HREC and TGA Approval for Commencement of IIH EVOLVE Phase III Clinical Trial in Australia
Key Highlights:
• Major milestone allowing patient recruitment to commence in Australia for the IIH EVOLVE Phase III clinical trial
• Private Hospital Ethics committee approval via HREC process and TGA approval both secured
• Invex targeting clinical sites (private and public) in Australia
Invex Therapeutics Ltd (Invex, ASX:IXC, or the Company) a clinical-stage biopharmaceutical company focused on the development and commercialisation of Presendin™ (sustained release Exenatide) for neurological conditions relating to raised intracranial pressure, today announces the receipt of Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA) to commence the IIH EVOLVE Phase III clinical trial in Australia, for patients with Idiopathic Intracranial Hypertension (IIH).
The HREC approval covers a number of private hospital sites in Australia that will conduct the trial, with Invex shortly to file an additional separate HREC application for a single public hospital in Australia. Invex has commenced the initiation of Australian IIH EVOLVE clinical trial sites and remains on track to commence patient recruitment once separate institutional authorisations are completed.
IIH EVOLVE is a randomised, placebo-controlled, double-blind trial that will randomise 240 patients with newly diagnosed IIH to determine the efficacy and safety of Presendin™ versus placebo,administered once weekly over 24 weeks. The primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.
Invex intends to open up to 40 clinical sites globally. Information on the trial is available at clinicaltrials.gov under Identifier NCT05347147
So next milestone would be patient recruitment. No indication of when this will commence or complete although they believe they are on track.
Held.
