- Invex Therapeutics (IXC) activates its first US site for clinical trials to treat intracranial pressure
- The new site is located within the Eye Wellness Centre in Bellaire, Texas and will be used for Invex’s idiopathic intracranial hypertension EVOLVE Phase III clinical trial
- The site will be directed by Dr Rosa Tang, a neuro-ophthalmologist who was previously a principal investigator on similar trials in the US
- The company says it anticipates opening 10 clinical sites in the US, along with a further 30 sites globally
- Invex Therapeutics last traded at 57 cents at 2:30 pm AEDT
Invex Therapeutics (IXC) has activated its first US clinical site for clinical trials to treat intracranial pressure.
The new site is located at the Eye Wellness Centre in Bellaire, Texas.
The company first received US Food and Drug Administration (FDA) investigational new drug application (IND) approval for Presendin, and, to start the idiopathic intracranial hypertension (IIH) EVOLVE Phase III clinical trial in the US, in August 2022.
IIH EVOLVE is a randomised, placebo-controlled, double-blind trial that will see 240 patients with newly diagnosed idiopathic intracranial hypertension (IIH) dosed with Presendin to determine its efficacy and safety, versus a placebo.
With the FDA approval in hand, treatment has the green light to begin. This will involve weekly administrations over 24 weeks to measure the change in intracranial pressure from baseline.
The new site will be fronted by Dr Rosa Tang, a neuro-ophthalmologist and Co-Medical Director of The Eye Wellness Centre, Neuro-ophthalmology of Texas, and Neuro Eye Clinical Trials Inc.
Dr Tang previously worked as a principal investigator on past IIH Trials in the US. Invex’s Executive Director and Chief Scientific Officer, Professor Alex Sinclair, thanked Dr Tang and her team at the Eye Wellness Center for their participation in the trial.
“We anticipate opening 10 clinical sites in the US and this market is expected to be an important contributor of patients into the company’s IIH EVOLVE Phase III clinical trial,” Alex Sinclair told investors.
The company said it intends to open 40 sites globally for the trial.
Invex Therapeutics last traded at 57 cents at 2:30 pm AEDT.