NucleoCapture Gets FDA Breakthrough Designation for Systemic Lupus Erythematosus

Santerus AG has received Breakthrough Device Designation from the United States (US) Food and Drug Administration for its NucleoCapture blood purification technology for the treatment of severe, treatment-refractory systemic lupus erythematosus (SLE).1

"This second FDA Breakthrough Device Designation validates our scientific approach and highlights the urgent unmet need for safe, targeted therapies in refractory autoimmune disease," Andrew Daniel Aswani, PhD, Chief Medical Officer of Santersus, said in a statement.1 "We believe NucleoCapture has the potential to transform patient outcomes across a range of devastating conditions where current treatment options are limited."

NucleoCapture is an extracorporeal therapeutic apheresis column designed to selectively remove cell-free DNA (cfDNA) and neutrophil extracellular traps (NETs) from patient plasma. NETs are increasingly recognized as key drivers of inflammation, thrombosis, autoimmunity, and multi-organ injury. NucleoCapture may offer a novel, non-immunosuppressive treatment option for patients with a variety of diseases that have been refractory to current standard-of-care therapies. For people with active SLE, NucleoCapture is being investigated as an adjunct to standard therapy.

Santerus AG previously received Breakthrough Device Designation for NucleoCapture for the treatment of sepsis. In addition to sepsis and septic shock, the company is also investigating the device for the prevention of graft injury and dysfunction and neurodegeneration, including Alzheimer disease and other neurodegenerative disorders. Santersus is preparing to initiate pivotal clinical trials in both the U.S. and Europe for all potential indications.

The latest advances in lupus research were presented at July’s European Alliance of Associations for Rheumatology (EULAR) Congress 2025 held in Barcelona, Spain. One high impact trial presented there was the phase 3 PHOENYCS GO trial which is evaluating dapirolizumab pegol (DZP) in people with moderate-to-severe SLE, positive data from which were presented by Eric F. Morand, MBBS, Head of the Monash Health Rheumatology Unit, Monash University, Australia.2

“[PHOENYCS GO] is a positive phase 3 trial - evidence does not get much better than this. Trials in SLE are really hard to do, as the disease is heterogenous and endpoints disfavor success - this means a positive result has basically happened against the odds and is meaningful,” Morand told HCPLive. “How DZP fits into the treatment paradigm remains to be seen as the pipeline has lots of other interesting medicines in development which together will change the landscape very greatly in the next handful of years. Regardless, these data strongly suggest that CD40L has a real place in our care paradigm.”

Morand and colleagues found that at Week 48, 40.9% of participants receiving DZP plus standard of care (SOC) achieved low disease activity, more than double the rate in the SOC-only group (19.6%; nominal* P <.0001). As early as Week 12, significantly more participants on DZP plus SOC achieved low lupus disease activity state (LLDAS) versus SOC alone (nominal* P <.05). Additionally, 23.6% of the DZP group maintained low disease activity in ≥50% of visits over 48 weeks, compared to 15.9% with SOC alone (nominal* P = .1042). At Week 48, 19.2% of participants receiving DZP achieved remission (DORIS criteria), compared to 8.4% in the SOC-only group (nominal* P = .0056).

“As we get used to the patient profiles that may respond differently to differently targeted medicines, or differences in safety profile that may influence our choice based on patients’ comorbidities, things will get clearer. On the basis that DZP clearly increases attainment of treatment goals, it will have a significant role if it gains regulatory approval,” Morand said.

References

1. Santersus AG Receives Second US FDA Breakthrough Device Designation for NucleoCapture in Systemic Lupus Erythematosus. News release. Santerus AG. August 26, 2025. https://finance.yahoo.com/news/santersus-ag-receives-second-us-193500630.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAFFl8bRntQ7jzDSpQT2yEMwphCwzqvrvZs241SXjVkD_ec9ZU_lCcuz_YDwbH85DGqLdJQBRTBgZCRaVDXVuOK-e5ujLsGyvF2AfIK4wk6SG9WiJ4q2x8B5jCAb5kkzdCfux7HQ1QnYz3-WRthhflUqBD1575ABdC2Qmzxetg15i

2. Dapirolizumab Pegol Phase 3 Data in SLE Presented at the Annual European Congress of Rheumatology (EULAR) Show Improvement in Fatigue and Reduction in Disease Activity. Biogen. News release. June 12, 2025. https://investors.biogen.com/news-releases/news-release-details/dapirolizumab-pegol-phase-3-data-sle-presented-annual-european