EVG.L Share News (EVG)

(Sharecast News) - Clinical stage drug development company Evgen Pharma announced on Wednesday that the last study visit for the last patient entered in the double-blind, placebo-controlled 'SAS' phase 2 clinical trial has taken place.
The AIM-traded firm explained that in the SAS trial, patients were dosed for a maximum of 28 days following a subarachnoid haemorrhage, covering the period at which they were at risk of a delayed cerebral ischaemia (DCI).

Patients were then monitored for a further five months to assess their recovery, by collecting endpoints including cognitive measurements and MRI scans.

The top line results for the primary endpoints of safety and tolerability, and blood flow, along with key secondary endpoints measuring cognition, MRI and biomarkers, were expected to be announced in the fourth quarter of 2019.

Evgen said the trial recruited a total of 104 patients, split into two arms in a randomised, double-blind, placebo-controlled trial.

All patients received 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 1980s, offered a "marginal" clinical improvement only, the company claimed, and thus there remained a large clinical need to reduce the cognitive deficits that could follow a DCI.

The clinical team was now reportedly focussed on the cleaning, validation and analysis of the large volume of data collected in the trial.

Evgen said the SAS trial would be the second phase 2 clinical trial readout from the company in the current year, after it announced in March that SFX-01 had successfully met the primary endpoints in the 'STEM' trial - an open label phase 2 trial in patients with metastatic breast cancer that had become resistant to hormone therapy, and with demonstrable progressive disease.

"We look forward to being able to announce the SAS clinical trial results later this year," said Evgen Pharma chief executive officer Steve Franklin.

"There has been no material innovation, in terms of new drugs for treating subarachnoid haemorrhage (SAH), for approximately 30 years and so a positive readout would represent significant news for the pharmaceutical industry."

Franklin said that on an annual basis, around 75,000 people had a SAH in the US and EU and, based on the most recent analyst forecast, that could translate into peak sales of around $500m.

"We have already secured orphan drug designation in the US and the SAS trial will enable an application for similar status in Europe."