NASH News January 2020
Fatty liver disease (FLD) and non-alcoholic steatohepatitis (NASH) are increasing in prevalence worldwide, creating a major global public health crisis. To adequately educate patients, practitioners and policy makers, there is a need to collect, curate and share relevant information. NASH News, published on behalf of the Global Liver Institute’s NASH Council, intends to meet that need and to facilitate collaboration across the emerging NASH community on a monthly basis.
We would appreciate your feedback and content contributions. Please contact nash@globalliver.org
2020 - The Year of the NASH Patient
NASH has undergone an incredible evolution in a very few years - from unknown conditions (except for a few dedicated researchers) to the talk of this month’s J.P. Morgan Conference. NASH is now a hot topic at medical conferences and investor circles. I believe that 2020 will be distinguished by the elevation of and appreciation for the NASH Patient. I specifically do not use the term “patient voice” because we are so much more than just a voice - we are a force.
Watch for:
Patients setting policy for NASH An increasing number of patients are engaged in developing a US NASH Action Plan including passage of the LIVER Act and a Patient’s Forum in Europe.
Patients defining value in NASH GLI has led communication with ICER, and I have recently joined the Innovation Value Initiative (IVI) chaired by former Anthem Chief Medical Officer Sam Nussbaum.
Patients demanding non-invasive screening and staging alternatives to biopsy The GLI Beyond the Biopsy campaign is growing in staff and activities in both the US and EU, bringing devices, labs, and payers into the NASH conversation with us.
Patients mentoring other patients and designing optimal clinical navigation and life management strategies for living with NASH.
Patients engaged in regulatory communications and data submissions in support of the approval of safe and effective NASH therapies.
Patients working alongside other stakeholders to shape the future of NASH research, drug development, public health surveillance, real-world evidence generation, reimbursement, prevention, screening, linkage to care, and access to therapy.
Donna R. Cryer, JD
President & CEO
Global Liver Institute
Updates
Study Finds One in Every Three Persons in Delhi has an Unhealthy Liver
35.5% of people — one out of every three persons examined — had liver fibrosis. Nearly 14% had advanced stage liver fibrosis, which, if not treated, can result in irreversible liver damage, and 3% had probable cirrhosis, end-stage liver disease.
FDA advisory committee for Ocaliva set for April 22, 2020. PDUFA target action date extended to June 26, 2020
On December 13, 2019, Intercept Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration had notified the Company that it was tentatively scheduling an advisory committee meeting relating to the Company’s New Drug Application for obeticholic acid in liver fibrosis due to NASH for April 22, 2020.
Economic and Clinical Burden of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes in the U.S.
We estimated that there were 18.2 million people in the U.S. living with T2DM and NAFLD, of which 6.4 million had NASH. Twenty-year costs for NAFLD in these patients were $55.8 billion. Over the next 20 years, NASH with T2DM will account for 65,000 transplants, 1.37 million cardiovascular-related deaths, and 812,000 liver-related deaths.
NASH Clinical Update: What to Expect in 2020
Beyond the absence of an approved therapy and the size of the potential patient pool, NASH is an intriguing disease for basic and discovery research. A variety of metabolic, hormonal, inflammatory, and fibrotic mechanisms interplay in its development and progression, presenting a variety of axes to target for disease management and resolution. The 2019 field of clinical candidates exemplify the complexity and richness of therapeutic targets.
Half of the U.S. Population Will Be Obese by 2030
Using current trends in overweight and obesity from each state, the researchers projected into the future and found that by 2030, one in two adults in the U.S. will be considered obese, and one in four will be considered severely obese, with a BMI of 40 or higher. In 29 states, obesity rates will climb to over 50%.
NASH kNOWledge Releases New NASH Infographic in English and Spanish
Fish Oil Pill for NASH? Dutch Biotech Scores $40M Injection to Make a Mark in the Bustling Field
The funds will be used to complete an ongoing Phase IIb NASH study, which is expected to be completed by 2021, as well as the development of two other omega 3 compounds for use in dyslipidemia and an orphan liver condition called PNALD (parenteral nutrition-associated liver disease) respectively.
The Phantom Menace - In NASH, Researchers Battle a Largely Invisible Threat
She might feel okay, but her doctor had a nagging suspicion that her liver was feeling otherwise, that Margaret’s lifestyle had caught up with her. He suspected that fat was building in her liver in a condition known as non-alcoholic fatty liver disease or NAFLD.
Cirius Withdraws $86M IPO as Vaunted 'Year of NASH' Draws to Brutal Close
Although NASH – or nonalcoholic steatohepatitis – is thought to affect about 50 million Americans and is marked by damaging liver scarring and fat buildup, most patients have never heard of the condition and don’t know they have it.
Boehringer Ingelheim Inks 'Singapore's Largest Biotech Deal,' Promising $1B Each for a Suite of Anti-fibrotic IL-11 Drugs
The biotech is now eligible for $1 billion in milestones for each antibody program to emerge out of its pipeline covering NASH, cardiac fibrosis, idiopathic pulmonary fibrosis, and more.
Watch This Event - Leveraging Clinical Pharmacology to Optimize Drug Development for Nonalcoholic Steatohepatitis (NASH) and Cholestatic Liver Diseases
To further assist in drug development for NASH and cholestatic liver disease indications, Duke-Margolis and the FDA convened a public meeting in December to discuss clinical pharmacology-driven considerations and promising approaches to optimize drug safety and efficacy.
GLI NASH Partner Highlight
Institute of Liver Disease, King's College, London
The Institute of Liver Studies at King’s College is the largest hepatology center in Europe in which 200 liver transplants, 3000 adult and 500 pediatric new referrals are cared for annually. The Institute’s mission is to produce research outcomes that impact directly on patient care by:
Perfecting surgical techniques
Supportive management of the failing liver
Clarifying mechanisms of liver damage to develop specific and more efficient modes of treatment
The main research areas of the Institute are - innovative therapy, supportive management of liver failure, immunopathology and the genetics of liver disease.
The Institute of Liver Studies supports King’s Liver laboratories (made up of liver pathology and academic laboratories). They in turn support and assist the development of hepatology, liver transplantation, and hepato-pancreatic-biliary services. Work conducted in the laboratories has a strong focus on diagnostics and clinical-academic translational research.
Global Liver Institute Partner Events
5/1-3/2020 - Cardiometabolic Congress West - Scottsdale, AZ, USA
6/26-28/2020 - Medical University of South Carolina Metabolic Disorders Conference - Kiawah Island, SC, USA
10/21-24/2020 - Cardiometabolic Congress - Boston, MA, USA
Upcoming Events
03/13-14/2020 - Swiss Autoimmune Liver Patient conference - Lugano, Switzerland
04/15-19/2020 - EASL 2020 - London, UK
5/2-5/2020 - Digestive Disease Week - Chicago, IL, USA
5/4-7/2020 - 4th Annual NASH Summit - Boston, MA, USA
7/8/2020 - The Liver Forum Meeting - Paris, FRA
7/9-10/2020 - Paris NASH Meeting - Paris, FRA
11/13-17/2020 - The Liver Meeting - Boston, MA, USA