Invex Therapeutics makes progress ahead of IIH EVOLVE phase three clinical trial

Invex Therapeutics (ASX: IXC) is making strong progress in the preparations for its IIH EVOLVE phase three clinical trial, which aims to achieve global registration of the drug Presendin to treat idiopathic intracranial hypertension (IIH).

In a quarterly update released today, the clinical-stage biopharmaceutical company said it filed the first clinical trial application to begin the trial in Australia in December as planned through an application to a specific Human Research Ethics Committee (HREC).

In Australia, HRECs are required under the Therapeutic Goods Act to review and monitor all clinical trials of unregistered drugs. If successful, HREC clearance will allow Invex to start recruiting IIH patients under the parameters of the approved trial protocol.

Invex said “a number” of clinical sites in Australia are planned and it anticipates completing additional clinical trial applications for the United Kingdom, Europe and the Unites States during the first half of 2022.

Phase three clinical trial preparations

Following significant scientific and regulatory consultation, Invex finalised its overall regulatory and clinical trial strategy during the December quarter.

The planned single phase three clinical trial has been designed to meet the requirements for market approval of Presendin for the treatment of IIH in the European Union, the UK and Australia.

The trial plans to enrol 240 newly diagnosed IIH patients who will be randomised to receive either once-weekly sub-cutaneous injections of Presendin or placebo across 37 trial centres in Europe, the UK, Australia and the US.

The primary endpoint of the trial will assess the mean difference in intracranial pressure from baseline at 24 weeks between patients receiving Presendin and the placebo.

Secondary endpoints will assess the relative difference in vision and monthly headache days between the two groups over the 24 weeks.

Outcomes from the trial are expected to facilitate future discussions with the US Food and Drug Administration (FDA) regarding the registration of Presendin in the US.

A milestone in the trial preparations was the appointment of Professor Michael Wall as the trial steering group chairperson. Professor Wall is considered a distinguished professional in the field of IIH who has published widely and has significant experience and expertise in the execution of clinical trials in neurology and ophthalmology.

Tax rebate received

Also during the quarter, Invex’s UK subsidiary received about £100,000 (A$184,000) in a research and development tax rebate from the UK government for the 2021 financial year.

The company said it anticipates an increase in UK rebates and the commencement of Australian research and development tax rebates in future periods as it advances expenditure necessary to support its registration-directed IIH EVOLVE phase three trial.

Initial purchase order placed with Peptron

Following its major long-term collaboration and manufacturing agreement with Peptron during the September quarter, Invex reported a satisfactory independent qualified person audit of Peptron’s manufacturing facility in Korea, which can produce more than 48,000 vials of Presendin per month, as well as one other key supplier.

This satisfactory audit and the subsequent certification of manufactured batches of drug product by a qualified person is a requirement under EU and UK law prior to importation of the product into the regions for clinical or commercial purposes.

Following this successful audit, Invex has placed an initial purchase order with Peptron to supply a clinical batch of Presendin and placebo product for the IIH ELVOLVE trial. Invex’s storage and distribution partner expects to take delivery shortly and complete necessary labelling requirements necessary for dispatch to clinical sites once they open.

Fully funded for trial

Invex reported cash and cash equivalents standing at $31.4 million at the end of the December quarter.

Overall cash outflows for the quarter totalled $600,000, including product manufacturing and operating costs relating to Presendin and placebo purchases in preparation for the IIH EVOLVE phase three trial, research and development expenditure as well as admin and corporate costs.

The company stated it is fully funded to complete its IIH EVOLVE phase three trial from current cash reserves.