In Opsonix’s pathogen-extracting therapy, our engineered protein, FcMBL, is incorporated into an extracorporeal medical device to remove infectious agents and their released toxins from circulating blood in patients with systemic infections.
With its unique broad-spectrum activity, Opsonix’s pathogen-extracting therapy enables effective sepsis treatment to be initiated early without having to first identify the disease-causing agent. Many past efforts have focused on approaches that attempted to temper the immune response, which is downstream in the sepsis cascade. Due to the many possible causes of sepsis, in most patients the infectious agent is never determined and physicians treat with antibiotics that are ineffective in some cases where the microbe is a drug-resistant bacterium or a virus, fungus or parasite. Opsonix’s approach is distinct in that we rapidly extract a wide range of sepsis-causing pathogens from blood, including bacteria, fungi, parasites, and viruses, immunogenic debris and toxins responsible for initiating the sepsis cascade, as well as antibiotic-resistant organisms. In preclinical rodent studies published by Opsonix’s Scientific Founders at the Wyss Institute, the FcMBL-based pathogen-extracting therapy was able to reduce pathogen load, reduce corresponding inflammatory cell infiltrate, and reduce the levels of multiple proinflammatory cytokines that play an important role in the sepsis cascade.
In a fast-progressing syndrome like sepsis, the patient’s life depends on rapid delivery of efficacious treatment. Indeed, studies in patients with septic shock have shown that mortality rates increase by 7.6% with every hour that passes before effective antibiotic treatment begins.3 Opsonix’s therapy has major advantages in that it can be promptly administered to patients, without requiring the time-consuming clinical identification of the specific causative pathogen from blood cultures. It also can be used in combination with today’s standard of care with antibiotics, and because it removes antibiotic-resistant organisms equally efficiently, it can be used to clear circulating pathogens when no other therapeutic options are available.
Our FcMBL pathogen-extracting therapy builds upon pioneering studies conducted at the Wyss Institute at Harvard University, including publications in Nature Medicine and Biomaterials. As demonstrated in these studies, the FcMBL pathogen-extracting therapy effectively removed more than 90% of pathogen load from flowing blood, significantly attenuated production of cytokines that drive the sepsis inflammatory cascade, increased survival in animals with lethal endotoxemia, and synergized with conventional antibiotics. Our FcMBL therapy captures living microorganisms, as well as associated immunostimulatory debris and toxins released from microorganisms killed by an effective antibiotic, making it useful not only as a pathogen-extracting therapy but also as a rapid diagnostic for blood-borne infections, as described in a publication in EBioMedicine.
Prior to Opsonix’s launch, our underlying pathogen-extracting therapy was supported by the United States Defense Advanced Research Projects Agency (DARPA) under their Dialysis-Like Therapeutics program with more than $22 million in grant funding to the Wyss Institute.