Novartis provides update on phase 2b ENCORE-LF trial in NASH cirrhosis

Jun 24, 2019
  • Conatus today announced top-line results from the ENCORE-LF trial, which did not meet its primary endpoint
  • Novartis remains fully committed to pursuing the development of multiple compounds in collaborations
  • Novartis is investing in one of the broadest pipelines in the industry for non-viral liver diseases, investigating mono and combination therapies
  • There are currently no approved pharmacological treatments for non-alcoholic steatohepatitis (NASH), which affects up to 5% of the population worldwide[1], [2]

Basel, June 24, 2019 - In collaboration with Novartis, ENCORE-LF is a phase 2b trial that Conatus Pharmaceuticals Inc. conducted to evaluate emricasan (VAY785) in patients with decompensated NASH cirrhosis. Conatus announced this trial did not meet its primary endpoint of event-free survival relative to placebo.

"NASH is a complex, poorly understood condition with no currently available pharmacotherapy treatment options" said Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology. "The data gathered as part of the ENCORE program are critical in advancing our understanding of NASH. We remain fully committed to pursuing the development of our multiple compounds, partnerships and new technologies to tackle this challenging-to-treat disease, which impacts up to 5% of the world's population."

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 105 000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

References
      [1]   Vernon G et al. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011;34(3):274-85.
      [2]   Younossi ZM et al. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatol. 2016;64(1):73-84.

# # #

Novartis Global External Communications
E-mail: [email protected]

Antonio Ligi
Novartis Global External Communications
+41 61 324 1374 (direct)
[email protected]
Friedrich von Heyl
Novartis Global Pharma Communications
+41 61 324 8984 (direct)
+41 79 749 0286 (mobile)
 [email protected]