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 > Any-news about the meeting?

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Comment by jfm1330on Oct 29, 2020 8:58pm

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Post# 31810703

RE:RE:RE:RE:RE:Any-news about the meeting?

I listen to the part where Paul and Christian were talking, then were cut because of time limit. I did not listen before and after. Nothing new there for me. That being said, Levesque put the case quite clearly. They want to go forward in phase III because they have an approved drug in a similar indication that is now know to be safe long term. After that, on the efficacy front, yes they have not a lot of data in real NASH patients, but what they saw in these HIV-NASH patients is enough because HIV-NASH are harder to treat patients. They also saw in all the trials, including those on lipodystrophy, the lipolytic effect of the drug. Finally, the last piece is the transcriptome analyses that were done on patients before and after treatment and to put the odds as much as possible on their side they decided to extend the treatment period in the trial to 18 months to be sure to see the maximal effect of the drug. So this is the case they will make to the FDA. The key is to have it presented as well as possible covering all the angles as much as possible. As I wrote here many time, the key to go directly to phase III is the fact that tesamorelin has proven long term safety ans that there is an unmet medical need with urgency to treat for thousands of patients. With all that it will be up to the FDA and EMA to decide. Tesamorelin cannot be treat as a new drug with no long term . track record on safety for a chronic indication. Patients will need to take NASH drugs for many years, even more than a decade. The logic is to give the phase III green light to the proven safe drug, even though it needs to take the unusual road to approval.

SPCEO1 wrote: I will defer to Qwerty, JFM and others with a deep medical understanding to amke comments about it. IT is not over yet but I thought Paul and Christian made the points they wanted to make. But they made too many points about Lipo, Trogarzo and cancer and that was wasting the time of the listeners as this is a NASH program. But I understand they are trying to introduce the whole company to the listeners - I just don't think it was needed or certainly could have been shortened considerably.

Adonis wrote: Any-news ??