Evgen Pharma PLC (LON:EVG) Chief Executive Officer Dr Stephen Franklin caught up with DirectorsTalk for an exclusive interview to discuss obtaining the required approval to start Phase II clinical trial on SFX-01
Q1: You’ve just issued an RNS stating that Evgen Pharma have the required approvals now to start a clinical trial on SFX-01, now that’s in patients that have a type of stroke called a Subarachnoid Haemorrhage. Before we talk about SFX-01, can you tell us what a subarachnoid haemorrhage is and how common is it?
A1: Of course. A subarachnoid haemorrhage or more specifically in this case an aneurysmal subarachnoid haemorrhage is a brain haemorrhage in which an aneurysm ruptures and blood goes into the subarachnoid space around the brain. The ‘arachnoid’ literally comes from the word spider so when you scan the brain you can see the blood all around in this protective barrier forming the shape of a spider. An aneurysmal subarachnoid haemorrhage accounts for 1 in every 20 strokes in the UK and approximately 600,000 individuals suffer from it worldwide each year.
Q2: Why would SFX-01 be expected to help patients who have suffered a subarachnoid haemorrhage?
A2: Well the current standard of care for patients with subarachnoid haemorrhage is to repair the aneurysm surgically to prevent a rebleed however the real complications of a subarachnoid haemorrhage unfold in the days after the original bleed. So after a few days the free residual haemoglobin from the blood breaks down and create a toxic environment, this toxicity generates oxidative stress and the blood vessels start to constrict and close down, the result in lack of blood flow can lead to neurological damage in the brain. So it’s interesting that it’s not the initial bleed per se that causes a lot of the neurological damage, in the surviving patients it’s the secondary stroke which follows a number of days later. Now the current treatment is to use a drug called Nimodipine which has been around for about 20 years now and this can reduce the constriction of blood vessels and thus try to minimise the damage however the benefits are modest at best. Now SFX-01 represents a potential new therapeutic approach by targeting the actual underlying causes of the secondary stroke so by specifically targeting the Nrf2 pathway one can mop up the toxic factors from the free blood, reduce the oxidative stress and thereby leave the brain less prone to a secondary stroke.
Q3: How long will it take Evgen Pharma to complete this study and what happens then?
A3: So the trial is scheduled to complete and report in late 2017 however it is worth noting that the trial has been statistically-powered to make a conditional market approval possible in the event that the data is positive so subarachnoid haemorrhage is a relatively rare condition and therefore presents the potential to secure, in due course, orphan designation for SFX-01. The benefits to a small pharma company are many and include speed to market and market exclusivity but the ultimate corporate objective remains unchanged and that is to monetise SFX-01 at the appropriate time via licencing and/or an outright acquisition of the business.
