Theratechnologies Inc. announced that it has decided to pause the enrollment of patients in its Phase 1 clinical trial of TH1902, the Company's lead investigational peptide drug conjugate (PDC) for the treatment of sortilin-expressing cancers. The Company plans to submit an amendment to its protocol to the U.S. Food and Drug Administration (FDA) for approval. Theratechnologies voluntarily made the decision to pause enrollment and revisit the study design after consulting with its investigators.
Efficacy results observed thus far were not convincing enough to pursue enrolling patients and did not outweigh the adverse events seen in some patients. As previously reported, these adverse events consist mainly of neuropathy and eye toxicity. The current intent for the protocol amendment is to modify the dosage regimen to optimize the delivery of TH1902, with lower doses at more frequent intervals.
The Company continues to investigate the results obtained thus far in the Phase 1 clinical trial.