- Invex Therapeutics (IXC) gains approval to start its IIH EVOLVE phase III clinical trial in Germany to treat patients with idiopathic intracranial hypertension (IIH) using Presendin
- The approval was received from Germany’s Federal Institute for Drugs and Medical Devices and marks another step towards the commercialisation of Presendin
- The trial will test 240 patients with newly-diagnosed IIH to assess the efficacy and safety of Presending versus a placebo
- Invex entered an exclusive collaboration, manufacturing and supply agreement back in September 2021 with Peptron for Presendin in IIH for all major markets except for South Korea
- IXC shares are up 2.22 per cent to 46 cents at 10:46 am AEDT
Invex Therapeutics (IXC) has achieved another key milestone in its efforts to commercialise its Presendin drug to treat neurological conditions related to raised intracranial pressure.
On Monday, the Perth-based clinical-stage biopharmaceutical company announced it had received approval to start its IIH EVOLVE phase three clinical trial in Germany for patients with idiopathic intracranial hypertension (IIH).
The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany’s Federal Institute for Drugs and Medical Devices, handed Invenx the green light for the trial.
“This approval from the BfArM German competent authority represents our first national regulatory clearance in Europe for our study,” Invex Executive Director and Chief Scientific Officer Alex Sinclair said.
“We are now completing the necessary institutional agreements for our intended clinical sites.”
Professor Sinclair added that entry into Germany’s market could help facilitate the company’s plans to gain European Medicines Agency (EMA) approval for Presendin.
The IIH Evolve trial is a random, placebo-controlled, double-blind study to test 240 patients with newly-diagnosed IIH to assess the efficacy and safety of Presendin versus placebo, dosed once weekly over the course of a 24-week testing period.
The primary goal of the trial is to adjust the intracranial pressure from baseline, as well as mitigate vision and headache symptoms.
Invex remains focused on the commercialisation of Presendin, with the aim of opening up to 40 clinical sites globally.
What is idiopathic intracranial hypertension (IIH)
“Idiopathic” refers to the cause not being known, while “intracranial” refers to the skull and “hypertension” means high pressure.
IIH causes daily headaches and puts extra pressure on your brain and the optic nerve.
It occurs when there is a build-up of cerebrospinal fluid (CSF) — meaning there is too much fluid around the brain and spinal cord.
Typically, the usual age of onset is 20-30 years old, but IIH is more common in women who are obese.
According to Expert Market Research (EMR), the rising demand for IIH has been caused by an increasing number of obese people and an ageing population.
IIH is believed to affect about one in every 100,000 people.
EMR believes the demand for IIH cures is likely to grow further across the globe, especially in North America, with the region’s advanced healthcare technology.
However, generally high treatment costs and poor reimbursement policies could impact market growth.
Despite this, the market is anticipated to grow at a compound annual growth rate (CAGR) of 4.27 per cent during the forecasted period of 2023-2031.
IXC shares were up 2.22 per cent to 46 cents at 10:46 am AEDT.