Hiding in Plain Sight Finding the NASH Patient

Transcription

1 Hiding in Plain Sight Finding the NASH Patient

2 The Silent Disease Nonalcoholic fatty liver disease (NAFLD) and its advanced form, nonalcoholic steatohepatitis (NASH), are increasingly prevalent today and are characterized by a low diagnosis rate and a lack of approved therapies % of US adults have NAFLD 1 11 million US adults have NASH % of all adults have NAFLD, predominantly in the Western world 3 46% of survey respondents with associated risk factors reported a prior diagnosis of NAFLD 4 11% reported a NASH diagnosis 5 2 1, 2,, 4, 5 Acurian National Liver Health Survey 3

3 The Patient Voice Hover over the speech bubbles to read patient stories. A Diagnosis Dilemma NAFLD s silent nature, often presenting with no clinically significant symptoms, delays diagnosis and treatment. NASH diagnosis rates are even lower, often detected incidentally while evaluating for another condition, or when liver damage has progressed. Most of these patients are seen by primary care physicians without the means to diagnose them. As a result, many patients do not obtain specialist care. A definitive diagnosis of NASH traditionally required an invasive liver biopsy, but a presumed NAFLD or NASH diagnosis can be made without confirmation by histology (without a biopsy). Such a diagnosis may be based on imaging (ultrasound or FibroScan), labs (liver function tests), and patient history. Less than half of those reporting a prior diagnosis of NASH underwent a liver biopsy 6 Only 24% of gastroenterologists and hepatologists routinely perform liver biopsies 7 3 6, 7 Acurian National Liver Health Survey 7 n = 163 physicians; predominantly performed among patients with elevated serum aminotransferases

4 The Challenge NASH clinical trials often seek to enroll patients who already have this diagnosis, or who can be diagnosed at screening, posing challenges. The lack of prior diagnosis via liver biopsy limits the applicable patient pool. Yet, NAFLD / NASH clinical research has become crowded, with many companies and compounds competing for few available sites and patients. Finding patients for NASH studies is like trying to find a needle in a haystack. 0.1 patient / site / month Average enrollment for NASH studies in US & Europe Liverline.com Until now. 4

5 Introducing the Acurian / Synexus Enrollment Solution 1 Finding Patients Pre-screen patients with T2D and obesity, over age million in US database Reached via highly targeted marketing 2 Qualifying Patients FibroScan (non-invasive) screening is currently available at select Synexus sites and partner sites. 40% of patients screened have NAFLD 3 Enrolling Patients The patient is sent to a site, where he or she may have a biopsy at screening or have an additional biopsy. Whether the patient goes to a Synexus site initially for less invasive liver screening, or is referred to a study site (with medical records and pre-screening results), Acurian can efficiently manage the NASH enrollment workflow. 25% of NAFLD patients have NASH confirmed on the biopsy Fixed budget enrollment models 5

6 Finding More Patients, Faster Acurian s proprietary database of 100 million households includes thousands of confirmed / diagnosed NAFLD patients, as well as patients at high risk for NAFLD / NASH who can potentially be diagnosed with a screening biopsy. We also have a large pool of patients with co-morbidities (diabetes, obesity, high blood pressure, high cholesterol) known to occur together with NAFLD / NASH. More than 70,000 respondents have self-reported fatty liver disease in Acurian s pre-screening for related conditions, providing a ready-made audience for our targeted messaging and outreach campaigns. Qualified subjects are referred to Synexus sites for trial enrollment. Besides our ability to identify patients who would otherwise go undiagnosed, we have access to more sites and physicians than other companies through Synexus. Targeting Patients diagnosed with NASH via liver biopsy Patients with NAFLD who can be sent to Synexus sites for screening and liver biopsy Patients with metabolic syndrome who have had a FibroScan (non-invasive) screening to qualify them as having NAFLD, and will be referred for a liver biopsy if required to diagnose NASH 6

7 The Right Partner Unmet needs of the NAFLD / NASH population offer tremendous opportunity and ROI, if you partner with the right company. Acurian and Synexus have proven track records enrolling patients in even difficult-to-recruit disease states, through our best-in-class, multi-channel, direct-to-patient identification and engagement capabilities. We Know NASH. Only Acurian and Synexus can address the full spectrum of NAFLD / NASH challenges and deliver high quality patients who meet your stringent criteria, with fixed budget models. We offer greater access to a wider patient population, and a unique approach to finding these patients. Let us help you plan your Phase II or III study, lead patients through pre-screening, and enroll those with the proper diagnosis. To learn more, please call