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Today , as Intercept a few week ago , GENFIT announced delay in their patients recruitment.

The NASH trials are all impacted by the complexity of recruitment. Today, Genfit also announced a delay needed to fully recruit their F2-F3 NASH patients in RESOLV'IT.

The problem was the same for Intercepts who announced, a few weeks ago, their incapacity to recruit the planned number of patients in REGENERATE and decided to reduce its drastiquely ( from 1400 to 750). Il is a risky bet because they will impact the strengh of their study results.  Genfit choose another way, they prefer to delay the recruitment ( 4 to 6 months) but preserve the future strength of theirs trial results.

We also noticed the recruitment problems of GALMED, one year late, and CONATUS.

The main problem is the huge number of clinical trial launched on NASH in the last 3 years and the difficulty to diagnose the disease.

NASH is not easily diagnosed, currently, the only way to reliably diagnose NASH is by histological analysis of a liver biopsy. A biopsy is not a benign act, it carries a risk and can be painful. Further more, it is not a large scale diagnostic tool but a surgical act prescribed (and accepted) only when many other clinical factors indicate a serious liver problem. 

Regarding this, one can understand why the number of diagnosed patients is limited. Recruitment criteria also require to comply with many other parameters which reduce also the  trial compatible number of patients.

This seems paradoxal for a disease supposed to impact million of patients in the world, but it is the main specificity of NASH, an huge lack of diagnosis.

Some Labs decided to improve their recruitment by exluding biopsy and relying on imagery, but as it is not the consensual gold standard, their trials are not considered as very reliable.

The challenge is complex, Labs need to improve quikly the knowledge of the disease by all the healthcare chain to promote diagnosis. 

The delay are the same for all actors and could also delay the potential access to the market of drugs. it is not a good news for patients nor for the biotechs targeting NASH.

regarding this delay some biotechs targeting NASH could face a cash problem in a close future, as INTERCEPT and GALMED. GENFIT cash seems in a better shape and could permit the Lab to reach their Ph3 results alone. 

Big labs as Novartis, Gilead or Allergan are not impacted by the cash problem and they could use this mess to launch an raid on the weakest.

The main problem of NASH treatment market is still the time neaded to educates physicians and patients on the disease. 

Regarding that point, a little more time before arriving in the market could be beneficial to labs and not impact too much the future turnover, that will grows faster in a more educated market.

G. Divry

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