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What is NASH and which biotech firms are vying for the first-mover status

NASH, or Nonalcoholic steatohepatitis, is undeniably a golden goose in the pharma space. The biggest corporate attraction towards this liver disorder is the fact that there are currently no treatments available in the market, and therefore, whoever manages a breakthrough in the clinical trials would grab the first-mover advantage.

It also nullifies the requirement during phase 3 trials to prove that the investigational drug is more effective than the one that is currently available in the market.

Image for representation (Photo by Drew Hays on Unsplash)

According to ResearchAndMarkets.com, NASH’s market value is set to increase to $21.5 billion by 2025, compared to just over $1.1 billion in 2017.

What is NASH?

NASH is a type of Nonalcoholic fatty liver disease (NAFLD), usually caused by an unhealthy lifestyle, heavy alcohol intake or obesity, which damages the liver and causes inflammation due to a high buildup of fat. It can also lead to liver cell damage or cirrhosis.

Though the disorder shows no symptoms initially, in the later stages, a patient may experience fatigue and belly ache.

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Clinical trials and drug candidates

Though the testing conducted by different laboratories follow various designs and methods, the US Food and Drug Administration (FDA) has set the primary endpoint for Phase 2b or Phase 3 treatments as reversion of NASH fibrosis, according to NASH Biotechs.

Allergan (AGN), Gilead Sciences (GILD), French biopharmaceutical company GENFIT and Intercept Pharmaceuticals (ICPT) were among the first companies to gain a breakthrough in the clinical trials, to reach Phase 3.

With Gilead taking a hit in early February by failing to meet the primary endpoint of its most advanced NASH candidate, selonsertib, in a Phase 3 trial, it may be said that Intercept is leading the race at the moment. A week after Gilead’s failed trial, Intercept announced positive topline results from the phase 3 study of its NASH candidate Ocaliva, sending the stock up 25%. The company added that it intends to file for approval in the U.S. and Europe in the latter half of 2019.

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However, investors continue to be brutal towards biopharma companies. The stock tumbled the next day on investor concerns over any troubling side-effects, besides the failure to meet one trial endpoint.

Meanwhile, French company Genfit has been studying the scope for combos to treat NASH and is expected to deliver top-line data from the Phase 3 trial for its elafibrano late this year. Genfit could be the next-in-line for the first-mover status if Intercept fails to please the FDA. Genfit last week launched a global offering of its American Depository Shares and ordinary shares to raise around $132 million. The company intends to list as “GNFT” on the Nasdaq Global Market.

Allergan’s immune modulator drug candidate Cenicriviroc, which is currently in phase 3, is also showing a lot of prospects for its anti-fibrotic effects. But the top line data is now expected to be out only by the fourth quarter of 2020, which gives adequate time for rival firms to catch up.

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Norcross, Georgia-based small cap clinical-stage biopharma firm Galectin Therapeutics (GALT) had recently announced rights offering to fund the Phase 3 trials for its candidate belapectin. The fallout of bigger firm Gilead has now opened up lots of growth opportunities to smaller firms like Galectin.

Besides these, over 30 companies are in the fray in phase 2, hoping to beat the rivals who have already gained a head start. The companies that are most advanced in Phase 2 trials include Madrigal Pharmaceuticals (MDGL), Australian firm Immuron and Galmed Pharmaceuticals (GLMD).

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