Biotech

Invex Therapeutics continues preparation ahead of IIH EVOLVE phase three clinical trial

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By Danica Cullinane - 
Invex Therapeutics ASX IXC idiopathic intracranial hypertension IIH phase 3 drug

According to Invex, there are currently no approved treatments for idiopathic intracranial hypertension.

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Invex Therapeutics (ASX: IXC) is continuing to advance preparations for the launch of its global IIH EVOLVE phase three clinical trial, which aims to determine safety and efficacy of its drug Presendin in treating idiopathic intracranial hypertension (IIH).

The clinical-stage biopharmaceutical company today provided an update on its March quarter activities, reporting the completion of many key service contracts with third party vendors.

These vendors, include a leading contract research organisation in addition to drug importation, packaging, labelling and distribution companies.

Invex has also been working closely with its manufacturing partner Peptron and advisors to complete the necessary technical manufacturing and control documentation, alongside a comprehensive review of non-clinical and clinical data for its drug formulation in preparation for clinical trial applications planned for the United Kingdom, Europe and the United States during the June quarter.

Invex has also identified more than 40 potential clinical sites for its IIH EVOLVE trial with the aim being to open about 37 of these sites across the US, Europe, UK, Australia, New Zealand and Israel.

IIH is a neurological condition which features severely raised intracranial pressure, causing disabling daily headaches and which can compress the optic nerve. Research shows incidence of the condition has increased by more than 350% in the last decade.

Invex’s phase three trial will recruit newly diagnosed IIH patients to receive either once-weekly sub-cutaneous injections of Presendin or placebo to assess the mean difference in intracranial pressure from baseline to 24 weeks.

Secondary endpoints of the trial will assess differences in vision and monthly headache days between the two groups over the same period.

Presentations and peer review

Invex representatives who attended the 48th Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS) in Texas in February said they were “pleased with the interest and engagement” from the neuro-ophthalmology community on the results of the phase two pressure trial and Invex’s plans for the phase three IIH EVOLVE clinical trial.

The company will undertake further presentations at the European Neuro-Ophthalmology Society (EUNOS) meeting in June in Birmingham, UK.

Strong financial position

Invex has maintained a strong financial position, ending the March quarter with cash and cash equivalents of $30.4 million.

Cash outflows amounting to $1 million included operating expenditure relating to research and development, administration and corporate costs.

Invex forecasts product manufacturing and operating costs to rise in the future with additional purchases of drug products expected in subsequent periods as the phase three trial ramps and patient recruitment increases.

The company has declared it is fully funded to complete its trial for Presendin registration purposes in Europe, UK and Australia from current cash reserves.