Invex Therapeutics opens up more trial sites with second Australian ethics approval

Invex Therapeutics (ASX: IXC) has secured its second Human Research Ethics Committee (HREC) approval in Australia to begin its phase III trial evaluating its lead drug Presendin in patients with idiopathic intracranial hypertension (IIH).

The second HREC approval covers three additional public hospitals: the Alfred Hospital in Melbourne and Liverpool and Sydney Eye in Sydney.

Once institutional authorisations have been obtained the hospital sites will begin recruiting patients for the phase III trial which has been labelled IIH EVOVE.

Invex chief scientific officer and executive director Prof Alex Sinclair said the company now has enough Australian sites for the trial with both the private and public hospital HREC approvals, along with the greenlight from the Australian Therapeutic Goods Administration.

Leading the trial in Australia is consultant neuro-ophthalmologist at Sydney Eye, Liverpool and Macquarie hospitals Associate Prof Clare Fraser.

Dr Fraser said the trial will provide necessary clinical evidence to potentially support a new drug therapy for IIH patents, where existing treatments are lacking, and the clinical need is significant.

Prof Sinclair noted that Dr Fraser was a neuro-ophthalmologist of “high international standing”.

In addition to her consultancy with Sydney Eye, Liverpool and Macquarie hospitals, Dr Fraser consults to the Save the Site Institute, serves as vice president of The Neuro-Ophthalmology Society of Australia, is on the committee for the Neuro-Ophthalmology Virtual Education Library, and is on editorial boards for several high impact ophthalmology journals.

IIH EVOLVE trial

The IIH EVOLVE trial will recruit 240 patients with newly diagnosed IIH to determine the efficacy and safety of Presendin versus placebo.

Presendin will be administered once weekly over 24 weeks, with the trial’s primary endpoint to see a change in intracranial pressure from the original baseline.

Secondary endpoints will be to reveal improvements to vision and headache symptoms.

The trial will be run across 40 clinical sites worldwide.

Invex’s lead candidate Presendin is a repurposed version of the already approved drug Exenatide, which was previously marketed for treating type two diabetes.

IIH patients have “severely raised” intracranial pressure, which causes debilitating headaches and can compress the optic nerve.

The condition is most common in women who are obese and onset is typically from ages 20-30.

According to Invex, the addressable market for IIH in the EU, UK, and US is about $1.6 billion.