Invex Therapeutics opens first US clinical site for Presendin trials
According to Invex, there are currently no approved treatments for idiopathic intracranial hypertension.
Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has announced the opening of its first US-based clinical site at the Eye Wellness Centre in Texas.
The centre is run by respected neuro-ophthalmologist Dr Rose Tang and will be integral to trials of the company’s lead candidate Presendin (sustained-release Exenatide) for neurological conditions relating to raised intracranial pressure.
Dr Tang has been a principal investigator on previous idiopathic intracranial hypertension (IIH) trials in the US.
Invex expects to open a total of 10 clinical sites in the US and up to 40 worldwide, which will contribute participants to Presendin’s IIH Evolve phase III trial.
Randomised trial
Evolve phase III is a placebo-controlled, double-blind study which will randomise 240 patients with newly-diagnosed IIH to determine the efficacy and safety of Presendin versus placebo, administered once per week 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.
In August, Invex received an investigational new drug application approval from the US Food and Drug Administration (FDA) for Presendin and for the start of the phase III trial in the US for patients with IIH.
Paediatric plan
Last month, a paediatric investigation plan submitted by Invex to trial Presendin in adolescents was accepted by the European Medicines Agency.
The approval will allow Invex to develop a trial involving up to 40 male and female IIH patients who are under 18 years of age and have reached puberty.
The primary endpoint will be determined by a change in papilloedema (swelling of the optic disc) assessed by optical coherence tomography over the course of the trial.
Key secondary endpoints will include perimetric mean deviation, headache evaluation and visual acuity at 24 weeks, along with safety assessments and concomitant medication use throughout the study.
Intracranial pressure
IIH features severely elevated intracranial pressure which causes disabling daily headaches and can compress the optic nerve.
The pressure is caused by alterations in the volume of either cerebral blood, cerebrospinal fluid or brain tissue.
The usual age of onset is around 30 years and the condition is most common in women who are obese.
IIH is a rapidly-growing orphan indication, with an incidence that has increased by more than 350% in the last 10 years.