ImmuneWalk Therapeutics has presented positive topline data from the single ascending dose (SAD) part of the randomised, first-in-human Phase I POINTGUARD trial of subcutaneously administered immunology and inflammation drug, IW-601.
The data was presented by the company at the European Alliance of Associations for Rheumatology (EULAR) 2025 conference in Barcelona, Spain.
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The placebo-controlled, double-blind, dose-ranging study assessed IW-601 across a range of doses from 0.5mg/kg to 10mg/kg in healthy participants, meeting all primary and secondary goals. It involved males and females aged 18-50.
It demonstrated tolerability and safety across all doses, without any serious adverse events identified.
The pharmacokinetic (PK) profile indicated dose-proportionality and a long half-life of approximately four weeks, while pharmacodynamic (PD) analyses revealed certain time- and dose-dependent in vivo attachment of the therapy to myeloid cells, but not T-lymphocytes.
Moreover, those treated with IW-601 exhibited a significant decrease in monocyte migration.
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By GlobalDataParticipants in the SAD part received a single dose of IW-601 and were followed for 56 days to evaluate the therapy’s tolerability, safety, PD, and PK.
ImmuneWalk Therapeutics CEO Dror Harats said: “We’re very excited with the trial data and early proof of activity.
“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.”
In the multiple ascending dose (MAD) portion, the participants will be given three doses of the therapy over 28 days at doses from 1.5mg/kg to 10mg/kg.
The trial is actively enrolling participants for the MAD part, and the data from these cohorts is anticipated by the company later this year.
IW-601 is a monoclonal antibody that targets MOSPD2, which is expressed on the surface of myeloid cells.
