Biotech

Invex Therapeutics to begin patient recruitment for phase III Presendin trial in IIH

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By Lorna Nicholas - 
Invex Therapeutics ASX IXC patient recruitment phase III Presendin trial IIH Idiopathic Intracranial Hypertension

Invex will recruit newly diagnosed IIH patients into the phase III trial during the second half of this year.

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Invex Therapeutics (ASX: IXC) will begin a phase III clinical trial of its drug Presendin after locking-in approval along with investigational new drug (IND) status from the United States Food and Drug Administration.

The IIH EVOLVE phase III trial will be undertaken in the US and evaluate Presendin in patients with idiopathic intracranial hypertension (IIH).

A number of clinical sites will be opened across the US to support the trial.

Invex will begin recruiting first patients into the phase III trial during the second half of this year once Invex has secured the necessary contracts and human ethics committee approvals.

IIH EVOLVE phase III trial steering group chairperson Prof Michael Wall said the “high calibre” randomised controlled clinical trial will answer many important questions.

Invex chairperson Dr Jason Loveridge said the outcomes of this phase III trial have the potential to “transform the lives of thousands of IIH patients”.

Dr Loveridge noted there were no existing regulatory approved drug therapies for treating IIH. As a result, many IIH patients see their disease progress to a stage where invasive neurosurgical and ophthalmic surgeries are required to alleviate severe headaches and prevent permanent blindness.

IIH EVOLVE trial

In addition to the US patient recruitment, the trial will also enrol IIH sufferers in the UK, Australia, Europe, New Zealand and Israel.

All-up 240 patients with newly diagnosed IIH will be enrolled in the trial across 40 clinical sites. Patients will either be given Presendin or a placebo once a week over 24 weeks.

The IIH EVOLVE phase III study has been designed to meet regulatory requirements to secure market approval for Presendin in treating IIH in Australia, the UK and EU.

IIH and Presendin

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

It usually comes on between the ages of 20 and 30 and is most common in women who are obese.

The incidence of IIH has risen more than 350% in the last decade.

Invex estimates the annual addressable market for IIH in the EU, UK and US is around $1.6 billion.

Previously marketed as Exenatide for type two diabetes, Invex has repurposed Presendin for treating IIH.