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Will FDA Approve First NASH Drug In 2020?

pfizer april09 lt

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.NoCompanyDrug NamePhase Of TestingAnticipated Milestone
1Genfit SA (GNFT)ElafibranorPhase 3 (RESOLVE-IT)Topline interim results from RESOLVE-IT expected by end of May 2020
2Allergan plc (AGN)CenicrivirocPhase 3 (AURORA) Topline data expected in Q4, 2020
3Galmed Pharma Ltd. (GLMD)AramcholPhase 3/4 (ARMOR) Topline results by Q4, 2022
4Madrigal Pharma (MDGL)ResmetiromTwo Phase 3 trials - (MAESTRO-NASH and MAESTRO-NAFLD-1)52 week readout by the end of 2021
5Galectin Therapeutics Inc. (GALT)BelapectinDue to enter Phase 3 in Q2, 2020 (NASH-RX)Might be delayed due to the COVID-19 pandemic
6Immuron Limited (IMRN)IMM-124EPositive Phase 2 results reported in Mar.2018-
7Akero Therapeutics Inc. (AKRO)AKR-001Phase 2 study (BALANCED) met primary endpointTop-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in Q2, 2020
8Albireo Pharma Inc. (ALBO)ElobixibatPhase 2Topline results in mid-2020
9AstraZeneca PLC (AZN)CotadutidePhase 2Primary completion date in Nov.2020
10Bristol-Myers Squibb Co. (BMY)PEG-FGF21Two Phase 2b trials (FALCON 1 and FALCON 2)Primary completion dates in Nov. 2020 and Oct. 2021
11Can-Fite BioPharma Ltd (CANF)NamodenosonPhase 2 study completed in Israel Expected to move into next phase of clinical development
12Eli Lilly and Co. (LLY) TirzepatidePhase 2 (SYNERGY-NASH) Primary completion date in Mar.2022
13Enanta Pharmaceuticals, Inc. (ENTA)EDP-305Phase 2b study (ARGON-2) paused due to COVID-19 pandemic -
14Inventiva S.A. (IVA.PA)LanifibranorPhase 2b (NATIVE) Head-line results in June 2020
15MediciNova Inc. (MNOV)MN-001Phase 2 trial terminated early in April 2018 based on the significant positive results from an interim analysis-
16NGM Biopharmaceuticals Inc. (NGM)AldaferminPhase 2b (ALPINE 2/3)Topline data from ALPINE 2/3 in the first half of 2021
17NovartisTropifexoPhase 2b (FLIGHT-FXR)Full 48-week biopsy data expected in Q2, 2020
18Novo Nordisk A/S (NVO)SemaglutidePhase 2 Results expected in 1H, 2020
19 Pfizer (PFE)PF_0683591916 week Phase 2a study Primary completion date in Dec. 2020
20Pfizer (PFE)PF-06865571 plus PF-05221304Phase 2 expected to begin in June 2020 Primary completion date in Oct. 2022
21Viking 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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