Surge in Septic Shock Care: Vivacelle’s Innovative Approach

We had the chance to sit down with Harven DeShield, Chief Executive Officer and Co-founder of Vivacelle Bio. We explored Vivacelle’s new phase three study for the treatment of hypovolemia due to septic shock, focusing on the trial design, challenges, and innovative approaches that may revolutionize treatment.

Moe: Can you describe the design of Vivacelle’s new phase three trial for septic shock, including the patient population and study endpoints?

Harven: Our phase three trial is an open-label, randomized, and controlled study with two arms. Twenty patients will receive standard care, which includes vasopressors after fluid therapy has failed, while the other twenty patients will receive our drug in addition to standard care. The primary endpoint is to increase the mean arterial blood pressure by at least 10 millimeters of mercury. The secondary endpoint focuses on reducing the dosage of vasopressors, which are known for their toxicity and significant safety concerns.

Additionally, there are tertiary endpoints related to organ dysfunction, such as improvements in kidney, lung, and liver function and reductions in inflammation and lactic acid levels. These are critical components of septic shock treatment. We aim to replicate the promising results from our phase two study, which showed significant improvements in these areas. For example, reducing vasopressor dosage is crucial because their toxic nature can lead to severe complications, and our goal is to provide a safer, more effective treatment option.

criteria of SOFA score of 5 (about 50% mortality rate), clinicians may also be hesitant to enroll patients with a high risk of death on an experimental drug. Additionally, at the high end of our inclusion criteria of an initial SOFA score of 11 (greater than 90% mortality rate, families of patients with severe conditions often opt for palliative care rather than trial participation.

To address these challenges, we are starting with more clinical trial sites and focusing on locations with high patient volumes. For instance, during the first trial, recruitment was difficult because some families preferred palliative care. Additionally, we have achieved approval to begin with at least six active recruiting sites.  We expect an additional site to also participate eventually. These measures should help us overcome the significant hurdles in patient recruitment and enrollment, ensuring we can replicate the impressive results seen in phase two.

Moe: What innovative approaches are you taking in designing and executing this trial? How are you collaborating with sites to overcome these challenges?

Harven: Two of our most robust sites from the first trial are participating again, and they recruited over 50% of the patients. This familiarity will create efficiency and improve execution. Additionally, we have selected a diverse range of sites nationwide, each with different capabilities and expertise in treating septic shock patients. This geographical spread will help us recruit a broad and diverse patient population.

For example, one of our sites treats about 5,000 sepsis patients annually, which could significantly speed up enrollment. By leveraging the experience of these sites and ensuring a geographical spread, we aim to address the logistical and operational challenges faced in the previous trial. Our collaboration with these well-known sites, known for their expertise in critical care, will enhance the efficiency and effectiveness of the trial, ultimately helping us achieve our recruitment goals and improve patient outcomes.

Moe: Can you explain the mechanism of action for VIS, the phospholipid nanoparticle tech, and its application to septic shock?

Harven: VBI-S addresses hypovolemia in septic shock, a critical component of treatment. Our drug targets both absolute and relative hypovolemia. Absolute hypovolemia occurs when blood vessels rupture due to a combination of free radicals and excessive nitric oxide, leading to a capillary leak. Relative hypovolemia happens when blood vessels are overly dilated from too much nitric oxide, leading to a potentially fatal blood pressure drop. Our drug creates hydrophobic pockets that attract and redistribute nitric oxide to where it’s needed, helping to restore blood pressure.

Additionally, our phase two data showed significant improvements in organ function and reduced inflammation and lactic acid levels, all critical in septic shock. The drug’s mechanism involves binding to nitric oxide and redistributing it to the microvasculature, which is crucial for addressing the excessive dilation and rupture of blood vessels. This redistribution helps normalize blood pressure and improve overall patient outcomes. The phase two trial results were promising, and we aim to replicate these successes in the larger phase three trial.

Moe: Why has Vivacelle not pursued acquisition by Big Pharma as it moves into phase three?

Harven: We are actively pursuing opportunities for acquisition or collaboration with Big Pharma. We’re open to commercialization partnerships, licensing agreements, or an outright sale of the company. This approach remains on the table as we progress with developing our medical products. We believe partnering with a larger pharmaceutical company could provide the extensive resources and market reach needed for successful commercialization.

However, we are also focused on maintaining the flexibility to continue our innovative research and development. We aim to find the best path forward for bringing our promising treatments to market by exploring various options, including potential acquisition. Our goal is to ensure that our medical products reach as many patients as possible, improving outcomes for those suffering from septic shock and other critical conditions. Septic shock impacts approximately two million people in the U.S. each year and is the leading cause of hospital-related mortality as well as a major financial burden for the medical system, so the need for an innovative approach is severely needed.