scarlet1967 wrote:
Just had a quick look!
Theratechnologies: Clinically Poised for High Growth Opportunities
Oncology:
Phase 1/Part B dose established at 300 mg/m2 or 1.5 times the therapeutic dose of docetaxel alone.
• No dose limiting toxicities were observed following the completion of the first cycle in the last 6 patients treated at 300 mg/m2.
• Expansion study will evaluate TH1902 as a monotherapy in solid tumors with high expression of Sortilin receptor, including Hormone Receptor-positive (HR+) Breast Cancer, Triple Negative Breast Cancer, Ovarian Cancer, Endometrial Cancer, and Melanoma with approximately 10 patients per tumor type.
• One arm will include a mix of tumor types including Thyroid, Small Cell Lung, Prostate and potential other high Sortilin expressing cancers with approximately 15 patients in total. In addition to evaluating the anti-tumor activity of TH1902, the study will continue to evaluate the safety and pharmacokinetics of TH1902.
NASH:
Discussions with FDA and EMA are complete
• Phase 3 clinical trial design finalized
• Amended trial design includes a Phase 2b/3 seamless study design where the first 350 patients’ data will be analyzed by a data monitoring committee to inform a go/no-go decision to continue the study
• In parallel, exploring other non-dilutive financing options and partnerships prior to trial initiation
Egrifta:
Specificity: unique mechanism of action that regulates GH secretion
Maintained Efficacy: results shown at week 26 and maintained at week 52 with 27%
decrease in visceral abdominal fat
Simplicity: a single vial with a small volume of injection storable at room temperature o Medical Benefit: left untreated, excess visceral abdominal fat is linked to potential
severe health consequences that could lead to an increase risk in mortality
• EGRIFTA SV® is expected to drive increased patient compliance
• Well-established safety profile as evidenced by 10+ years of commercial availability with a high degree of tolerability
Trogarzo:
RegulatoryexclusivityintheU.S.untilMarch2030
sBLAforIVpushmodeofadministrationofTrogarzo®filedwithFDA; Initiation of patient enrollment for Trogarzo® IM study
https://www.theratech.com/static-files/c47acbbe-031e-46fe-a873-bc7cfb97e92f