- Invex Therapeutics (IXC) Obtains Approval to Start Presendin Phase III Trial in the UK, Treating Patients with Idiopathic Intracranial Hypertension (IIH)
- A total of 240 newly diagnosed IIH patients will receive either Presendin or placebo once a week for 24 weeks in a double-blind trial
- Patients with IIH suffer from elevated intracranial pressure, causing disabling daily headaches and, in some cases, a compressed optic nerve
- The first patient is expected to receive a dose after June 30
- IXC ends the day 4.49% in the green with shares trading at 46.5 cents
Invex Therapeutics (IXC) has received approval in the UK to start its Phase III trial of using Presendin to treat patients with idiopathic intracranial hypertension (IIH).
Invex has received Clinical Trial Authorization (CTA) from the Medicines and Healthcare Products Regulatory Agency (MHRA) for the IIH EVOLVE trial, which will see 240 newly diagnosed IIH patients receive either Presendin or a placebo once per week for a 24-week double-blind trial.
Patients with IIH suffer from severely elevated intracranial pressure that causes disabling daily headaches and can compress the optic nerve. It is more common in obese women and is a rapidly increasing disease – increasing by more than 350% in the last 10 years.
The trial will test the efficacy and safety of the drug and aims to alter intracranial pressure in patients, with the side outcome of improved vision and headaches.
The company says that in addition to approval, it has also received a “favorable ethical opinion from a research ethics board” – a requirement before the trial can begin.
Professor Alex Sinclair, Executive Director and Chief Scientific Officer of Invex, said the approval, together with the favorable opinion, marks a “significant milestone” for their phase three trial efforts across the world.
“At my clinic in Birmingham, I regularly observe the devastating effects of IIH on patients, their carers, and the associated healthcare costs of managing their disease, where standard drug therapies fail,” he said. declared.
“Our research group has modeled the economic cost of IIH to England at almost £500 million by 2030.
“In Scotland, for example, the incidence of IIH has also increased significantly to around 40 per 100,000 in obese women aged 15-44, which is a direct consequence of rising levels obesity.”
The company is working on the next steps to set up the trial, with the first patient to receive a dose after June 30.
Invex says this approval now allows the company to “better harmonize” the trial with other regulatory agencies. The company “remains confident” that it will be approved in Australia during the September quarter.
IXC ended the day 4.49% in the green with shares trading at 46.5 cents.