Vivacelle Bio and University of Missouri-Kansas City School of Medicine Announce Groundbreaking Results from Phase 2a Clinical Trial of VBI-S for Refractory Hypotension in Severe Septic Shock Patients

KANSAS CITY, Mo., Feb. 29, 2024 /PRNewswire/ -- Today, researchers at Vivacelle Bio, Inc., a pioneering biotechnology company revealed the compelling outcomes of their phase 2a clinical trial of the investigational cardiovascular support fluid, VBI-S, in patients with severe septic shock. This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.

Unlike previous septic shock trials, this study, conducted in collaboration with the University of Missouri- Kansas City School of Medicine, there were no restrictions on the severity or duration of the illness or the cardiorespiratory stability of the enrolled patients. Some patients were unstable when given VBI-S. Yet the primary endpoint was achieved in each case. Twenty patients with high doses of vasopressors, multiple organ system failure, and a severely dysregulated response to infection were enrolled in the study.

Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide. The results were astonishing, with VBI-S proving 100% effective in elevating mean blood pressure by 10 mmHg or more. Within just 48 hours of the infusion, there were statistically significant improvements across multiple parameters, including oxygenation, renal function, inflammation, lactic acid levels, prothrombin time, and international normalized ratio. Furthermore, the sequential organ failure assessment (SOFA) score, a key indicator of illness severity, showed a notable decrease, signifying improved patient conditions. Remarkably, no serious adverse events were attributed to VBI-S.

Sepsis, affecting 49 million people worldwide and claiming eleven million lives annually, poses a significant global health challenge. In the United States alone, 357,000 people succumb to sepsis each year. The efficacy and safety demonstrated by VBI-S in reversing hypotension, inflammation, and organ failure in septic shock patients suggest a potential paradigm shift in treating sepsis with its associated high mortality and morbidity.

Dr. Cuthbert Simpkins, MD, the Sosland Missouri Endowed Chair in Trauma Services at the University of Missouri Kansas City School of Medicine and Chief Innovation Officer of Vivacelle Bio, Inc. stated, "This study was initially intended as a pilot to determine the variability of VBI-S effects. We did not expect the convincing results that we obtained. These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients."

Harven DeShield, J.D., Ph. D., CEO of Vivacelle Bio, added, "Ultimately, the availability, affordability, and accessibility of VBI-S would represent a paradigm shift, substantially transforming how septic shock is treated both in the US and globally upon FDA's clearance of VBI-S to be marketed to the public."

In a statement, Rod Cotton, 2Flo Ventures Advisory Board Member said, "The publication of  these clinical trial results in such a highly regarded peer reviewed journal is evidence of the importance of Vivacelle Bio's technology. This article is the introduction of a new concept of medical intervention that will revolutionize the treatment of sepsis and a broad-spectrum of medical conditions bringing hope to patients and their families." 2Flo Ventures is a startup studio and venture capital firm, and investor in Vivacelle Bio.

This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide. The implications of VBI-S in reshaping the landscape of septic shock treatment are promising, marking a significant step forward in the fight against this life-threatening condition.

This work was supported by the Naval Medical Research Command (NMRC) - Naval Advanced Medical Development (NAMD) Program under MTEC award 20-02-NavyMultiTopic-002.

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.

About 2Flo Ventures

2Flo Ventures is a startup studio and venture capital firm dedicated to accelerating equitable innovation in healthcare. They invest in diverse healthcare entrepreneurs and companies built to close gaps in health outcomes for underserved communities.

About Vivacelle Bio
Vivacelle Bio (www.vivacellebio.com) is a life sciences company that utilizes patented phospholipid nanoparticle technology to design products that increase the survivability of critically-ill patients. In addition to VBI-S and VBI-1, Vivacelle Bio has a pipeline of products at various stages of development applicable to a range of health areas including reperfusion injury, organ preservation and transplantation, multiple organ dysfunction syndrome and hyperprocalcitonemia.  Vivacelle Bio has raised approximately $10.9M in seed and Series A1-A3 funding, including from the US Department of Defense, the US National Institutes of Health, and 2Flo Ventures.  

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SOURCE Vivacelle Bio