Theratechnologies Inc T.TH

Alternate Symbol(s): THTX

Healthcare Biotechnology

Theratechnologies Inc. is a Canada-based clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of therapies addressing unmet medical needs. It markets prescription products for people with human immunodeficiency viruses (HIV) in the United States. The Company's research pipeline focuses on specialized therapies addressing unmet medical needs in HIV, nonalcoholic steatohepatitis (NASH) and oncology. Its medicines include Trogarzo and EGRIFTA SV (tesamorelin for injection). Trogarzo (ibalizumab-uiyk) injection is a long-acting monoclonal antibody which binds to domain 2 of the CD4 T cell receptors. It blocks viral entry into host cells while preserving normal immunologic function. The Company is also investigating an intramuscular method of administration of Trogarzo. EGRIFTA SV (tesamorelin for injection) is approved in the United States for the reduction of excess abdominal fat in people with HIV who have lipodystrophy.

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Theratechnologies Inc > Intercept slips due SAFETY of Ocaliva

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Comment by qwerty22on Oct 09, 2020 4:28pm

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Post# 31697991

RE:RE:RE:RE:RE:RE:Intercept slips due SAFETY of Ocaliva

It's a 2ndary analysis of the Lipo Ph3 patients looking at liver enzyme.

Maybe I should look this up but what is the mechanism behind raised ALT/AST. Is that just dead/damaged hepatocytes releasing the enzymes?

scarlet1967 wrote:

https://pubmed.ncbi.nlm.nih.gov/28832410/

Wino115 wrote: Two questions for you (or others).
1. What 800 patient study was done on tesamorelin? Is that the one where Takara Stanley went back and followed up on a hundreds of past users and got various readings. I'm guessing that's the one you're referring to.

2. Does anyone have thoughts on what the Akero guys are daying about their drugs MOA stoping both lipolysis and lipogenesis? Just wondering where the fat busters fit in on the latter and what we've heard about lipogenesis with tesamorelin or any fat-buster.

scarlet1967 wrote: "The anti-fibrotics have really faded bigtime", I think you might have a good point there both in the conference and in the investor presentation they are trying to link the reduction of liver fat to reduction of inflammation/fibrosis.
For instance GH decreases reactive oxygen species (causing cell death) inducing mitochondrial function thus less inflammation AND fibrosis, study done on 800 patients over 12 months treated by tesamorelin resulted in significant reductions of transaminases responsible for liver fat AND fibrosis, Loomba's study linking a reduction of 30% liver fat with reduction of fibrosis (more than 52% of patients treated with tesamorelin had more than 30% of liver fat)...

quote=qwerty22]
There is research that can shed light on safety versus efficacy, I read a while ago. My memory is that of trials that fail/stop a small percentage stop for 'commercial' reasons. Of the rest about 1/3 fail because of safety at Ph3 and 2/3 fail for efficacy. As you say safety more commonly comes to light earlier but it's still a big risk at Ph3.

I did my own personal wonky logic calculation that tried to balance my perception of the present shortfalls in efficacy against the hugely reduced safety risk when it comes to trying to assign risk to any Theratech Ph3 program. I tend to think you can easily counterbalance any increased risk from efficacy failure against the reduced risk from safety failure.

Wino115 wrote: This highlights a significant benefit that THTX has and should pitch like heck in their books, and that is SAFETY. I don't know what the appropriate weight of safety versus efficacy should be in analyzing the progression of a drug through trials, but it seems in NASH they have been sort of equal in all the various failed trials. Gilead's ASK1 inhibitor had no efficacy, same for Genfit's PPAR and a few others (Takeda/Shire, Conatus, etc...). Safey's hit back a few others too along with Intercepts FXR, but it usually hits the trials earlier in Phase 1's and 2's. As I said yesterday, Akero's really not yet gotten over the safety hurdle on their great numbers, but it still could in the next trial.

If we assume it's a 50/50 safety/efficacy split in the risk of failing a Phase 3, then THTX should absolutely be full throtle highlighting they are past that as the drug has a 10 year track record with nothing. That is really worth a lot in terms of discounted market cap and valuation. Just mathematically it is, with no argument.

So you can say that all THTX is left with in this Phase 3 is efficacy. They need to really lay out everything they have as far as efficacy. They've got the pieces of the puzzle there, but have yet to really put it all together in a powerfully convincing way, like what Qwerty laid out the other day. But it really should be easy for them to do that. They really do have many of those pieces and have large studies from KOLs that support the basis of their case around the loose ends. It's never 100% for any of these drugs until you finish Phase 3, but they have every reason to be as hopeful about the MOA of tesamorelin as any of these guys have for their approaches. And at this point, the furthest along NASH treatments are all now the "fat-buster" approaches and they are one of those now. The anti-fibrotics have really faded bigtime.

This likely spells the end to all the bile acid approaches. I think they're laying off 20% of workforce too.

scarlet1967 wrote: "
They seem to have major safety issue with their drug and significant negative cash flow!(cash burn between 60 to 70 M per quarter)
ICPT market cap 1,25 B VS THTX 172 M??