Neutrolis Doses First Patients with Systemic Lupus Erythematosus and Rheumatoid Arthritis in Phase 1b LIBERATE-I Trial of NTR-1011 and Will Present Phase 1a Data at ACR Convergence 2026
Multi-cohort Phase 1b study evaluating NTR-1011, a first-in-class DNASE1L3 fusion protein designed to degrade
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- Multi-cohort Phase 1b study evaluating NTR-1011, a first-in-class DNASE1L3 fusion protein designed to degrade Neutrophil Extracellular Traps (NETs), in patients with moderate-to-severe SLE and RA despite standard of care treatment
- Initial Phase 1b safety, biomarker and efficacy results expected in mid-2027
- Full results from completed Phase 1a in healthy volunteers will be presented at the American College of Rheumatology (ACR) Convergence 2026
CAMBRIDGE, Mass., Nov. 09, 2026 (GLOBE NEWSWIRE) — Neutrolis, Inc., a clinical-stage biotechnology company pioneering a new class of rapid-acting, non-immunosuppressive therapies targeting Neutrophil Extracellular Traps (NETs), today announced that the first patients have been dosed in the Phase 1b portion of the LIBERATE-I trial (NCT07237659). The trial is evaluating NTR-1011, a first-in-class DNASE1L3 fusion protein, in patients with moderate-to-severe systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) despite standard-of-care treatment.
Neutrolis also announced that the full results from the completed Phase 1a portion of the LIBERATE-I trial will be presented as a poster at ACR Convergence 2026, the annual meeting of the American College of Rheumatology, being held November 6–11 in Orlando, Florida.
“Remission remains out of reach for most patients with autoimmune disease, and the field continues to rely largely on broad immunosuppression,” said Anthony Aiudi, PharmD, MBA, Chief Executive Officer of Neutrolis. “Neutrophil extracellular traps, or NETs, have been implicated as a driver of multiple autoimmune diseases, and we believe that by directly targeting and degrading them, we could provide a rapid-acting, non-immunosuppressive treatment that complements currently approved medicines. With patients now being dosed in the Phase 1b portion of LIBERATE-I, we look forward to obtaining additional safety, biomarker, and preliminary efficacy data on NTR-1011. We anticipate initial study results in mid-2027.”
“The outcome we saw in an SLE patient with DNASE1L3 deficiency following administration of our therapeutic approach was remarkable, and our goal now is to learn how it translates to idiopathic SLE and RA,” said Andreas Reiff, M.D., Chief Medical Officer of Neutrolis. “The Phase 1a results established the safety, pharmacokinetic and pharmacodynamic foundation for both IV and SC administration, which enabled us to move rapidly into patients. We look forward to sharing the full healthy-volunteer results with the rheumatology community at ACR Convergence 2026 and patient data next year.
LIBERATE-I Phase 1b Design
The Phase 1b portion of LIBERATE-I is an open label multi-cohort basket trial enrolling 24 adults with moderate-to-severe disease: 12 with SLE and 12 with RA. Patients will receive five once-weekly intravenous (IV) administrations of NTR-1011, followed by a four-week follow-up period. The trial is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics, including biomarkers of NET degradation and inflammation, and to assess initial clinical activity.
The trial builds on the rapid clinical response observed with Neutrolis’ first-generation DNASE1L3 analog, NTR-441, in a patient with treatment-refractory SLE caused by DNASE1L3 deficiency, reported in The New England Journal of Medicine in July 2026, demonstrating proof of biology that supports the potential for NET degradation to improve patient outcomes.
Phase 1a Results at ACR Convergence 2026
As previously reported in April 2026, NTR-1011 was generally well tolerated across all dose levels in the randomized, placebo-controlled, single-ascending-dose Phase 1a portion of LIBERATE-I, which enrolled 48 healthy volunteers. The pharmacokinetic and pharmacodynamic profile observed following IV and subcutaneous (SC) administration supports development as a chronic IV or SC therapy. The poster will present the full safety, pharmacokinetic, pharmacodynamic and immunogenicity results.
Poster Presentation Details:
Title: First-in-Human Safety, Tolerability, Pharmacokinetics, and Immunogenicity of NTR-1011, a Recombinant DNASE1L3–Albumin Fusion Protein for Subcutaneous Delivery: Results from a Phase 1 Single Ascending Dose Study in Healthy Volunteers
Presenter: Andreas Reiff, M.D., Chief Medical Officer of Neutrolis
Abstract Number: 2204
Session: Abstract Poster Presentation
Date/Time: Tuesday, November 10, 2026, 10:30 AM – 12:30 PM ET
Location: Orange County Convention Center, Orlando, Florida
About DNASE1L3 Analogs
Neutrolis’ DNASE1L3 analogs are investigational recombinant molecules designed to restore extracellular DNASE1L3 activity and degrade NETs by dismantling their DNA backbone. Neutrolis’ portfolio includes, among others, NTR-441, used in the compassionate-use treatment described in the publication, and NTR-1011, an improved, first-in-class DNASE1L3 fusion protein.
About Neutrolis
Neutrolis is a clinical-stage biotechnology company pioneering a new class of rapid-acting, non-immunosuppressive therapies that directly target neutrophil extracellular traps (NETs), a root cause of tissue damage and chronic inflammation. NTR-1011, the company’s lead program, is currently being evaluated in a Phase 1b study in patients with moderate-to-severe systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). The company’s exDNASE™ platform powers the development of analogs of naturally occurring enzymes that disassemble NETs. For more information, visit https://neutrolis.com/.
For more information, please visit www.neutrolis.com.
Forward-Looking Statements
This press release contains forward-looking statements, including regarding the design, conduct and timing of the Phase 1b portion of the LIBERATE-I trial, the planned presentation of Phase 1a results, and the therapeutic potential of NTR-1011. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Results from healthy volunteers may not be predictive of safety or efficacy in patients. NTR-1011 is investigational and has not received marketing authorization from any regulatory authority. Neutrolis undertakes no obligation to update forward-looking statements, except as required by law.
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