A UK company which has developed software that could make clinical trials using digital imaging faster, cheaper and more accurate has won a £930,000 ($m) funding award that could see it through to profitability.
IXICO is already making revenues off the back of its software, which analyses images generated from technologies such as magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET), but is expecting the business to accelerate as the use of imaging in trials increases.
Prof Derek Hill, chief executive and one of the founders of IXICO, told PharmaTimes that one of the main drivers for the adoption of imaging in clinical trials has been efforts by regulatory agencies, particularly the US Food and Drug Administration, to see imaging biomarkers used as surrogate endpoints in studies.
The imaging technologies that are perhaps most likely in the near-term to emerge as a accepted surrogate endpoints are PET scanning in oncology and MRI in Alzheimer’s disease, said Prof Hill.
But one barrier to the adoption of imaging has been that current approaches to medical imaging analysis “rely on highly-skilled radiologists and technicians’ reading’ and painstakingly comparing images that are often acquired at different centres and different points in time.”
“This process is expensive, time consuming and subject to error,” said Prof Hill, adding that there have been instances where clinical trials using imaging – including Phase III trials that may cost hundreds of millions of dollars to run - have not passed muster at the FDA because the imaging analyses have not been carried out in a sufficiently standardised way.
IXICO’s software is more reliable, processes images faster and also makes sure that the resulting data is in a format that will be acceptable to regulators, he said.
Moreover, the technology can also quantify changes in a patient over time, and so can be used in some cases to gauge effectiveness, even in early-phase studies, which could allow sponsors to make earlier decisions about the potential of a drug candidate.
Fail faster, fail cheaply
Earlier this year, market research organisation Business Insight placed a figure on the amount of money that could be saved using this type of technology, saying “it is estimated that between $10 million and $30 million could be saved per drug programme through the use of advanced imaging technologies which could guide go/no go decisions.”
For example, IXICO has one study ongoing comparing several compounds for a particular indication in order to select the best candidate to take forward into further testing. In this case, the form should achieve in just three months what had taken 18 months for the previous generation of compounds.
At the moment the two disease areas that IXICO is working on most are Alzheimer’s disease and rheumatoid arthritis, both of which are slowly progressing diseases and so lend themselves to analysis using IXICO’s quantitative technology.
The company is looking at both established imaging technologies in these areas – such as bone erosion in RA and the site and size of lesions in the brain in AD – as well as newer techniques such as dynamic contrast MRI.
“Dynamic contrast MRI is a very exciting way of rapidly assessing whether a drug is having an effect, particularly if it is supposed to have an impact on inflammation or on vascular factors such as the permeability of blood vessels, which can be important in oncology,” said Prof Hill.
IXICO has adopted a flexible business model for its software. One revenue stream comes from the contract analysis of digital images from trials carried out by a drug sponsor, something that IXICO can handle in-house if the studies are small. For larger trials, the UK firm has forged an alliance with Bio-Imaging Technologies, a contract research organisation (CRO) that specialises in imaging studies.
Another possibility – which has not yet been explored – is for IXICO to license out the technology to trial sponsors who could use it in-house.
And in time, this type of software could also find its way into the healthcare setting to select patients for treatment, as drugs which have been approved on the basis of trials using precise, quantitative imaging reach the market
“One of the opportunities for our business growth will be the translation of our technologies into a healthcare setting,” said Prof Hill.
He noted that the £930,000 raised by IXICO to date would see it through to profitability, but that the firm would be more likely to seek another round to accelerate the growth of the business ‘in order to meet the opportunity in the market and avoid competitors coming in and beating us to it’.
At the moment the closest competitor to IXICO in terms of technology is US company VirtualScopics, which was set up in 2000 and started trading on the Nasdaq in May. VirtualScopics had turnover of $3.4 million last year, and has set itself the target of growing to $100 million in annual sales.