BARDA is collaborating with BioAegis Therapeutics to expand development activities of their novel recombinant protein therapy for critically ill sepsis patient populations.
Sepsis is a life-threatening complication of an infection that occurs when the body has an extreme response to a pathogen, such as bacteria, viruses, fungi, or parasites, and has potential to lead to organ failure and death. Currently, there are no U.S. Food and Drug Administration (FDA)-approved host targeted treatments for sepsis, leaving hospitalized sepsis patients at risk for severe outcomes. In early studies, BioAegis’ recombinant human plasma protein therapeutic candidate, recombinant human gelsolin (Rhu-pGSN), showed potential to broadly treat acute inflammatory disorders like sepsis. Rhu-pGSN may help address the unmet clinical need to restore immune balance in this patient population.
Rhu-pGSN is designed to be a broad-acting threat-agnostic product with the potential to improve immune cell function at sites of injury, resolve inflammation, and aid in pathogen clearance. BioAegis developed Rhu-pGSN as the recombinant form of a naturally occurring human protein. Prior clinical trials showed the candidate had a benign safety profile, and further development may enable new interventional treatment options for hospitalized patients, reduce length of stay and improve clinical outcomes.
The partnership extends BioAegis’ prior research and clinical studies of hospitalized patients with severe COVID-19 in the European Union, by enabling domestic large-scale product manufacturing of the company’s therapeutic candidate. In addition, the company will engage with FDA to file an Investigational New Drug (IND) application and initiate clinical start-up activities for subsequent evaluation in a Phase 2b/3 study in sepsis patients and regulatory activities.
The partnership between BARDA and BioAegis will support regulatory activities and manufacturing readiness in preparation for clinical evaluation of the product candidate in a sepsis patient population. If FDA-approved, Rhu-pGSN could be available in future public health emergencies and in day-to-day medical care for the treatment of sepsis which can arise from any infection or other acute inflammatory indications.
About BioAegis Therapeutics Inc.:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
BioAegis Therapeutics Inc. is a NJ-based clinical stage, private company whose mission is to capitalize on a key component of the body’s innate immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation and infection. BioAegis’ platform is built upon the recombinant form of plasma gelsolin, a highly conserved abundant human protein in healthy individuals. Its role is to keep inflammation localized to the site of injury and to boost the body’s ability to clear pathogens, but normal levels are depleted by diverse inflammatory conditions. Restoring gelsolin levels with the human recombinant form helps immune cells fight infection and controls inflammation so it does not spread and cause damage.