One good TERN-101 deserves another, comments about a NASH clinical trial

There has been a lot of disappointing news about NAFLD/NASH therapy research this past year.  I thought you might enjoy a look at some new data that is very encouraging. Terns Pharmaceutical just reported very positive 12 week results of the drug TERN-101. Below is a chart from their report about changes in results using a fairly new non-invasive test by Perspectum, the Liver MultiScan measuring a value called cT1 or corrected T1.  I'll explain it a bit later but for the moment just know that it is an indirect measure of fibrosis.  Click the image to see a larger view.  As a phase 2 study this is a small number of patients but the effect on their livers in only 12 weeks is among the best early data that we have seen.

A reduction in cT1 is not a measurement most patients know about  The test was developed by Perspectum Diagnostics in England and it has been used successfully there for a while now.  It is a key tool of the UK BioBank which is creating a database of 500,000 people for medical research. It is being used by drug researchers but getting through agencies like FDA and CMS is a slow process so it hasn't been available to most of us.  Once fully approved, methods like this will largely replace the biopsy so we are very pleased to see studies reporting results using MultiScan. This little graphic can give you a sense of the test. Click it for a bigger view.

At this point you might want to say "OK smarty pants, what does that mean to me as a NASH patient". Just stick with me a little bit longer. Look at this chart.

I know, more confusing medical jargon. What this shows is that patients with cT1 scores of less than 825 had far fewer liver related complications over the years. If you look back at the first figure you can see that the Terns drug reduced the cT1 score by over 70 points at the highest dose and they had no serious side effects (not even itching) and did it in only 12 weeks. If you would like to see the entire Terns presentation HERE IS A LINK TO THAT SLIDE DECK.

Remember, this is just a phase 2a study.  Terns still has to go through a big phase 3 and a bunch of other hoops before we could see this as a drug but whether it succeeds or not it is more evidence that it will be possible to treat this disease.  Lifestyle will always be our first, best strategy but when that fails we will have effective therapy. Your job, is to stay alive until we can get there. It is still diet and exercise but for most of us, who have no chance of a transplant, this promises another road will be available one day.

Our best to you and yours and may the vax be with you.

 


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