Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has confirmed it will proceed with a phase III clinical trial to achieve global registration of lead drug Presendin in the treatment of idiopathic intracranial hypertension (IIH).
The IIH Evolve trial will specifically focus on meeting the requirements for market approval in the European Union, the UK and Australia utilising a design based on advice received from the European Medicines Agency.
Data collected is expected to further inform a subsequent development of Presendin for the US market.
The Evolve trial will recruit 240 patients across 37 centres in Europe, the UK, Australia and the US who will be randomised to receive either subcutaneous injections of Presendin or a placebo, administered once a week over 24 weeks.
The primary endpoint will assess the mean difference in intracranial pressure from baseline to 24 weeks between patients receiving Presendin and those on placebo.
Secondary endpoints will assess the relative difference in vision (known as perimetric mean deviation and papilloedema) and monthly headache days (MHD) between the two groups over 24 weeks.
Trial costs will be funded from Invex’s existing cash reserves of $32 million and recruitment is anticipated to take approximately 24 months.
Invex said it would appoint a lead investigator and execute agreements with key service providers before year-end.
The first clinical trial application will be submitted at the same time, incorporating non-clinical and clinical information for Presendin under the terms of a recent collaboration and manufacturing deal with Korean company Peptron Inc.
Invex chairman Dr Jason Loveridge said the trial would be a “clear, low-risk approach” to bringing Presendin to market as quickly as possible.
IIH features severely raised intracranial pressure which causes disabling daily headaches and can compress the optic nerve.
Patients typically experience first onset before 30 years of age, and the condition is most common in women who are obese.
The incidence of IIH has increased by more than 350% in the last 10 years.