- Invex Therapeutics (IXC) reports lower-than-expected enrolment for its intracranial hypertension (IIH) EVOLVE phase III trial for patients with idiopathic IIH
- IXC set out to enrol 240 IIH patients across 40 global sites
- As of June 26, Invex announced it had enrolled just 13 patients and activated only 12 sites out of a planned 40, globally
- As a result, IXC announced it would make significant amendments to the study protocol of the trial, which would then require ethics approval
- IXC shares plummeted 49.5 per cent, trading at 23 cents at 3:31 pm AEST
Invex Therapeutics (IXC) has reported lower-than-expected enrolments for its intracranial hypertension (IIH) EVOLVE phase III trial for patients with idiopathic IIH.
The company set out to enrol a total of 240 patients with newly diagnosed IIH, with recruitment expected to take up to 24 months.
As of June 26, Invex announced it had enrolled just 13 patients and activated only 12 sites out of a planned 40, globally.
The company also noted the rapidly evolving market uptake of GLP-1RAs which are used for the treatment of obesity, as reasons for setbacks.
Meanwhile, regulatory approvals across Germany, Israel, and France have also played their part in delaying the process, along with “significantly higher failure rate(s) than
initially anticipated” at some sites.
As a result, IXC announced it would make significant amendments to the study protocol of the trial, which would then require ethics approval. The company will keep its primary goal of assessing the change in intracranial pressure (ICP) from baseline at 24 weeks the same.
There will be adjustments made to secondary endpoints and other protocol changes such as the extension of diagnostic lumbar punctures to within six months of enrolment, allowing for a broader range of recently diagnosed patients to participate.
The required sample size for the trial has also decreased from 240 to 130 patients.
IXC shares plummeted 49.5 per cent, trading at 23 cents at 3:31 pm AEST.