Professor Alexandra Sinclair (far right) with attendees of the IIH UK Patient Conference. Source: Invex Therapeutics
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  • Invex Therapeutics (IXC) receives Human Research Ethics Committee approval by the Therapeutic Goods Administration (TGA) to commence its EVOLVE Phase 3 clinical trial
  • The TGA also approves the company’s clinical trial notification scheme clearance and is considered a “major milestone” which will allow patient recruitment to begin
  • 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 globallyThe primary endpoint of the trial is the change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures
  • Shares in Invex end the day 2.06 per cent in the green to close at 49.5 cents

Invex Therapeutics (IXC) has received Human Research Ethics Committee (HREC) approval and clinical trial notification scheme clearance by the Therapeutic Goods Administration (TGA) to commence its EVOLVE Phase 3 clinical trial in Australia.

This is considered a “major milestone” which will allow patient recruitment to commence in Australia for the clinical trial.

The clinical trial focuses on 240 patients with newly diagnosed idiopathic intracranial hypertension (IIH) to determine the efficacy and safety of Presendin versus placebo,
administered once weekly over 24 weeks.

The HREC approval covers a number of private hospital sites in Australia that will conduct the trial, with the company shortly to file an additional separate HREC application for a single public hospital in Australia.

Executive Director and Chief Scientific Officer Professor Alexandra Sinclair said the company is delighted at receiving the approvals for the “ground-breaking” study.

“We believe the lack of approved therapies for IIH and the associated unmet medical need in this study population augurs well for strong clinician support, efficient patient enrolment and execution of this high quality randomised controlled clinical trial,” Professor Sinclair said.

Principal Investigator for IIH EVOLVE in Australia Associate Professor Celia Chen reiterated Professor Sinclair and called the trial important.

“As a practising clinician who observes the significant quality of life impacts on patients suffering from IIH, the goal of developing safe and effective treatments for these patients by way of a large randomised clinical trial like IIH EVOLVE is of paramount importance,” she stated.

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.

The company intends to open up to 40 clinical sites globally.

Shares in Invex have ended the day 2.06 per cent in the green to close at 49.5 cents.

IXC by the numbers
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