They applied got approved and announced it some few weeks later last time for both projects. Of some reason the company doesn't think timely delivery of information isn't necessary. Maybe last time they tried to release good news just before the offering few days later but overall their communication regarding material information has been the bare minimum and not as frequent as it should. Sometimes one has to wonder...
R&D UPDATE
Tesamorelin for the Treatment of NASH
In November 2020, Theratechnologies filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) for the Phase 3 development of tesamorelin for the treatment of adults with Nonalcoholic Steatohepatitis (NASH) with liver fibrosis. The Company announced today that it has received a “Study May Proceed” letter from the FDA for the Phase 3 trial with a recommendation that the Company requests a meeting to discuss questions and comments received on certain aspects of the proposed trial design, to ensure alignment with the agency’s expectations with NASH trials. The Company intends to follow up on the FDA’s recommendation and will formally request a meeting with the agency.
The proposed Phase 3 trial design will enroll participants with liver-biopsy confirmed NASH and stage 2 or 3 fibrosis. Participants will be randomized 1:1 to receive 2 mg of tesamorelin or placebo. A second liver biopsy will be performed after 18 months of treatment for the first 900 participants, approximately. These data will form the basis for filing a supplemental Biologics License Application (sBLA) with the FDA to seek accelerated approval.
The primary endpoint used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared to placebo.
Participants will remain in the Phase 3 trial for a total of 60 months. Approximately 2,000 participants in total are expected to be enrolled including a cohort of approximately 75 to 100 participants with HIV.
Theratechnologies’ goal is to initiate the Phase 3 trial by the end of the third quarter of calendar year 2021. The final timing of the trial initiation is dependent upon any adjustments to the protocol and trial design as recommended by the FDA and European agencies. Any changes to the trial design or expected timelines based on discussions with the FDA will be disclosed thereafter.
SORT1+ Technology™ in Oncology
In December 2020, the Company filed an IND application with the FDA for the development of TH1902, its lead peptide-drug conjugate (PDC) (docetaxel conjugate) derived from its SORT1+ Technology™ platform, for the treatment of various cancers. The IND application was based on preclinical data obtained in endometrial, ovarian, colorectal, pancreatic, and triple-negative breast (TNBC) cancers.
Theratechnologies announced today that it has received a “Study May Proceed” letter from the FDA for the Phase 1 trial. The proposed Phase 1 trial design includes a dose-escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies. Once the MTD is determined, a total of 40 additional patients will be enrolled to evaluate the potential anti-tumor activity of TH1902 in patients with endometrial, ovarian, colorectal, TNBC and pancreatic cancer. The Phase 1 trial is expected to be initiated in the second quarter of calendar year 2021 and is designed to identify a recommended dose for Phase 2 development. The preclinical evaluation of TH1902 in melanoma is ongoing.
“I am extremely pleased with the efforts of our teams to achieve these two remarkable milestones that will provide tremendous opportunity for the Company. Theratechnologies is in an enviable position with growing sales and a pipeline that has strong potential to address high unmet medical needs,” concluded Mr. Lvesque.
https://www.theratech.com/news-releases/news-release-details/theratechnologies-announces-preliminary-fourth-quarter-and-full/