Invex Therapeutics Ltd - Entering Phase III

Business model

Invex Therapeutics is focused on developing treatments for neurological conditions resulting from or involving raised intracranial pressure, which can occur due to several conditions including traumatic brain injury, blood clots and blockages, brain tumours, stroke and infections leading to meningitis. Invex is currently focused on ICP caused by idiopathic intracranial hypertension (IIH), a rare but increasing condition found most often in women with obesity aged from 15 to 60 years. This condition currently has no treatment options but can result in debilitating daily headaches and permanent loss of sight for the patient. Invex was founded to advance research conducted at the University of Birmingham by Professor Alexandra Sinclair in intracranial pressure-related neurological disorders.

Greenlighted to commence IIH EVOLVE Phase III in the US

The company announced in August that it had received IND approval from the US FDA for PresendinTM and for commencement of the IIH EVOVLE Phase III clinical trial in the US. Invex noted that it was on-track to recruit its first patient into the trial during the second half of CY2022 and that it was progressing the opening of leading clinical sites across the US to support the trial. The IIH EVOLVE trial is a randomised, placebo-controlled, double-blind trial that will select 240 patients with newly diagnosed IIH to determine the efficacy and safety of PresendinTM against placebo, administered once weekly over 24 weeks. The primary endpoint of the trial is the change of intracranial pressure from the baseline, with key secondary endpoints being vision and headache outcome measures. Invex expects to operate the trial across 40 clinical sites globally.

Peers are other companies seeking to repurpose drugs

Companies at a similar stage in their journey include Island Pharmaceuticals (ASX:ILA) and Paradigm Biopharmaceuticals (ASX:PAR). ILA is a mid-clinical stage antiviral drug development company focused on its Phase IIa clinical trials. Paradigm is a late-stage drug development company undertaking to develop and commercialise Pentosan polysulfate sodium for the treatment of pain associated with musculoskeletal disorders. Both companies are seeking to repurpose an already approved drug. It is worth noting that companies seeking to repurpose drugs generally bring them to market quicker due to their prior safety approval, however, a downside risk is that repurposed drugs generally have less patent protection, although Invex has secured orphan drug designation in the US and Europe in IIH for Exenatide, providing 7 and 10 years market exclusivity, respectively, in these markets.