Join our daily newsletter At The Bell to receive exclusive market insights
- Invex Therapeutics (IXC) is set to launch a phase three clinical trial of its drug Presendin in Europe, the UK and Australia
- Around 240 patients suffering Idiopathic Intracranial Hypertension (IIH) will receive either a weekly injection of Presendin or a placebo to assess the difference in intracranial pressure (ICP)
- Pending the outcome of the trial, further discussions with the US FDA will take place regarding registration of Presendin in the United States
- Invex says it aims to have the first clinical trial application filed in the fourth quarter of 2021, and is fully funded from existing cash reserves of $32 million
- Invex Therapeutics was up 14.5 per cent, trading at 75 cents per share as of 10:40 am AEDT
Invex Therapeutics (IXC) is set to launch a phase three clinical trial of its drug Presendin in Europe, the UK and Australia.
Presendin is a weekly, sub-cutaneous formulation, which Invex is using to treat Idiopathic Intracranial Hypertension (IIH). Presendin is a repurposed form of already-approved drug Exenatide, which has been proven to treat neurological conditions involving intracranial pressure.
Patients with IIH suffer from severely raised intracranial pressure which causes disabling daily headaches and can compress the optic nerve.
Around 240 IIH patients will receive either once-a-week sub-cutaneous injections of Presendin or a placebo, across 37 centres in Europe, UK, Australia and the United States.
The trial will aim to assess the average difference in intracranial pressure (ICP) from baseline at 24 weeks between patients receiving Presendin and those on placebo. Additionally, the trial will study the relative difference in vision and monthly headache days between the two groups over 24 weeks.
Pending the outcome of the trial, further discussions with the US FDA will take place regarding registration of Presendin in the United States.
“Our aim now is to secure an early market approval for Presendin in the EU, UK and Australia, and to use the data from IIH EVOLVE to further inform the interaction with the FDA and define fully the requirements for approval in the United States,” Invex chairman Dr Jason Loveridge said.
Invex said it aims to have the first IIH EVOLVE clinical trial application filed in the fourth quarter of 2021.
The company said the IIH EVOLVE trial is fully funded from existing cash reserves of $32 million.
Invex Therapeutics is up 14.5 per cent, trading at 75 cents per share as of 10:40 am AEDT.
