Shares of Theratechnologies (NASDAQ: THTX) are on the rise following the company's announcement that the United States Food and Drug Administration has granted fast track designation to TH1902 to as a single agent for treating patients with sortilin positive recurrent advanced solid tumours that are refractory to standard therapy.
Theratechnologies stock price is currently trading at $2.96 up 26.5% at the time of writing.
“Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology™ and further supports the future development of TH1902,” said Dr Christian Marsolais, Senior Vice President and Chief Medical Officer at Theratechnologies.
FDA fast track designation is designed to facilitate the development and expedite the review of drugs to treat severe conditions and fill an unmet medical need.
On the 7th of January 2021, the Montreal-based firm announced it received a “Study May Proceed” letter from the FDA for its Phase 1 clinical trial of TH1902.
The trial design includes a dose-escalation study to evaluate safety pharmacokinetics, maximum tolerated dose, and plural preliminary antitumor activity of TH1902 administered once every three weeks in patients with advanced solid tumours refractory to available anticancer therapies.
Once the maximum tolerated dose is determined, Theratechnologies plan to enrol an additional 40 patients to evaluate the potential antitumor activity of TH1902 in patients with endometrial, ovarian, colorectal, pancreatic, and triple-negative breast cancers.
The Phase 1 trial is expected to begin in the second quarter of 2021.