Could personalised medicine change treatment for migraine?
The concept of personalised medicine is becoming established in cancer, with an increasing number of drugs targeting specific mutations making it to market. Alec Mian, CEO at diagnostics firm Curelator, spoke to pharmaphorum’s news editor Richard Staines about the company’s plans to apply a similar paradigm to other diseases such as migraine.
There has been noticeable progress in migraine as a disease area in the last few years, with a new class of drugs coming to market that could help prevent debilitating attacks.
But the underlying causes of the disease are still mysterious and it’s still difficult to predict which patients will respond to these and other treatments.
Curelator is working on a system that aims to change all this, using a unique approach based around personalised disease management tools that allow patients to better understand the triggers for migraine attacks.
The technology known as N1-Headache allows people to use a smartphone to enter data about their symptoms, which it uses to create personalised analytics.
After 90 days of data entry, the app creates a trigger, protector and “no association” map for each use within a personalised report.
This information enables patients and clinicians to generate individual profiles to manage risk factors and therapeutic response to drugs and monitor potential medication overuse.
Curelator has already helped with a study that questions established thinking about the condition, ruling out stress as a trigger in many cases.
Using Curelator’s technology, the study conducted by researchers from the University of Calgary found there was a surprising lack of association between a patient’s perception of stress and migraine episodes.
Only 7.1% of patients had a majority of their attacks associated with increased levels of perceived stress and 76% of the total number of migraine attacks were associated with either flat or decreasing levels of perceived stress.
The study is the largest stress-migraine study to date, following 351 patients over three months and analysing 2115 migraine episodes.
In an interview with pharmaphorum, CEO Alec Mian said that the company’s first goal is to get a better understanding of the root causes of the disease and its different subtypes.
He said: “What we have developed is a measuring platform. It says you are this kind of patient and this is the intervention that suits you.”
Mian expects Curelator to come into its own in the coming years as recently approved migraine drugs become more established.
Calcitonin gene-related peptides (CGRPs) offer a new treatment paradigm by preventing onset of attacks, but they don’t work in all patients.
“CGRPs are all incredibly similar and work in about 50% of patients and reduce headaches by 50%. We need to find out who those 50% actually are,” said Mian.
Market challenges
But marketing the system won’t be as simple as a drug, according to Mian.
He has some colourful language to describe the US market, where he does not expect the product to gain much traction.
The US system is too fragmented for the kind of service offered by Curelator, which would aim to get maximum value from already-marketed drugs.
“Payers, providers, the electronic health records… they have a lock on everything. We have a commercialisation effort and we have made some progress, but it is messed up in the US.”
However it’s different story in Europe, where payers are keen to see a return on their investment in medicines, with arrangements in place that could asses the value of tools such as Curelator.
Germany has been pioneering the use of digital therapeutics and has a specialised reimbursement system in place to encourage use of these tools.
While Curelator’s technology isn’t strictly a digital therapy, it has the potential to become used as an intervention once the data is there to support it.
This point is quite far off, but nevertheless Europe is the target market, thanks to the joined-up nature of the healthcare systems there.
“The UK and Germany have their act together. In Germany there is reimbursement and protocol in place. The EU is ahead of the states when it comes to digital health. Europe is the place to commercialise,” he said.
The project is very much a long-term one and funding is set up accordingly, with backing from some “resilient” investors who are prepared to wait for longer than a decade for the project to come to fruition.
Mian is not interested in working with venture capitalists, who won’t have the patience to see the project through to its conclusion.
“It’s unfinanceable by VCs. They want money back in ten years and that is not going to happen,” according to Mian.
“The path is very un-VC but there are a lot of assets that are not commercially obvious in the long term.”
But he’s quite clear that the project will produce rewards in the long run given the appetite in Europe for ways to make medicine more cost-effective.
“I think we will make a ton of money,” Mian concluded.
