NASH is a severe, progressive liver disease characterized by the accumulation of excessive fat in the liver. It is associated with inflammation, hepatocyte injury and fibro-genesis, and may worsen into fibrosis/cirrhosis, liver failure and rarely into liver cancer. NASH is the second leading cause for liver damage and considered to be the rapidly growing reason for liver transplantation. Currently, there is no Food and Drug Administration (FDA) approved drugs for NASH, this is due to the complex multidirectional pathophysiciological crosstalks involved in the NASH pathogenesis, thus, the ability to cure remains one of the major unmet need.
Since NASH and related metabolic diseases represent an economic burden, finding a minimally invasive drug delivery system with high efficacy, low side effects, and cost effective drug/technique to diagnose NASH is a priority. At present there are 50 molecules in phase 2 and above clinical trials stage, which are waiting to enter the market in couple of years with FDA approval. 24% of the clinical candidates have been Fast Tracked and 4% molecules have breakthrough approvals. These candidates combat NASH by addressing multiple mechanisms (Anti-inflammation, Anti-fibrosis and Anti-metabolic) involved in the progression of the disease. Diagnosis of NASH still requires histological confirmation and there is a great demand for specific non-invasive diagnosis for distinguishing NASH from other liver diseases. Therefore, there is a need to develop better diagnostic and therapeutic strategies for patients with NASH. There is one such assay developed by Biocellvia for NASH, which enables highly precise analysis of steatosis, fibrosis and inflammation which will globally accelerate the preclinical drug development with accurate data validation.
Majority of the NASH pipeline drugs are from specialized small to midsized pharmaceutical & biotech companies. As some of the candidates are nearing key R&D milestones, there is a huge competition among large pharmaceutical and biotech companies to license/acquire, these assets. The licensing of Epigen Bioscience’s EPGN696 molecule by Novo Nordisk and licensing of IONIS-AZ6-2.5-LRx molecule from Ionis Pharmaceuticals by AstraZeneca supports this trend.
As per IQ4I analysis, NASH market is expected to grow at triple digit CAGR to reach $35.2 Billion by 2026, with peak sales of 11 clinical candidates (GR-MD-02-Gilead, GFT505-Genfit, OCA-Intercpt, IVA-337-Inventiva Pharma, Aramchol-Galmed, Selonsertib-Gilead, Cenicriviroc – Allergan, IMM-124E-Immuron, MGL 3196-Madrigal, GS-0976-Gilead, Emricasan-Conatus) Owing to market attractiveness, there is huge interest by venture capitalists across the globe in providing fund to promising players. The total funding received by biotech companies focusing on NASH is worth ~$251 Mn in 2017 and it reached ~$218 Mn by the end of first half of 2018 indicating an upward funding trend in NASH research area. Some investors are even launching new companies to specifically work on NASH projects. For instance, in April-2017, Terns Pharma and In February 2017, Jecure Therapeutics was launched with investments from Lilly Asia Ventures and Versant Ventures respectively for NASH program development.
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