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In recent weeks, the race to the NASH treatment market  has been the theater of many movements, the purpose of this article is to make an inventory of these changes and their possible consequences.

The interests from the health agencies on NASH is still high, in February CONATUS and NIMBUS got a FASTTRACK status from the FDA for their drug candidates targeting NASH.

TOBIRA announced that they intent to report top-line Year 1 primary endpoint data in the third quarter of 2016. Nevertheless they need to complete the Year 2 primary endpoint data to publish the entiere results of their Phase 2b trial. we can expect full results at the end of 2017 maybe at the beginning of 2018.

GENFIT  had their Phase 2b (GOLDEN) trial results published in Gastroenterology. 

Despite an initial misfit on the first results regarding the excessive reversion of placebo patients with little advanced disease, the results published on patients with more advanced disease  are very good and prove a direct action on NASH reversion. Moreover, the safety profile and cardioprotective effects are confirmed. The action on glycemic parameters is also very positive.

GENFIT published the design of their Phase 3 (RESOLV IT) and announced just after, the recruitment of their first patients.

INTERCEPT PHARMACEUTICAL is completing from time to time the list of the centers involved in their Phase 3 but no announcement on a first recruitment was done yet.

In the same time the advisory meeting organized by the FDA to evaluate the relevance of an accelerated agreement for OCA in PCB voted positively. Nevertheless the data published revealed notables liver adverse events with OCA at high dose and the FDA proposed to limit the OCA dose at 10 mg/day. This dose seems efficient on ALP reduction as a predictive surrogate parameter on PBC but it seems too low for an direct effect on NASH ( as seen in Japan). The REGENERATE trial will give us more information on that point.

At the same time GALMED seems to be late in his Phase 2b recruitment.

GILEAD announces the acquisition of the NIMBUS NASH program for 400M$ and up to 800 M$ of milestone payments. But just a week later, a report revealed by Bloomberg explain that the half life of the NIMBUS drug is very short and do not exceed 10H for the highest doses, which could imply multiple doses per day for the treatment, and concluded that it is not a good configuration  for a market agreement by the agencies.

To date, we can only note that the leader position of GENFIT in the treatment race, both in scientific and schedule terms, is not included in the company's valuation which expose the company to a possible hostile raid.

On the diagnosis front a lot of announces and evolutions  occurred.

OWL confirmed the availability of their OWLiver Test on NAFLD based on metabolomics

Talemnology confirmed also the availability of their DeMili NASH test based on MRI 

GENFIT also presented their diagnosis biomarkers based on mRNA.

SUPERSONIC IMAGINE presented their ultrasound technique named Air Explorer which allow to diagnose liver Fibrosis in a very short time.

All those announce is the proof of the interest of scientists in NASH diagnosis to fullfill an unmet urgent need.


The two laboratories (ICPT and GNFT) leading the race conserve their advance and could be on the market two years before their followers. 

GENFIT with a better safety profile and its cardiometabolic protection is the potential winner of the race at this time.  

INTERCEPT confirmed that the first part of their recruitment should be completed in the first semestre of 2017, as GENFIT annonced the same for the first quarter of 2017.  If their planning is respected, it confirm that GENFIT lead the race. 

Simultaneously, the diagnosis techniques for NASH are emerging and progressing very fast, this could increase dramatically the size of the potential market of the disease treatment as soon the first agreements of drugs in 2019 and in the following years.


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