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. 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.

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Theratechnologies Inc > PLWH and Nash

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Comment by Lee430on Mar 15, 2024 1:58pm

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Post# 35935350

RE:RE:RE:RE: PLWH and Nash

Palinc2000, it seems that we interpreted the FDA push for Thera to trial the general population & not just PLWH as a positive indication of support, however, in hindsight it seems to have been a disaster for the program as it is possible we could have been approved by now for the HIV population if we were not pushed down the wrong rabbit hole.

Is this that way you see it also?

Qwerty54321 wrote:
I can't see any restrictions. The exclusion was to keep the trial as simple as possible. Most drug trials do that. Hiv patients aren't then excluded from those drugs.

palinc2000 wrote:
If HIV patients are diagnosed for Nash they would not be prescribed the Madrigal drug?

scarlet1967 wrote:
Exclusion criteria

Patients who meet any of the following criteria will be excluded from participation in the study...."

Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, who are known to be positive for HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections."

https://www.nature.com/articles/s41591-023-02603-1

I don't believe they had any HIV positive patients enrolled in their trial like most of the current trials.

palinc2000 wrote: We were told a few years ago that FDA insisted that THTX proposed Phase 3 trial include the general Nash population and not only PLWH .....In hindsight that was bad news since THTX could not handle such a large trial

Does anyone have access if any to the subset data from the Madrigal trial on results in theur Phase 3 trial for PLWH?
Scarlett and or Qwerty are the only posters imo on this MB who could find out but of course others are invited also
Maybe just maybe there could be an opportunity for going back to the original Nash protocol to include only PLWH