(Alliance News) - Evgen Pharma PLC said Wednesday it has entered its last patient in the double-blind, placebo-controlled SAS Phase II clinical trial that is testing its SFX-01 product, aimed at improving the treatment of strokes.
The trial is for patients who have just suffered from a subarachnoid haemorrhage and are at risk of a delayed cerebral ischaemia. Patients are dosed for a maximum of 28 days and are then monitored for a further five months, assessing recovery by collecting endpoints including cognitive measurements and MRI scans.
The top-line results for the primary endpoints of safety, tolerability and blood flow, along with key secondary endpoints measuring cognition, MRI and biomarkers, are expected to be announced in the fourth quarter.
"We look forward to being able to announce the SAS clinical trial result later this year. There has been no material innovation, in terms of new drugs for treating subarachnoid haemorrhage, for approximately thirty years and so a positive readout would represent significant news for the pharmaceutical industry," said Chief Executive Steve Franklin.
The trial entered 104 patients, split into two, with some receiving the "current standard of care" - a calcium channel blocker called Nimodipine in addition to SFX-01 - or the placebo.
"Nimodipine, first approved in the late eighties, offers a marginal clinical improvement only and there remains a large clinical need to reduce the cognitive deficits that can follow a delayed cerebral ischaemia," the company added.
Franklin continued: "On an annual basis, around 75,000 people have an subarachnoid haemorrhage in the US and EU and, based on the most recent analyst forecast, this could translate into peak sales of approximately USD500 million. We have already secured orphan drug designation in the US and the SAS trial will enable an application for similar status in Europe."
Shares in Evgen Pharma were 5.0% lower in London on Wednesday at 16.99 pence each.
