ImmuneWalk Therapeutics has reported positive topline results from the single ascending dose (SAD) portion of its Phase 1 POINTGUARD study evaluating IW-601, a first-in-class monoclonal antibody designed to treat immune and inflammatory diseases through a novel mechanism targeting myeloid cell migration. The data, presented at the EULAR 2025 conference in Barcelona, demonstrated safety and tolerability across all tested doses while providing mechanistic validation of the drug's unique approach.
Phase 1 Study Meets All Endpoints
The POINTGUARD study, a first-in-human, randomized, double-blind, placebo-controlled trial, evaluated subcutaneous administration of IW-601 in healthy subjects at doses ranging from 0.5mg/kg to 10mg/kg. The SAD portion successfully met all primary and secondary endpoints, with no serious adverse events reported across any dose level.
"We're very excited with the trial data and early proof of activity," said Dror Harats, M.D., Chief Executive Officer of ImmuneWalk. "The safety profile and PK curves validate the therapeutic potential of IW-601, while our initial PD data confirm the novel biology we discovered and IW-601's ability to block myeloid cells from entering inflamed tissues, which fuels inflammation."
The pharmacokinetic profile demonstrated dose-proportionality with a favorable half-life of approximately 4 weeks. Pharmacodynamic analyses revealed specific time- and dose-dependent in-vivo binding of IW-601 to myeloid cells, including monocytes and neutrophils, but not T-lymphocytes, confirming the drug's expected specificity.
Novel Mechanism Targets Adhesion Checkpoint
IW-601 represents a differentiated approach to treating inflammatory diseases by targeting MOSPD2, an adhesion checkpoint protein expressed on the surface of myeloid cells. By inhibiting MOSPD2, the antibody locks immune cells in a sticky state by activating β2-integrin, preventing their entrance into inflammatory tissues and reducing the propagation of immune responses.
"IW-601's unique mechanism of action, which inhibits monocytes and neutrophils' ability to fuel inflammation, has the potential to address key unmet needs in various immune and inflammatory diseases," Harats explained.
This mechanism offers potential advantages over traditional approaches by overcoming the redundancy of chemotaxis pathways and directly modulating tissue inflammation without depleting immune cells. The approach addresses limitations seen with current treatments that mainly target T-cells and B-cells, where many patients show resistance or experience limited, short-term benefits.
Broad Therapeutic Potential Demonstrated
Preclinical studies have demonstrated robust disease-modifying activity with IW-601 across multiple inflammatory conditions. The antibody has shown strong activity in ex-vivo patient samples and in-vivo animal models of multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease, metabolic dysfunction-associated steatohepatitis (MASH), and uveitis. The company is also exploring orphan indications, including Behçet's Disease.
Study Design and Next Steps
The POINTGUARD study enrolled healthy male and female subjects aged 18-50, with participants in the SAD portion receiving a single subcutaneous dose and being followed for 56 days to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. The study continues to enroll subjects for the multiple ascending dose (MAD) portion, where participants will receive three doses of IW-601 over 28 days at doses ranging from 1.5mg/kg to 10mg/kg.
The company expects data from the MAD cohorts later in 2025, representing one of multiple anticipated catalysts through 2025-2026.
Financial Support and Industry Recognition
ImmuneWalk recently completed a $7 million seed financing round from an institutional investor with participation from the company's management team. The funding will help accelerate IW-601's development toward additional key value inflection points beginning later in 2025.
The positive clinical data was presented through an oral presentation at the EULAR 2025 Annual Meeting, with additional presentations planned at the BIO International Convention in Boston. The recognition at these major industry conferences underscores the potential significance of ImmuneWalk's novel therapeutic approach in addressing unmet needs in immune and inflammatory diseases.
