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 > Completely unprepared for this outcome

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Comment by scarlet1967on Dec 16, 2022 9:37am

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Post# 35175427

RE:RE:RE:RE:RE:Completely unprepared for this outcome

The issue is we can only speculate but Paul did mentione during last CC many companies change the trial design in manny many ways, they did also mentioned in the IP exploring the idea of shorter dosing interval and few hours after the paus the decision was made to make that amendment. To me it looks like this option (plan b)was on their mind based on their findings preclinical/clinical and not pure guessing now they have hired someone with experience from working with a CRO. Point is unfortunately the perception is the protocol is a failure but to me it seems this adjustment has been considered and analyzed for a while and a CC could change that perception. I realize it is still early in the process and the trial can fail at any time even with the amendment but often folks are talking about lost credibility/trust issues etc the best way to regain the credibility is clear and transparent information sharing in timely manner in my opinion!

Wino115 wrote: They've always mentioned the possibility that if sort1 is doing it's thing to internalize most of the PDC right in the tumor and bypassing resistance in a safe way, they could play around with the "window" opportunities. Worth asking in next call if part of their ongoing lab work was doing that. Have to figure the lab guys are doing it now though to get them some info. No doubt, all the pre-clinical looked very logical and ticked all the boxes, the FDA even agreed. Translating that into clinics is their test.

scarlet1967 wrote:
ca39cc52-e553-4a81-9b8d-a217ad2558cc

ca39cc52-e553-4a81-9b8d-a217ad2558cc

“Explore different dosing schedules (weekly, intermittent vs continual) in order to increase the therapeutic window in terms of efficacy and safety.”

Again they didn’t make a decision of that magnitude particularly for a small business which has to allocate their limited resources wisely in matter of hours so they did start and should have the started figuring their contingency plan during the course of the trial based on their observations.

I personally would applaud them if they had shared as much as they could showing that this company is prepared for the eventual challenges instead they decided …..