Acasti Pharma has announced positive interim data from its pivotal pharmacokinetic (PK) bridging study of GTX-104, which is being developed as an IV infusion for subarachnoid haemorrhage (SAH) patients.
The single-centre, two-period crossover, randomised PK bridging study of the new aqueous nimodipine formulation, GTX-104, is being conducted in 50 healthy participants.
The trial’s overall objective is to compare and assess GTX-104’s relative bioavailability with the oral nimodipine capsules, the current standard of care.
Safety and tolerability assessment of the drug will be the secondary objective of the bridging study.
The interim analysis of the study showed that GTX-104 met both primary endpoints for Maximum Concentration (Cmax) on the first day and Area Under the Concentration-Time Curve (AUC 0-24 hours) on the third day of the study.
Acasti Pharma noted that the achievement of both primary endpoints allows the trial to proceed under the current infusion protocol.
No serious adverse events were observed and mild adverse events such as headaches were reported in both groups during the trial.
Acasti Pharma expects to report the final study results during the first half of next year.
Acasti Pharma CEO Jan D’Alvise said: “If the final study results are consistent with these interim results, we could proceed quickly to finalise the study design and protocol for the Phase 3 Safety Study of GTX-104 with the FDA and initiate the study in the second half of 2022.
“Importantly, we believe the follow-up safety study has the potential to be relatively fast, low-cost and low-risk based on the favourable safety profile observed to date.
“Moreover, this clinical study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting our New Drug Application (NDA) to the FDA.”
SAH is bleeding that occurs in the space between the brain and the skull.