ImmuneWalk Reports Promising Phase I Data for IW-601

ImmuneWalk Therapeutics has shared positive topline results from the single ascending dose (SAD) portion of its Phase I POINTGUARD trial of IW-601, presented at EULAR 2025 in Barcelona. The placebo-controlled, double-blind study tested subcutaneous IW-601 in healthy adults (18–50 years) at doses from 0.5mg/kg to 10mg/kg. The trial met all primary and secondary endpoints, showing good safety and tolerability with no serious adverse events.

Pharmacokinetics showed dose-proportional exposure and a long half-life of ~4 weeks. Pharmacodynamic data revealed dose- and time-dependent binding to myeloid cells, but not T-lymphocytes, and a significant reduction in monocyte migration.

Participants received a single dose and were monitored for 56 days. The ongoing multiple ascending dose (MAD) phase includes three doses over 28 days (1.5–10mg/kg), with results expected later this year. IW-601 targets MOSPD2 on myeloid cells.

18-06-2025