Theratechnologies to amend, optimize protocol for Phase 1 trial of TH1902

Theratechnologies announced an update on the plan to amend and optimize the protocol of its Phase 1 oncology clinical trial with the goal of a timely re-submission to the United States Food and Drug Administration. Following a voluntary pause in the study’s enrollment on December 1, 2022, the Company formed a Scientific Advisory Committee to help determine the best developmental path forward for TH1902. In addition to the study’s principal investigator, the SAC includes several medical oncologists from across the U.S., who are leading experts in the end-to-end lifecycle of oncology drug development: Erika Hamilton, MD, director of Breast Cancer and Gynecologic Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology; Daniel Petrylak, MD, professor of medicine in Medical Oncology and Urology and chief, Genitourinary Oncology at Yale School of Medicine; and Anthony Tolcher, MD, medical oncologist at Texas Oncology-San Antonio Medical Center. The Company will continue to seek advice and input from Mace Rothenberg, MD, who is currently a scientific advisor to Theratechnologies. Theratechnologies is currently analyzing data and preparing responses to questions received from the FDA. This work is well underway and will be considered by the SAC as part of their meeting, which is scheduled for the latter half of March when the analyses are expected to be ready. Once expert advice is considered, the Company intends to promptly amend the protocol and re-submit to the FDA. Consistent with the Company’s 2023 objective of generating positive adjusted EBITDA by fiscal year end, any new investments in TH1902 will be stage gated. Once the Phase 1 clinical trial has resumed, Theratechnologies will also evaluate potential partnerships for TH1902.