- Study met primary endpoint of safety and tolerability at all doses and secondary pharmacodynamic and pharmacokinetic endpoints after single subcutaneous administration
- Pharmacodynamics provides mechanistic validation, demonstrating dose-dependent binding of IW-601 to myeloid cells (monocytes and neutrophils), inhibition of cell migration, and dose-proportional pharmacokinetics with a half-life of ~ 4 weeks
- Data presented in an oral presentation at EULAR 2025 conference
NEW YORK and PETACH TIKVAH, Israel, June 11, 2025 (GLOBE NEWSWIRE) -- ImmuneWalk Therapeutics, a clinical stage company focused on modulating immune and inflammatory disease by preventing myeloid cells (monocytes and neutrophils) from entering inflamed tissues, today announced the presentation of positive topline data from the single ascending dose (SAD) portion of the Phase 1 POINTGUARD study evaluating subcutaneously administered IW-601 at the EULAR 2025 conference in Barcelona. The dose-ranging study met all of its endpoints, showing safety and tolerability at all doses, a favorable pharmacokinetic (PK) profile and positive pharmacodynamic (PD) readouts.
“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 study continues to enroll subjects for the multiple ascending dose part and we expect data from these cohorts later in 2025.”
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. The SAD portion of the study met all of its primary and secondary endpoints. Safety and tolerability were demonstrated at all doses with no serious adverse events reported. The PK profile shows dose-proportionality and a long half-life of ~4 weeks. PD analyses show specific time- and dose-dependent in-vivo binding of IW-601 to myeloid cells (monocytes and neutrophils), but not T-lymphocytes, coinciding with IW-601’s expected specificity. IW-601 treated subjects showed a significant reduction in monocyte migration, further validating IW-601’s novel mechanism of action.
About The POINTGUARD Study
The POINTGUARD Study is 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 were followed for 56 days to assess the safety, tolerability, PK and PD of IW-601. In the MAD part, subjects will receive 3 doses of IW-601 over 28 days at doses ranging from 1.5mg/kg to 10mg/kg.
About IW-601
IW-601 is a monoclonal antibody targeting MOSPD2, an adhesion checkpoint expressed on the surface of myeloid cells, and more specifically on monocytes and neutrophils. Inhibition of MOSPD2 locks these immune cells in a sticky state by activating 2-integrin, 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 without depleting immune cells. 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) and uveitis. Orphan indications, such as Behçet's Disease, are also being explored.
About ImmuneWalk Therapeutics
ImmuneWalk Therapeutics is a clinical-stage biotechnology company dedicated to developing novel therapies for immune-inflammatory 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 has discovered a new adhesion checkpoint that selectively regulates the migration of myeloid cells into inflamed tissues and has the ability to overcome these limitations. Their lead candidate, 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, and metabolic dysfunction-associated steatohepatitis. The company is currently conducting the POINTGUARD Phase 1 clinical trial, with the Single Ascending Dose stage successfully completed and multiple catalysts anticipated in 2025-2026. For more information, visit www.immunewalk.com
Investor and Media Inquiries
Sam Backenroth
info@immunewalk.com
