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The blood purification technology is used for the treatment of severe treatment-refectory systematic lupus erythematosus (SLE).
The blood purification technology is used for the treatment of severe treatment-refectory systematic lupus erythematosus (SLE).
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Santersus AG announced FDA has granted Breakthrough Device Designation to its NucleoCapture blood purification technology for the treatment of SLE. This is now the second Breakthrough Device designation granted to NucleoCapture as it was recognized previously for the treatment of sepsis.
According to FDA’s designation letter, "NucleoCapture is indicated for DNA plasma adsorption as an adjunct to standard therapy in patients with severe or life-threatening and refractory systemic lupus erythematosus, who have active disease despite current standard of care treatment."1
NucleoCapture, an extracorporeal therapeutic apheresis column designed to selectively remove cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs) from patient plasma.1 NETs are recognized as the focus of inflammation, thrombosis, autoimmunity, and multi-organ injury. Through directly targeting this pathogenic pathway, NucleoCapture displays as a non-immunosuppressive treatment option for patients suffering from life-threatening diseases that already used multiple alternative therapy options. NucleoCapture being granted a second Breakthrough Device Designation displays its potential to impact multiple therapeutic areas.
NucleoCapture’s blood purification technology is based on biocompatible, highly porous polymer beads conjugated with proprietary human recombinant histone H1.3 protein.1 Regarded as nature's ultimate DNA-binding and compacting protein, histone H1.3’s single-digit nanomolar DNA binding constants, marks it as a potent component of the innate immune defense system.1
Santersus is advancing multiple clinical development programs spanning cross a variety of treatment categories including the following.
Santersus also is preparing to initiate pivotal clinical trials in the U.S. and Europe, and supporting these milestones is the completion of Santersus’s Series A financing round, aimed at funding the advancement of NucleoCapture towards regulatory approval and commercialization.
"This second FDA Breakthrough Device Designation validates our scientific approach and highlights the urgent unmet need for safe, targeted therapies in refractory autoimmune disease," said Andrew Daniel Aswani, chief medical officer of Santersus. "We believe NucleoCapture has the potential to transform patient outcomes across a range of devastating conditions where current treatment options are limited."1
Santersus AG, a privately held therapeutic apheresis company with a medical objective aiming to revolutionize the methods of control over the human immune and inflammatory response to disease.1 Santersus focuses on developing medical devices that cleans patient blood of neutrophil extracellular traps (NETs).
NETs are fibers of decondensed DNA decorated with cytotoxic proteins that have been released from activated neutrophils1 and are recognized as one of the major driving factors in the development of the following.
Santersus reports that these indications are either currently in clinical trials or planned for future trials.
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