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- Invex Therapeutics (IXC) receives regulatory approval in the US to launch a phase three trial of its Presendin product for the treatment of idiopathic intracranial hypertension (IIH)
- Alongside the trial approval, the US Food and Drug Administration (FDA) granted Invex Investigational New Drug status for Presendin
- The company says it now intends to open a few clinical sites across the US to support the trial
- Invex also announces its 2022 financial year full-year results, flagging an increased loss after tax to $3.95 million compared to its $2.3 million loss over the 2021 financial year
- Shares in Invex are up 14.29 per cent to 64 cents at 11:29 am AEST
Invex Therapeutics (IXC) has received regulatory approval in the US to launch a phase three trial of its Presendin product for the treatment of idiopathic intracranial hypertension (IIH)
Alongside the approval for the IIH EVOLVE trial, the US Food and Drug Administration (FDA) granted Invex Investigational New Drug status for Presendin.
The trial will be a randomised, placebo-controlled, double-blind trial for 240 patients with newly-diagnosed IIH to determine the efficacy and safety of Presendin versus the placebo, administered once weekly over 24 weeks.
The trial aims to change intracranial pressure in the patients, with a secondary outcome of improving vision and headaches.
Invex Executive Director and Chief Scientific Officer Alex Sinclair said she anticipated a positive efficacy outcome from the study, which would facilitate further discussions with the FDA on the future registration requirements of Presendin.
Professor Michael Wall, the Steering IIH EVOLVE trial group Chairperson, echoed Professor Sinclair’s sentiments in his comments.
“A high calibre randomised controlled clinical trial such as IIH EVOLVE will answer many important clinical questions and better direct IIH patient care leading to potentially the first-ever drug approval for IIH,” Mr Wall said.
“Our team is looking forward to assisting Invex in the management of this important clinical trial.”
The biopharmaceutical company intends to open a few clinical sites across the US to support the trial.
Patients with IIH suffer from severely raised intracranial pressure which causes headaches and can compress the optic nerve. It’s most common in women who are obese.
Further to the FDA trial approval, Invex today released its annual financial report for the 2022 financial year.
In the report, the company flagged an increased loss after tax to $3.95 million compared to its $2.3 million loss over the 2021 financial year.
Shares in Invex were up 14.29 per cent to 64 cents at 11:29 am AEST.
