Argenica Therapeutics Limited (ASX:AGN)

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Announcement

Phase 2 Trial Promising Improvements in Functional Outcomes

Release

15 Oct 2025 8:28AM

Price at Release

$0.240

Full Release

Summary

Argenica Therapeutics Limited announced promising results from its Phase 2 clinical trial of ARG-007 for acute ischaemic stroke patients. The trial aimed to evaluate the safety and functional outcomes of ARG-007, showing positive trends despite being underpowered for statistical significance. Notably, ARG-007 treated patients demonstrated improvements in cognitive performance, independence in daily living activities, and overall quality of life compared to placebo. The trial results indicated that functional outcomes, rather than infarct volume, should be the primary endpoint in future Phase 3 trials. Encouraged by these findings, Argenica plans to advance to a targeted Phase 2b trial with global partners.

Key Points

ARG-007 treated patients showed an efficacy trend over placebo in exploratory functional endpoints.
58.3% of ARG-007 patients achieved normal cognition performance by day 90.
ARG-007 improved independent daily living by 13.3% from day 30 to day 90.
ARG-007 patients showed a 6.6% improvement in disability (mRS 0-2) from day 30 to day 90.
Functional outcomes will be the primary endpoint in any registrational Phase 3 trial.
Argenica plans to design and advance a targeted Phase 2b trial.
The trial was not powered for between-group significance but showed a positive trend.
Phase 2 trial assessed safety and functional outcomes as exploratory endpoints.
ARG-007 may be preserving neuronal function and reducing secondary injury.
Argenica aims to collaborate with global partners for the next trial phase.

IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.