Biopharmaceutical company Invex Therapeutics (ASX: IXC) has announced the opening of clinical sites in Australia and the UK, allowing patient screening and recruitment to commence immediately for its Evolve phase III trial of lead drug Presendin to treat neurological conditions relating to raised intracranial pressure.
The Australian site is located at the Adelaide offices of eye specialist VisionSA and will recruit part of the total 240 individuals required for the global multi-centre trial, which aims to determine the efficacy and safety of Presendin versus placebo, over a six-month period.
The primary endpoint of the trial is a change in intracranial pressure from baseline, with key secondary endpoints related to vision and headache outcome measures.
Invex intends to open up to 40 clinical sites worldwide.
Important milestone
Executive director Dr Tom Duthy said he was pleased to open an Australian site.
“Our first Australian clinical site for patient recruitment represents the culmination of a significant level of preparative activity to reach this important milestone,” he said.
“We appreciate the commitment of Associate Professor Celia Chen to the trial as a principal investigator for our study in Australia, alongside her role as a director at VisionSA and a consultant ophthalmologist at Flinders Medical Centre in Adelaide.”
UK clinical site
The new UK clinical site is located at University Hospital in Birmingham and will be led by consultant neuro-ophthalmologist Professor Susan Mollan.
“This is the first major clinical trial into idiopathic intracranial hypertension (IIH) which is seeking regulatory approval for a new therapeutic agent and if successful, would represent a major shift in the current treatment paradigm,” she said.
“With an acceleration of IIH incidence rates in the UK and a rise in the related economic cost of managing patients, I am pleased to be involved in this important clinical trial where a first-line, standard drug therapy intervention is desperately needed.”
Valuable member
Invex executive director Professor Alex Sinclair said Professor Mollan would be a valuable addition to the trial.
“Professor Mollan is considered to be one of the leading clinicians and researchers in the field of IIH globally, having authored a number of peer-reviewed publications in the field and co-authored the current consensus treatment guidelines for IIH used across the globe,” she said.
“We are very pleased she has joined the IIH Evolve trial as an investigator and steering committee member.”
