In these troubled times when the world is holding its breath, I wanted to give a brief update on the impact of the COVID 19 pandemic on the NASH world.

There is no doubt that the health emergency and the containment decisions made in many countries are having a major impact on the response times of health agencies, which understandably have seen their priorities change and have allocated the majority of their resources to help populations and states find appropriate responses to this pandemic.

This is impacting the response or review times of these agencies for administrative marketing authorization applications.

In addition, the impact of the confinement and embolization of healthcare systems does not allow clinical studies to be conducted without any problems, nor does it allow new patients to be recruited.

As a result, many companies have announced the suspension, discontinuation or postponement of their clinical studies in NASH.

For the most advanced studies, such as those of INTERCEPT and GENFIT, this delay has been acknowledged by press releases.

The committee's review of the relevance of OCALIVA (INTERCEPT) as a treatment for NASH-related Fibrosis, which had already been postponed twice, will only be able to take place in June 2020, which postpones the eventual marketing authorisation by a minimum of 3 months, plus a reasonable 6 months to my opinion. Their CEO remains convinced that they will be able to launch the commercialization of OCALIVA in NASH in June, I find him more than optimistic.

GENFIT, which had delayed the publication of interim results from its RESOLV'IT Phase 3 study pending FDA comments on the addition of Metabolic Endpoints to the study design, has received the expected elements from the FDA on schedule (end of March) but the implementation of statistical and pre-control procedures for the lifting of the double blind induced by these design changes are slowed by the containment and will take a few weeks longer than expected. The expected publication in mid-April will therefore probably take place at the end of May. In addition, the ancillary clinical studies necessary for the submission of the marketing authorisation application are being postponed, which will delay the submission of this application by one to two quarters.

Curiously, MADRIGAL does not communicate on the impact of the pandemic on its ongoing studies, and their website still announces their presence at the EASL International Liver Congress 2020 in London in April 2020 when it was postponed.  I have no doubt that the impact on their ongoing clinical studies is equivalent to its competitors, they simply have not decided to inform their shareholders about it to date.

As we can see, the impact of the pandemic is far from negligible by postponing the expected announcements by several months. However, we can take solace in the fact that publishing major announcements in the midst of a pandemic would not be very timely and would risk going completely unnoticed. Perhaps these delays will allow good news to get out when the pressure on the media has subsided and when we all need it.

G Divry

Notice that I am neither a physician nor a biologist, my point of view is only that of an enlightened amateur, so it must be taken for what it is, a questionable point of view!

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