ImmuneWalk Therapeutics Announces Positive Results from Phase 1 SAD/MAD Study of IW-601, a First-In-Class Therapeutic with Broad Potential in Inflammatory and Autoimmune Diseases

• Phase 1 Clinical Trial Met All Primary and Secondary Endpoints and Demonstrated Positive Safety, Pharmacokinetics, and Mechanistic Validation
• Clinical Data Build Upon Robust Preclinical Activity Seen in Multiple Models of Inflammatory Disease
• Novel Approach Addresses Inflammation Driven by Monocytes and Neutrophils, Key Drivers in Many Auto-Inflammatory and Auto-Immune Diseases
• Phase 2 Study in Behçet's Disease, an Orphan Inflammatory Indication Selected for Initial Proof-Of-Concept, to Start in Q2 2026, Followed by Phase 2b Study in Highly Prevalent I&I Disease in 1H 2027

NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- ImmuneWalk Therapeutics, a company dedicated to pioneering innovative approaches to addressing unmet needs in Immunology and Inflammation (I&I) diseases, today announced positive results from the POINTGUARD study evaluating subcutaneously administered IW-601, a highly selective biologic inhibitor of myeloid cell (monocyte and neutrophil) tissue infiltration. The study met all primary and secondary endpoints, demonstrating safety and tolerability of IW-601 at all doses, an excellent pharmacokinetic (PK) profile, and positive mechanistic readouts.

"The IW-601 results from the POINTGUARD study have demonstrated an excellent target product profile with applicability for both orphan and highly prevalent I&I indications,” said Dror Harats, MD, Chief Executive Officer of ImmuneWalk Therapeutics. "These results validate our novel approach to addressing inflammation driven by monocytes and neutrophils, which plays a central role in many auto-inflammatory and auto-immune diseases. We are rapidly preparing to initiate a Phase 2 study in Behçet's disease, a neutrophil-driven rare inflammatory disorder selected as the initial proof-of-concept indication, in the second quarter or 2026, to be followed by a trial in a highly prevalent I&I disease in the first half of 2027."

IW-601’s novel mechanism of action represents a breakthrough in myeloid cell trafficking and tissue infiltration. The drug targets MOSPD2, a cell surface protein expressed specifically on myeloid cells. Inhibition of MOSPD2 keeps β2-integrin in a high affinity adherent state on these immune cells only, blocking the pathologic tissue infiltration that drives chronic inflammation, while preserving systemic immune function. This approach offers potential therapeutic advantages in a broad spectrum of inflammatory and autoimmune diseases characterized by aberrant monocyte and neutrophil infiltration.

POINTGUARD is a first-in-human Phase 1, randomized, double-blind, placebo-controlled, dose-ranging study evaluating subcutaneous administration of IW-601 in healthy subjects at doses ranging from 0.5mg/kg to 10mg/kg. Four single ascending dose (SAD) cohorts and three multiple ascending dose (MAD) cohorts were enrolled (N=6 treated, 2 placebo per cohort). The SAD and MAD portions of the study met all primary and secondary endpoints. Safety and tolerability were demonstrated at all doses with no serious adverse events or dose-limiting toxicities observed. Importantly, there were no clinically relevant changes in safety parameters and clinical laboratory tests, including CBC, chemistry, coagulation, immunophenotyping and urinalysis. The only drug-related AEs observed were mild and transient self-resolving injection site reactions.

The PK profile showed dose-proportional increases in plasma concentrations across all cohorts with a long half-life of ~4 weeks, suggesting the potential for monthly subcutaneous dosing after an initial dose loading phase. The achieved blood concentrations, Cmax and exposure, are 3-6 fold higher than the levels required for >85% inhibition of myeloid cell migration ex-vivo, as demonstrated in assays using blood samples from patients with relapsing/remitting and progressive multiple sclerosis, Crohn’s, ulcerative colitis, arthritis, psoriatic arthritis, Behçet's disease and familial Mediterranean fever. Target engagement was further confirmed by specific time- and dose-dependent binding of IW-601 to myeloid cells (monocytes and neutrophils), but not T-lymphocytes, confirming its expected specificity based on its mechanism of action. The company plans to present the results at a scientific meeting in 2026.

About The POINTGUARD Study 

The POINTGUARD study was a Phase 1, first-in human, prospective, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy male and female subjects aged 18-50. Subjects in the SAD portion received a single dose of subcutaneously administered IW-601 at doses ranging from 0.5mg/kg to 10mg/kg, and in the MAD part, subjects received 3 doses of IW-601 over 28 days at doses ranging from 1.5mg/kg to 10mg/kg. All subjects were followed for 56 days to assess the safety, tolerability, PK and PD of IW-601.

About IW-601 

IW-601 is a monoclonal antibody targeting MOSPD2, a protein expressed on the surface of myeloid cells, and more specifically on monocytes and neutrophils. The MOSPD2 pathway represents a breakthrough in understanding myeloid cell trafficking and tissue infiltration. Inhibition of MOSPD2 locks these immune cells in a sticky state by keeping 2-integrin in an active adhesive state, thereby preventing their entrance into inflammatory tissues and reducing the propagation of immune responses. IW-601’s novel mechanism offers potential advantages over traditional approaches by overcoming the redundancy of chemotaxis pathways and directly modulating tissue inflammation while preserving systemic immune function. This distinction offers potential therapeutic advantages in a broad spectrum of inflammatory and autoimmune diseases characterized by aberrant monocyte and neutrophil infiltration. Robust disease modifying preclinical activity has been demonstrated with IW-601 in ex-vivo patient samples and in-vivo animal models of multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, metabolic dysfunction-associated steatohepatitis (MASH), uveitis and Behçet's disease.

About ImmuneWalk Therapeutics

​ImmuneWalk Therapeutics is a clinical-stage biotechnology company dedicated to pioneering innovative approaches to addressing unmet needs in Immunology and Inflammation (I&I) diseases. While current treatments for immune and inflammatory conditions mainly target T-cells and B-cells, many patients either show resistance or experience limited, short-term benefits using these approaches. ImmuneWalk Therapeutics has developed IW-601, a novel therapeutic targeting MOSPD2 (Motile Sperm Domain-Containing Protein 2), a recently characterized target expressed on the surface of myeloid cells, specifically monocytes and neutrophils. IW-601 is a proprietary monoclonal antibody engineered to specifically prevent monocytes and neutrophils from entering inflammatory tissues. This innovative mechanism offers a differentiated approach compared to existing anti-inflammatory and immune modulating agents. IW-601 has demonstrated disease-modifying activity in preclinical models of multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, metabolic dysfunction-associated steatohepatitis, uveitis, and Behcet’s. The company is planning to start a Phase 2 study in Bechet’s disease in Q2 2026 as an initial proof-of-concept indication, and a Phase 2b study in a highly prevalent I&I disease in 1H 2027. For more information, visit www.immunewalk.com

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info@immunewalk.com

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