- Invex Therapeutics (IXC) Receives Therapeutic Goods Administration (TGA) Human Research Ethics Board Approval to Begin Its EVOLVE Phase 3 Clinical Trial
- TGA also approves clearance of company’s clinical trial notification program and seen as ‘major milestone’ to begin patient recruitment
- The trial will focus on patients with newly diagnosed idiopathic intracranial hypertension to determine the safety and efficacy of Presendin versus placebo
- The company intends to open up to 40 clinical sites worldwide
- Invex shares end the day 2.06% in the green to close at 49.5 cents
Invex Therapeutics (IXC) has received Human Research Ethics Committee (HREC) approval and Clinical Trial Notification Program clearance from the Therapeutic Goods Administration (TGA) to commence its Phase 3 clinical trial EVOLVE in Australia.
This is seen as a ‘major milestone’ which will allow patient recruitment to begin in Australia for the clinical trial.
The clinical trial is enrolling 240 patients with newly diagnosed idiopathic intracranial hypertension (IIH) to determine the efficacy and safety of Presendin compared to placebo,
administered once a week for 24 weeks.
The HREC approval covers a number of private hospital sites in Australia that will conduct the trial, with the company soon to file a separate supplemental HREC application for a single public hospital in Australia.
Executive Director and Scientific Director Professor Alexandra Sinclair said the company was delighted to receive approvals for this “groundbreaking” study.
“We believe that the lack of approved therapies for IIH and the associated unmet medical needs in this study population bodes well for strong clinical support, effective patient recruitment and execution of this controlled clinical trial. high-quality randomized study,” Professor Sinclair said.
Principal Investigator for IIH EVOLVE in Australia, Associate Professor Celia Chen reiterated Professor Sinclair and called the trial important.
“As a practicing clinician who observes the significant impacts on the quality of life of patients with IIH, the goal of developing safe and effective treatments for these patients through a large randomized clinical trial like IIH EVOLVE is to of paramount importance,” she said.
The primary endpoint of the trial is change in intracranial pressure from baseline, with key secondary endpoints relating to outcome measures of vision and headache.
The company intends to open up to 40 clinical sites worldwide.
Shares of Invex ended the day 2.06% in the green to close at 49.5 cents.