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Theratechnologies Inc T.TH

Alternate Symbol(s):  THTX

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. 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. Its portfolio includes Phase I clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate (PDC), in patients with advanced ovarian cancer.


TSX:TH - Post by User

Post by SPCEO1on May 27, 2021 10:50am
101 Views
Post# 33275320

This comment from LTF ay be of interest re: NGM

This comment from LTF ay be of interest re: NGMGood Morning Everyone, I want to chat a little bit about NGM. First, the two histological endpoints for pivotal Phase 3 NASH trials are- histological NASH resolution without worsening of liver fibrosis or histological improvement in liver fibrosis without worsening of NASH. Aldafermin was successful in the former endpoint but not the latter. The incovenient NASH truth is that NGM fell into the greed trap-this term denotes biiotech trying to achieve the more lucrative endpoint irrespective of what their investigative therapy is designed to do. Mechanistically, resmetirom/MDGL and aldafermin are similar in the sense that they are designed to alleviate fat accumulation with subsequent histological NASH resolution and "some" improvement in liver fibrosis. MDGL has consistently maintained histological NASH resolution as its primary endpoint-that remains the case for the pivotal Phase 3 trial in progress. So why did NGM deviate from an endpoint that is more feasible to mechanism of aldafermin to that which is not???? I don't have any specific answer to that question but it sounds like the greed trap. On release of the data, the usual culprits were blamed---the NASH patients. Based on FDA guidelines, this was a succsessful trial. I am left to ponder whether NGM proposed liver fibrosis to the FDA as the primary endpoint during the design of the trial ???--This is a logical conclusion which explains the abrupt discontinuation of aldafermin for NASH F2/F3 fibrosis. Look at column 4 and row 2 in first table denoting histological NASH resolution. Next, table 2-column 4 and row 1 on the robust liver fat reduction by aldafermin. You all know by now that I am not a fan of short treatment duration of 24 weeks ot less. An ideal treatment duration for NASH study should be 36 weeks and up. FYI, AKRO has followed the foodsteps of NGM/aldafermin-we know how that it will end unless revisions are made. In the absence of unforeseen error or safety signal-MDGL has the sizeable lucrative NASH therapeutics market on approval. This is where we are based on current events.

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