Invex Therapeutics gains UK regulatory approval for clinical trial of Presendin to treat idiopathic intracranial hypertension
Invex Therapeutics expects the first IIH patient to be randomised and dosed under the EVOLVE phase three trial after 30 June.
Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has received regulatory approval to commence an EVOLVE phase three clinical trial in the United Kingdom for patients with idiopathic intracranial hypertension (IIH).
The Medicines and Healthcare Products Regulatory Agency (MHRA) approved the company’s clinical trial authorisation for lead drug Presendin.
This was followed by a favourable ethical opinion from a research ethics committee, which is a requirement prior to commencing the trial.
EVOLVE is a placebo-controlled, double-blind trial which will randomise 240 patients with newly-diagnosed IIH to determine the efficacy and safety of Presendin versus a placebo, administered once weekly over 24 weeks.
The primary endpoint 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 globally.
Important step
Invex executive director and chief scientific officer Professor Alex Sinclair said the regulatory approvals were an important step for the company’s global phase three trial initiatives.
“Newly-diagnosed IIH patients in the UK will be able to potentially participate in this trial,” she said.
“In my Birmingham clinic, I routinely observe the devastating effects of IIH on patients and their caregivers, and the associated healthcare costs to manage this disease where standard drug therapies are lacking.”
Invex’s research group has modelled the economic cost of IIH for England to be almost £500 million (A$880 million) by 2030.
In Scotland for example, the incidence of IIH has materially increased to approximately 40 cases per 100,000 in obese females aged between 15 and 44 years, and is believed to be a direct consequence of the nation’s increasing levels of obesity.
Clinical efficacy
“EVOLVE is an important and timely trial to understand the clinical efficacy and safety of our once a week treatment with Presendin in these patients,” Professor Sinclair said.
“We will be opening a number of clinical sites across the UK and will rapidly progress institutional contracts to facilitate the commencement of patient recruitment in order for the first IIH patient to be randomised and dosed after 30 June.”
Invex continues to advance its preparative activities for the EVOLVE trial including additional regulatory filings to start the study and remains confident that all approvals in Australia will be completed during the September quarter.