Acasti Pharma Reports Interim Results of GTX-104 in the PK Bridging Study for the Treatment of Subarachnoid Hemorrhage
Shots:
- The (PK bridging) study evaluates GTX-104 in a ratio (1:1) in 50 patients with SAH. The results are expected in H1’22
- The trial met its EPs for Cmax on Day 1 & area under the concentration-time curve (AUC 0-24hrs.) on Day 3 & continue under the current infusion protocol to its completion. The overall objective is to evaluate the bioavailability of GTX-104 over oral nimodipine capsules & the secondary objective is to assess the safety & tolerability of GTX-104
- The P-III safety study of GTX-104 is expected to initiate in H2’21 & will finalize the study design & protocol based on final study results. GTX-104 is a novel, aqueous formulation of nimodipine developed as an IV infusion for SAH
Ref: Globe Newswire | Image: Acasti Pharma
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