximately two million people in the U.S. each year, the leading cause of hospital-related mortality and a major financial burden for the medical system

KANSAS CITY, Mo., July 23, 2024 /PRNewswire/ -- Vivacelle Bio, a late-stage biopharma company developing life-saving treatments for shock and trauma, today announced the initiation of a Phase 3 trial for its lead therapeutic candidate, VBI-S, to treat hypovolemic septic shock, a leading cause of death that impacts millions globally. VBI-S is built on the company's pioneering and patented phospholipid nanoparticle technology, which leverages the redistribution of nitric oxide to elevate blood pressure in patients with hypovolemic septic shock.

The open-label, randomized, controlled Phase 3 trial will enroll 40 septic shock patients across 7 planned sites in the U.S., including some of the largest septic shock treatment centers in the country, and will compare VBI-S and standard of care (SOC) to SOC alone in a 1:1 ratio. 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. Patients in the Phase 3 trial will have failed attempts to raise blood pressure to a survivable level using standard fluids and will be on vasopressors which may produce severe life-threatening complications.

The Phase 3 study design, which has been cleared by the U.S. Food and Drug Administration (FDA), builds on the recently completed Phase 2a trial in which VBI-S demonstrated 100% efficacy and achieved its primary endpoint of increasing mean arterial blood pressure (MAP) by at least 10 mmHg with a target of 60-65 mmHg in hypovolemic septic shock patients whether they were hyporesponsive or unresponsive to vasopressors. The 100% efficacy demonstrated in Phase 2a is believed to provide a strong prognosticator of its success in Phase 3. Additionally, the Phase 2a study showed improved survivability from 10% to 70% with no drug-related severe adverse effects. Results from the study were published in The Lancet eClinicalMedicine in February 2024.

"Initiation of our Phase 3 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. "Based on our excellent Phase 2 results, and the positive interaction with the FDA affirming our Phase 3 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, which 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 results from whole body infection resulting in lower blood pressure and is associated with a third of all hospital deaths in the U.S., making it both the most significant cause of hospital related mortality and the most expensive. Globally more deaths are caused from sepsis than cancer each year (11M vs. 9.6M) including 3.4M children.

VBI-S has the potential to be the first successful treatment of septic shock that is mediated primarily by overproduction of nitric oxide. For decades, research has established  that endogenously produced nitric oxide plays a major role in the pathogenesis of septic shock¹.

"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 amongst 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 Dr. Michael Moncure, MD, FACS, Professor Department(s) of Surgery of University Health/Truman Center, UMKC School of Medicine.

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).

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 40 patients with a SOFA score >/= 5 who meet additional inclusion 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 looks at the lowered dosing of vasopressors. Study endpoints will also measure improved lung and kidney function, improved perfusion, and reduced inflammation. 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 product, Phase 3-ready 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.

Contact

Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

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[email protected]

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

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

SOURCE Vivacelle Bio