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Evgen Pharma PLC Q&A: Phase II Trials of Lead Drug SFX-01

Evgen Pharma PLC (LON:EVG) Chief Executive Officer Dr Stephen Franklin caught up with DirectorsTalk to discuss the phase II trials of their lead drug SFX-01

 

Q1: Stephen, SFX-01 is your lead drug and now it’s in phase II trials, can you remind us what SFX-01 is and what diseases you’re targeting?

A1: Of course, SFX-01 is a synthetic variant of a natural product called sulforaphane and sulforaphane is this molecule that you get at very low levels when you consume certain brassica’s like broccoli. The key thing is that we are able to synthesise this molecule, stabilise it which is clearly very important for a drug and then deliver it at the doses necessary to treat certain diseases. What we know about sulforaphane, and therefore hopefully SFX-01, is the fact that it’s an established anti-cancer agent, also interestingly it’s a neuroprotectant so that then takes you into the realms of conditions such as MS, Alzheimer’s and Parkinson’s. Specifically what Evgen Pharma is targeting with our first two trials is a neurology indication called subarachnoid haemorrhage which is a rare type of stroke and we’re also targeting advanced breast cancer and that’s typically called metastatic breast cancer.

 

Q2: Now, you released your interim statement this morning, what were the main headlines from that?

A2: It’s all looking positive at the moment so we IPO’d in 2015, we made certain promises on what we would deliver and I’m pleased to say that all those have happened and have come in on time. So we have two phase II trials running, first one in subarachnoid haemorrhage is well into its recruitment and is recruiting patients in line with expectation, and the trial in metastatic breast cancer, which is across Europe, has now opened its first site actually in Belgium so that’s good to go now in terms of recruitment and early next year more European sites will open for that trial. So that’s the main theme, we said we would start two phase II trials and we’ve delivered those.

In addition there’s been other positive developments so on the regulatory front we’ve been given orphan designation by the FDA for SFX-01 for subarachnoid haemorrhage. As it’s a rare disease you can get certain incentives and breaks to enable you to pursue that disease, we have that from the FDA and also we’ve produced some interesting data so some positive data on SFX-01 in Multiple Sclerosis which was presented this September at the big MS conference in London. So a big push I’d say on three fronts, the trials are live, we’ve hit certain regulatory milestones and we’ve had some positive data come out as well.

 

Q3: When can we expect results from the trials and I guess more importantly, do Evgen Pharma PLC have enough cash to get there?

A3: Ok, I’ll take the second one first. Yes we have enough cash to get there, a key part of our IPO proposition was we were only going to raise enough if we knew that we could complete both the phase II trials and get to that value inflection point. So if we were to raise more money we’d be in position where we wouldn’t necessarily have to and we could do if there was a very good reason to do so but we don’t have to and that’s an absolute core message.

In terms of the results, so these trials will now run through 2017, they both report out, read-out, in early 2018, we’ve got the capacity actually to look at putting additional clinical sites into both those trials which would have the net impact of potential bringing them forward in terms of read-outs and that’s something we’re reviewing at the moment. In terms of making a mark in your diary it’s early 2018 at the moment for both trials.

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