Theratechnologies Inc T.TH

Credit Suisse event now available

[palinc2000]

Under event tab at Thtx website

[qwerty22]

So it's pretty clear now that the part1 protocol is different to the way they previously presented it (Scarlett was bang on). So enrolment numbers are still very low. I think I'm a little more comfortable about there being no efficacy signal so far. Once you combine the low patient numbers, all-comers, low doses and super sick people then it's perfectly acceptable to not have a signal

[SPCEO1]

I asked a second question yesterday trying to get more insight into the patients treated, etc., but that was not asked. I wish it had been as Paul said he knew investors were interested in this but I came away more confused about that as he never squared up what had been communicated previously and what was in the new chart. I suspect if the question had been asked, he would have given us more

[jeffm34]

Why aren't they going after the NASH market in the HIV population right now. They should be out there talking to physicians and direct to patient marketing showing that treating the lipodystrophy can prevent NASH. Yes there are some legalities with what can be said but there are still ways to do it. 

[scarlet1967]

  https://www.clinicaloptions.com/hiv/programs/2021/hiv-and-nash/podcast  

[jeffm34]

Exactly! Why waste 6 years and $100M or so chasing NASH in the general population when you could be focusing that money and effort on a significant NASH market with an already approved drug. 

[palinc2000]

The inial request to FDA was to initiate a Phase 3 tril in Nash exclusively  for PLWH and  that was obviously rejected by FDA and subsequently THTX announced that it was going for the General Nash population

[scarlet1967]

The HIV market is much smaller and I am not sure how much cheaper or smaller that trial would be? I also think the company wants operations  outside the HIV market. Approximately 1.2 million people in the U.S. have HIV. About 13 percent of them don’t know it and need testing. HIV continues to have a disproportionate impact on certain populations, particularly racial and ethnic

[jeffm34]

There is no trial needed to sell into that market right now!  Every person with HIV who is at risk for NASH will have lipodystrophy. Egrifta is already indicated for that. You just have to convince the physicians and patients that by treating the lipodystrophy you can prevent NASH 

[jeffm34]

If THTX can't convince physicians to prescribe egrifta now to treat and prevent NASH in their HIV patients. (which they could be doing) why would you expect them to do any better in the general population? 

[SPCEO1]

Actually, it is illegal for them to sell Egrifta that way (in a manner it is not approved for). So, while what you are saying is something they no doubt wish they could do (and the patietn would indeed benefit), they can only do so obtusely and that tends not to be very effective.

[jeffm34]

It's really not that difficult of a concept to understand but I will explain it again. They are treating the lipodystrophy which it is indicated for.  One of the added benefits is that it will likely prevent NASH. There is absolutely nothing illegal about doing that. It's not even off label use which they could do anyways if they chose to. 

[qwerty22]

That is illegal. You can't tout the drug as treating NASH. Maybe you can point a doctor to Grinspoon's work and allow them to draw their own conclusions but you can't sell that idea. You also can't expect doctor to necessarily draw these conclusion independently. Treatment has guidelines and doctor follow the professional standards. I think they can only approach this tangentially.

[qwerty22]

If you click the podcast link you'll hear the advise and see it's funded by a thtx educational grant.

[jeffm34]

What aren't you understanding? I'll get out my crayons and draw you a picture. You are touting the drug to treat lipodystropy. That's it!!!!  The fact that it may prevent NASH is secondary to the issue. 

[qwerty22]

How does the doctor know the NASH effect exists?

[palinc2000]

Is it not a fact that if you have Lipo your risk of getting Nash is higher than in the general population? Are all the studies which all point in the same direction not a big enough enticement to get vtreated for Lipo? What have you got to lose?

[Wino115]

All I would say is they did a huge shift from sales people to MSLs back when EGRIFTA SV came out just for that purpose and we have not seen a very large pick up in demand yet.  They've been trying to do exactly what you say for 2.5 years now.   You may recall I once did a little exercise and came up with the fact that 100 new Lipo/NAFLD patients would equate to $.10 in EPS and if

[palinc2000]

You were not dead wrong....!!!! They just did not execute 

[palinc2000]

THTX cannot change the label for Egrifta which adresses exclusively Lipodystrophy  . But i there are many studies indicatiing that Lipo can be a precursor for Nash.....So why dont physicians use that argument for all Lipo patients .....they can say that this link  iis not yet proven but what what have they got to lose......nothing illegal 

[jfm1330]

I listened to the presentation. Nothing really new on the fundamentals. To me it is clear that they are on the right path and there are no red flags at this point. It is also clear that the strategy is to say the minimum about what is going on in the trial. A simple example of that is the answer to the question about the level of free docetaxel in the bloodstream after injection of TH1902

[jfm1330]

I meant pharmacokinetic data.

[qwerty22]

Like SPCEO I think they could have gone more data orientated on this. It is an important factor and if what they've seen so far is good news they could have dropped a provisional headline number on the low level of peak degradation. The real problem is are still at half a dozen or so dosed patients. It's a roll of the dice in each patient to get an efficacy signal and we haven't hit

[Wino115]

In reviewing the slides again, I see my error.  It's a Grade 4 Neutropenia (which is not good), but it was not severe because it was non-febrile.  So a non-febrile Grade 4 Neutropenia is only a Grade 2 TOXICITY.  I missed that the Grade 2 referred to just the TOXICITY ranking which is only applicable to the dosage trial looking for levels of Dose Limiting Toxicity, and I guess a

[Wino115]

Reading up a bit, it appears a Grade 4 neutropenia without a fever and observed for less than 7 days is not a DLT event.  So that's why it's rated lower as on the DLT scale.  Must have been less than 7 days and not life-threatening in any way. On the trial schematics changing, I always assumed those were sort of the upfront planned case but wholy subject to change as unknown

[qwerty22]

I think what happens is at 300 you enrol a patient (let's say the guinea pig). If that patient is good then everybody who is still on study moves up to that dose. This is how patients enrolled earlier stay on the drug by following the first dose patients. These followers don't count toward DLTs because only patients receiving their first dose at that level count toward DLT. So if we went

[SPCEO1]

I am pretty sure that if they hit enough DLT's the trial stops and the MTD is the previous dosage level. So, there is a chance the trial stops quite soon if the patients getting to the 420 level have side-effects that are serious. If so, we may hear about the trial's results before the end of this year. If we do not hear, then we know the one incident at the 420 level was a one-off event

[scarlet1967]

We did hope there would be better sale numbers due to dual effect of Egrifta but it is based on clinical trials which are not approved so there are obviously some hesitation there but if their drug get approved for general population for an unmet serious condition there won't be a need to convince doctors and patients as that would no other options even so others drugs get approved before

[juniper88]

I came up with some ideas why there might not be any efficacy signals.  Please let me know it this makes any sense, and feel free to poke any holes in my logic. 1) There have been no high sortilin expressing patients so far. (seems unlikely as sortilin is more expressed as the disease progresses.) 2) TH1902 does not enter into the sortilin expressed cells.  This could be because

[Bucknelly21]

Pretty clear at this point they have no capacity to interact with the market in the "modern way" this explains all our issue with the company at this point. The issue is you can hire all the senior ir people you want but if the people making the decisions are unwilling to change then it will be this way for a while 

[qwerty22]

From what's on p18 and p19 I'm going with only six patients having been dosed with the drug so far, going on the basis that the last patient dosed was the first 420mg patient. We know the first enrolled guy unfortunately died. For much of the time patients have been dosed with less than the recommended dose of docetaxel. I don't think if those are the correct numbers that I'm