Lupuzor – the potential new gold-standard treatment for lupus – has started its phase III trial. The drug has been granted special protocol assessment and fast-track approval from the FDA, based on trial findings so far and its benign safety profile. That promises a fast path to market once the trial results have been published – and with pricing likely to be as high as $20,000 per patient per year, and two million patients in G7 countries alone, Lupuzor could very quickly become a multi-billion dollar drug. ImmuPharma chairman Tim McCarthy discusses the phase III trial, the company’s latest fundraising, and the next milestones in development.

The New Economy: Lupuzor – the potential new gold-standard treatment for lupus has started its phase III trial. Joining me is Tim McCarthy, chairman of ImmuPharma, the developer responsible.

Tim – top-line results expected towards the end of 2017, but for now, what progress has been made?

Tim McCarthy: Well, it’s very exciting to be able to announce that we’ve started the phase III study. Any clinical development programme takes a long time from research, all the way through the development process, to market; could take 10-15 years. So to be right at the end now, in the final phase III development is exciting: both for us as a company, but perhaps more importantly for patients.

Because, this is a disease, lupus, which is a severe disease for patients. There aren’t that many effective treatments on the market at the moment. And if we can be successful in this study then it would be fantastic news for these patients.

The New Economy: You kick-started the next stage of development back in December with an investigators’ meeting. Can you talk me through the announcements that were made there, as well as the next milestones that you expect to be crossing?

Tim McCarthy: Yes of course. The investigators’ meeting we held in Paris, just before Christmas, as you say. And that was an opportunity to bring together all the clinicians and lead investigators on the study, from all across the US and across Europe in one place, so they could all compare notes, and we could brief them and make sure everybody is geared up to do the study.

And what we’ve announced since then is the opening of sites in the US, the recruitment of patients and the actual dosing of patients in the US. And that’s up to 10 sites. In Europe we have up to 35 potential sites across six or seven countries. We have already announced that France is open and recruiting. And I’m sure as we go through the next few months we’ll keep the market updated on further patient recruitment, opening of sites in Europe, and moving towards the goal of recruiting 200 patients this year.

The New Economy: Now you raised £8.4m in a share issuance back in February – is this all going into Lupuzor’s development?

Tim McCarthy: Yes, the majority of that money is going to the phase III. That was the primary reason for raising the cash. And let me say: in very challenging capital markets, we were delighted to raise that amount of money. And we got fantastic support from our existing shareholders, including our major investor Aviva.

But we also had some new specialist investors come in, which is always very pleasing. Plus it’s important to say that all of the directors participated in the round as well. And quite unusually, but very pleasing again in terms of external validation, the clinical research organisation Simbec-Orion, that is running this study in conjunction with ourselves, also participated. So to get its involvement was fantastic.

The New Economy: As you say, very challenging conditions to acquire that amount of capital. Talk me through the potential for Lupuzor, and what managed to convince shareholders to invest.

Tim McCarthy: I think it’s a couple of things, when you’re trying to attract both existing investors and new investors into a fundraising.

One is the proposition: in our case, the drug development, based upon the clinical development that we’ve done to date and the results that we’ve seen to date, which have been fantastic. And those all show very good efficacy – the benefit to patients, in terms of their multi-symptoms.

But also as importantly, a very benign side-effect profile. So patients are getting a very good benefit from this drug without any side-effects.

And then on the other side, from a financial perspective of course, one has to look forward to the market potential of a drug like Lupuzor. Pricing could be as high as $20,000 per patient per year. So if one does simple maths and says every 50,000 patients that take this drug at $20,000 per year: that’s $1bn per year. And with up to two million patients available just in the G7 countries, then you can see how this drug can very quickly become a multi-billion dollar drug.

The New Economy: The FDA has accredited Lupuzor with its gold standard. What does this mean, both in terms of the trial itself, and the path to market?

Tim McCarthy: What we have received is called a special protocol assessment from the FDA. They’re not given out very lightly or very often. But what it means is that we have agreed the protocol and the clinical end points with the FDA. And providing we deliver those – which we expect to do – then there is no reason why the drug won’t be approved. And that’s a very important external validation from the FDA. But it also provides a very clear route to market.

In addition to that, we have fast track approval. So normally, when you put your file in with all the clinical data for approval, it will take at least 12 months for the FDA to turn it around. With fast track you get six months. So that halves the time for review.

And I think it’s worth adding here that the number of patients we’ve got in the phase III study is relatively small compared to other phase III studies. And that again just validates the FDA view of the clinical data to date, and the benign safety profile.

The New Economy: The actual path to market still some time away – but for the next 18 months as the trial develops – how are you going to be communicating with your shareholders, and the stakeholders in the lupus community about the progress?

Tim McCarthy: Yes, it’s very important as a public company that we remain communicative with the market in general, and our investors. But also as you say, with the patient community. That we’ll be doing through regular investor relations programmes, proper announcements obviously when important milestones are met. And the most important milestone in the near future is going to be the patient recruitment, as that progresses to our target of 200 patients later this year.

The New Economy: Tim, thank you very much.

Tim McCarthy: Thank you.