Theratechnologies Inc T.TH

Uphill battle in NASH for TH

[SPCEO1]

The following are comments on Egrifta in NASH from a US analyst. I would be interested to see if any among our medically competent group here would like to comment on his thoughts:

"I have seen their NAFLD data – the data is from a small trial in HIV patients with NAFLD – the MRI data is OK. True placebo in non HIV patients with NASH (not NAFLD) is like 15% which diminishes the effect there which makes me skeptical.
 
Also the question is what is the translatability of data from HIV patients with NAFLD to actual NASH patients? I don’t think we definitively know that and I am not sure they have data there.
 
Seems high risk to go straight into Ph3 NASH trial.
 
I have seen companies with better drugs and better data fail in NASH. It is a very tough space."
  
I think this is an overly harsh view of TH's data but it is nevertheless the standard view and the reason why the stock is not getting any respect for its NASH efforts. A few thoughts from a non-medical guy:

1.) MRI data - they had biopsy data so why is he focused on MRI data?

2.) I get the impression he may ahve only looked at one of Grinspoon's trials

3.) There were some NASH patients in the last Grinspoon trial if I recall cirrecctly, so it was not all NAFLD

4.) I thinnk AKRO had no placebo effect in their trial but their stock is still highly valued by Wall Street.

5.) While we don't know exactly how the data will translate from hiv to non-HIV patients, it seems fair to expect it to translate pretty well. I have to believe the tenedncy would be for Egrifta's impact to be better rather than worse on less difficult livers.

6.) While it is clearly high risk to go straight to phase III without the phase II data on non-HIV patients, can TH get a little respect for giving it a try or are we to conclude that Paul and his team are a bunch of kooks for doing so?

7.) Everyone has seen companies with better NASH data fail because, technically, TH does not have much, if any (depending on how you want to look at their data) on non-HIV NASH patients. And every drug has failed so far. So, I am not sure his last statement is worht much. I would have preferred he tell us a little more about why he thinks Egrifta is an inferior drug.

In the end, we can protest all we like but this does seem to be the prevailing view in the marketplace and is why TH is not given any value for its NASH program. Paul and his team need to understand this and provide analysts with a well-reasoned rebuttal.

[jfm1330]

Your analyst points out high placebo in non HIV, but it seems he does not take into account that HIV-NASH is likely harder to treat, so tesamorelin would be better in non HIV patients. Also, a critical aspect of the planned phase III is the 18 months of treatment. This will allow fundamental causes to be reversed to some extent, like epigenetic factors. Epigenetic is a modified gene expression

[jfm1330]

One thing to remember about NAFLD, not NASH, is that it is a pretty easy condition to reverse. I think I told that story here before, but about four years ago, after a CT-scan, my doctor told me that I had a fatty liver, in the following year, I lost 30 pounds, from 265 to 235. Then, after another CT-scan, the same doctor told me that my liver was back to normal. I am now at 230 pounds, and this

[scarlet1967]

I think you are correct it seems like he only looked at one of the trials if I recall correctly in one of previous trials they had over 900 patients nevertheless the last trial had much fewer patients but again if I recall correctly they had F2/3 NASH patients there having said that  they are planning to have some 900 patients enrolled in upcoming phase 3. As for translability from NAFLD to

[qwerty22]

red  

[SPCEO1]

Green for me - see below

[qwerty22]

I don't want to just be rubbishing the program but we have to come to some reason why the few voices we are hearing from seem to all emphasize the doubts and uncertainties around this program rather than focusing on any of its strengths. As I said I think the deeper you go into the data, the way Grinspoon has gone deeper, the more strengths you uncover. As Paul said they have lots of

[scarlet1967]

They have the backing of KOLs and FDA, seems like the EMA will be onboard as well as per the CEO based on, targeted proteomic, transcriptomic approach, organic approach which works upstream by stimulating the pituitary glands to produce normal timed secretion of growth hormone which directly reduces visceral fat, decreases lipogenesis, decreases triglyceride accumulation, decreases oxidative

[Wino115]

Good discussion and I don't have much to add as you all covered it. It does sound like it would be highly worthwhile for the company to define in the protocol an interim read on some of the various markets, without having to do a biopsy.  Between MRI-PDFF (which Loomba advocates) and other blood markers, etc... they could provide a reasonable proximity to Phase 2B type data for drug and

[scarlet1967]

Oncology will be if successful the first catalyst for the stock, we should have some safety and probably preliminary efficacy results soo but I believe they should keep the NASH relevant for eventualities... I think as you said to add interim bio markers  read out to NASH would also be a great idea for many reasons...

[scarlet1967]

And yes sales of the legacy drugs, I get it the programs if and when showing  progresses are the main value drivers but the company isn't in control of those programs successes or failures. The way I see it the new marketing strategies of drugs reaching directly to their targeted patients/doctors using electronic communication for instance advertising in patient electronic journals/apps,

[qwerty22]

Is this just a personal comment you got from somebody you know or is it part of a public statement by somebody?

[SPCEO1]

Another large shareholder had an e-mail exchange with a NASH analyst (they are both at the same brokerage firm) and he passed the analysts comments on to me.