Invex Therapeutics approved to start Presendin phase three clinical trial in Australia

Invex Therapeutics ASX IXC approved Presendin EVOLVE phase three Australia Human Research Ethics Committee HREC Clinical Trial Notification CTN scheme Therapeutics Goods Administration TGA
Invex Therapeutics has been given the go-ahead to commence its EVOLVE clinical trial on patients with newly diagnosed idiopathic intracranial hypertension.

Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has been given the green light to start its EVOLVE phase three clinical trial in Australia on patients with idiopathic intracranial hypertension (IIH).

The company today announced it has received approval by the Human Research Ethics Committee (HREC) as well as Clinical Trial Notification (CTN) scheme clearance by Australia’s Therapeutics Goods Administration (TGA).

The trial is aimed at evaluating the efficacy and safety of Invex’s lead drug Presendin on patients with newly diagnosed IIH. The HREC approval covers a number of private hospital sites in Australia and Invex also expects to file an additional separate HREC application for a single public hospital.

No start date has been provided by the company as yet but it confirmed it remains on track to commence patient recruitment “once separate institutional authorisations are completed”.

Invex executive director and chief scientific officer Professor Alex Sinclair said the company is delighted to get the green light to commence the study.

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

IIH EVOLVE phase three trial

IIH EVOLVE is a randomised, placebo-controlled, double-blind trial aimed to determine the efficacy and safety of Invex’s lead drug Presendin, a sub-cutaneous, sustained-release Exanatide microsphere formulation.

The trial will involve 240 patients with newly diagnosed IIH being administered either Presendin or placebo once weekly for 24 weeks.

The primary endpoint of the trial is the change in intracranial pressure from the baseline, with key secondary endpoints related to vision and headache outcome measures.

Invex plans to open up to 40 clinical sites globally. Last week, the company announced it had gained regulatory approval for the trial in the United Kingdom, which was expected to start after 30 June.

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