Neutrolis Announces Positive First-in-Human Phase 1a Results from LIBERATE-I Trial of NTR-1011, a First-in-Class DNASE1L3 Fusion Protein

• NTR-1011 demonstrated a favorable safety, tolerability, and immunogenicity profile across multiple dose levels of intravenous (IV) and subcutaneous (SC) administrations
  
• NTR-1011 displayed a predictable pharmacokinetic (PK) profile with robust SC bioavailability supporting future chronic SC dosing 
• The LIBERATE-I Phase 1b trial in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) will be initiated mid-2026
  

CAMBRIDGE, Mass., April 02, 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 positive topline results from the Phase 1a portion of its LIBERATE-I trial (NCT07237659) evaluating NTR-1011, a first-in-class DNASE1L3 fusion protein designed to dismantle pathogenic NETs and prevent their downstream proinflammatory effects that drive immune activation in autoimmune disease.

“NTR-1011 demonstrated a promising safety profile, predictable pharmacokinetics, and no immunogenicity across both intravenous and subcutaneous administration,” said Anthony Aiudi, PharmD, MBA, Chief Executive Officer of Neutrolis. “These data support the advancement of NTR-1011 into a Phase 1b study and strengthen our confidence in its ability to address the unmet needs of patients with SLE and RA.”

“NTR-1011 represents a fundamentally new approach to treating systemic autoimmune disease by directly removing the pathogenic autoantigen that drives immune activation,” said Mikael Dolsten, M.D., Ph.D., Executive Director of Neutrolis. “This approach has the potential to redefine the standard of care across chronic immune disorders with high unmet need where current therapies remain inadequate.”

Based on these results, Neutrolis plans to initiate the Phase 1b portion of LIBERATE-I, a multi-cohort basket trial in patients with moderate-to-severe SLE and RA, in mid-2026. The study is designed to generate initial patient-level data to inform dose selection and advancement into subsequent clinical development.

LIBERATE-I Phase 1a Topline Results

The recently completed Phase 1a portion was a randomized, placebo-controlled, single-ascending dose study evaluating the safety, tolerability, and pharmacokinetics of NTR-1011 administered intravenously and subcutaneously in healthy volunteers.

In the Phase 1a portion, a total of 48 healthy participants were enrolled across multiple dose cohorts. Primary endpoints included safety, tolerability, and immunogenicity. Secondary endpoints included pharmacokinetics. Exploratory endpoints included pharmacodynamic measures.

Safety and Tolerability

• NTR-1011 was well tolerated across all dose levels tested
• No serious adverse events were reported
• No dose-limiting toxicities were observed
• No clinically meaningful changes in laboratory parameters, vital signs, or electrocardiograms were observed
• No anti-drug antibodies were detected at the end of the follow-up period
  

Pharmacokinetics

• Predictable pharmacokinetics were observed following both IV and SC administration
• Subcutaneous administration demonstrated favorable exposure and bioavailability
• The pharmacokinetic profile supports development for chronic SC dosing
  

Pharmacodynamics

• Pharmacodynamic analyses demonstrated robust supraphysiologic and exposure-dependent DNASE1L3 enzymatic activity following both IV and SC administration.
  

About Neutrophil Extracellular Traps (NETs) and DNASE1L3

Neutrophil Extracellular Traps are extracellular chromatin structures released by activated neutrophils that contribute to inflammation, tissue damage, and autoantigen exposure in autoimmune disease. Impaired clearance of NETs has been implicated in the pathogenesis of numerous autoimmune and inflammatory disorders.

DNASE1L3 is a naturally occurring nuclease responsible for degrading extracellular chromatin, the structural backbone of NETs. Genetic deficiency or impaired function of DNASE1L3 has been associated with NET accumulation and early-onset autoimmune disease, supporting the rationale of DNASE1L3-based approaches as a therapeutic strategy to target this upstream driver of immune dysregulation.

About Neutrolis, Inc.

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. Unlike conventional approaches that broadly suppress immune responses, Neutrolis’s therapies harness the body’s own mechanisms to precisely degrade and inactivate NETs, offering broad potential across inflammatory disorders.

The company’s exDNASE™ platform powers the development of analogs of naturally occurring enzymes that disassemble NETs.

For more information, please visit www.neutrolis.com.

Investor Contact / Media Contact:

ir@neutrolis.com

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