Drinking too much alcohol can lead to the accumulation of fat in the liver, which in turn can lead to irreversible damage to the organ over the long run. But people who don’t drink or drink very little also can develop a liver disease, which goes by the name non-alcoholic fatty liver disease, or NAFLD, a condition caused by the buildup of extra fat in liver cells.
The most severe form of NAFLD is known as non-alcoholic steatohepatitis, or NASH.
It is estimated that between 30 and 40 percent of adults in the United States have NAFLD, and about 3 to 12 percent of adults in the United States have NASH. (Source: National Institute of Diabetes and Digestive and Kidney Diseases). Currently, there are no FDA or EMA-approved treatments for NAFLD or NASH.
However, there is one approved NASH drug by the name Saroglitazar, developed by India’s Zydus Cadila. The drug, which was greenlighted by the Drug Controller General of India, last month, is the world’s first-ever NASH treatment.
A number of companies are developing drugs for NASH, and the most advanced player among them is Intercept Pharmaceuticals Inc. (ICPT).
Intercept’s investigational NASH treatment Obeticholic acid is tentatively slated to be reviewed by an FDA panel on June 9, 2020, and a final decision is expected on June 26, 2020. If all goes well as planned, Obeticholic acid could be the first FDA-approved product for NASH.
The following table lists the NASH drugs in phase III and phase II development stages and the anticipated milestones. (Only publicly-listed companies are included in the list).
|S.No||Company||Drug Name||Phase Of Testing||Anticipated Milestone|
|1||Genfit SA (GNFT)||Elafibranor||Phase 3 (RESOLVE-IT)||Topline interim results from RESOLVE-IT expected by end of May 2020|
|2||Allergan plc (AGN)||Cenicriviroc||Phase 3 (AURORA)||Topline data expected in Q4, 2020|
|3||Galmed Pharma Ltd. (GLMD)||Aramchol||Phase 3/4 (ARMOR)||Topline results by Q4, 2022|
|4||Madrigal Pharma (MDGL)||Resmetirom||Two Phase 3 trials – (MAESTRO-NASH and MAESTRO-NAFLD-1)||52 week readout by the end of 2021|
|5||Galectin Therapeutics Inc. (GALT)||Belapectin||Due to enter Phase 3 in Q2, 2020 (NASH-RX)||Might be delayed due to the COVID-19 pandemic|
|6||Immuron Limited (IMRN)||IMM-124E||Positive Phase 2 results reported in Mar.2018||–|
|7||Akero Therapeutics Inc. (AKRO)||AKR-001||Phase 2 study (BALANCED) met primary endpoint||Top-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in Q2, 2020|
|8||Albireo Pharma Inc. (ALBO)||Elobixibat||Phase 2||Topline results in mid-2020|
|9||AstraZeneca PLC (AZN)||Cotadutide||Phase 2||Primary completion date in Nov.2020|
|10||Bristol-Myers Squibb Co. (BMY)||PEG-FGF21||Two Phase 2b trials (FALCON 1 and FALCON 2)||Primary completion dates in Nov. 2020 and Oct. 2021|
|11||Can-Fite BioPharma Ltd (CANF)||Namodenoson||Phase 2 study completed in Israel||Expected to move into next phase of clinical development|
|12||Eli Lilly and Co. (LLY)||Tirzepatide||Phase 2 (SYNERGY-NASH)||Primary completion date in Mar.2022|
|13||Enanta Pharmaceuticals, Inc. (ENTA)||EDP-305||Phase 2b study (ARGON-2) paused due to COVID-19 pandemic||–|
|14||Inventiva S.A. (IVA.PA)||Lanifibranor||Phase 2b (NATIVE)||Head-line results in June 2020|
|15||MediciNova Inc. (MNOV)||MN-001||Phase 2 trial terminated early in April 2018 based on the significant positive results from an interim analysis||–|
|16||NGM Biopharmaceuticals Inc. (NGM)||Aldafermin||Phase 2b (ALPINE 2/3)||Topline data from ALPINE 2/3 in the first half of 2021|
|17||Novartis||Tropifexo||Phase 2b (FLIGHT-FXR)||Full 48-week biopsy data expected in Q2, 2020|
|18||Novo Nordisk A/S (NVO)||Semaglutide||Phase 2||Results expected in 1H, 2020|
|19||Pfizer (PFE)||PF_06835919||16 week Phase 2a study||Primary completion date in Dec. 2020|
|20||Pfizer (PFE)||PF-06865571 plus PF-05221304||Phase 2 expected to begin in June 2020||Primary completion date in Oct. 2022|
|21||Viking Therapeutics, Inc. (VKTX)||VK2809||Phase 2b (VOYAGE)||Enrollment in ex-US sites to open later this year|
The NASH drug development landscape is fraught with many failures. Last year, Gilead’s Selonsertib in phase III trial and Conatus Pharmaceuticals’ (CNAT) Emricasan in phase 2b trial missed their trial goals while CymaBay Therapeutics Inc.’s (CBAY) phase 2b study of Seladelpar was halted after biopsies revealed atypical histological findings in some patients.
Obesity and type 2 diabetes increase the risk of developing NASH. With the rising prevalence of both obesity and type 2 diabetes, it is only natural that the number of NSAH cases is going to increase. Globally, NASH is prevalent in 10% to 30% of the population.
The global NASH market is expected to reach $13.38 billion by 2026, according to a report that was released last February by Reports and Data.
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