Theratechnologies Inc. provided an update on its planned Phase 3 clinical trial evaluating tesamorelin for the treatment of nonalcoholic steatohepatitis (NASH). The Company also announced that discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding its proposed trial design and protocol for its Phase 3 clinical trial evaluating tesamorelin for the treatment of NASH are complete. In addition, the Company has initiated a search for a potential partner to help launch the program. Update on Phase 3 clinical trial evaluating tesamorelin in NASH: Discussions with the FDA and the EMA on the trial design are complete. The Phase 3 clinical trial will include participants in the U.S. and Europe. The Phase 3 clinical trial will be a multicenter, double-blind, placebo-controlled two-part study to evaluate the safety and efficacy of tesamorelin in liver-biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis. The Phase 3 clinical trial will include a futility analysis that will be performed after approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy. A supplemental Biologics Licence Application (sBLA) is expected to be filed after approximately 1,100 patients, including approximately 75 to 100 people living with HIV, have completed 18 months of treatment and have received a second liver biopsy. The primary endpoint will be NASH resolution and no worsening of fibrosis compared to placebo after 18 months as per FDA guidelines. Following potential approval, an additional 1,800 patients are expected to be enrolled, to continue measuring clinical outcomes over a period of five years. Based on regulatory discussions, the final Phase 3 clinical trial design will result in higher costs than what the Company had previously estimated. As a result of the total cost of the Phase 3 clinical trial, the Company is now evaluating its options to best execute its late-stage development program, including seeking a potential partner. An external U.S.-based biopharma advisory firm has been retained to assist in identifying a potential partner. Partner identification and negotiations will alter the initiation of the Phase 3 clinical trial that was previously expected to begin in the third quarter of calendar year 2021. Update on SORT1+ Technology in oncology: New preclinical findings for TH1902 in metastatic cancers: On June 21, 2021, the Company announced new preclinical in vivo findings on the anti-metastatic effect and tolerability of its novel investigational proprietary peptide-drug conjugate (PDC), TH1902. These results demonstrated that TH1902 had better anti-metastatic activity when compared to docetaxel alone when administered at an equimolar concentration in a lung metastasis cancer model expressing the sortilin (SORT1) receptor. In conjunction with the announcement, the Company hosted a webinar on its SORT1+ Technology™ featuring Richard Béliveau, Ph.D., Université du Québec à Montréal, who discussed the science of receptor-mediated cancer therapy and the discovery of sortilin as a novel target in cancer treatment. The archived webcast event can be accessed on the Theratechnologies website under ‘Past Events’. Phase 1 clinical trial of TH1902 for the treatment of sortilin-expressing cancers progressing: Following fast track designation from the FDA, the Phase 1 clinical trial evaluating TH1902 in sortilin-expressing solid tumors is progressing as planned. At this time, the Company expects to obtain interim safety and efficacy information from the Phase 1 Part A study in the fourth quarter of calendar year 2021.