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TransCode Therapeutics Announces First Patient Dosed in Third Cohort with Lead Candidate in Phase 1 Clinical Trial
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities
About this update from Transcode Therapeutics, Inc.
[{"type":"text","content":"Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2\nNo significant safety or dose limiting toxicities reported in Cohorts 1 and 2PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial resultsBOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that the first patient in Cohort 3 of its Phase 1 clinical trial has been dosed with TTX-MC138, its lead candidate. The Safety Review Committee monitoring the clinical trial unanimously approved opening of the third cohort based on its favorable review of Cohort 1 and 2 safety and pharmacokinetic (PK) data. Additional Cohort 3 patients have been scheduled. The dose administered to patients in the third cohort is approximately double the dose administered to those in the second cohort.\n\n \n \n \n \n \n \n\n \nSeveral patients in the first and second cohort remain on study for continued treatment, receiving additional doses of TTX-MC138. No significant safety or dose limiting toxicities have been reported. Analyses of PK data and pharmacodynamic (PD) activity from Cohorts 1 and 2 is ongoing. To date, the analyses suggest that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode's previous Phase 0 clinical trial. Specifically, results from Cohort 1 confirmed the Phase 0 observation that TTX-MC138 shows evidence of pharmacodynamic activity in the presence of high baseline expression of miR-10b, reaching a 66% inhibition at 24 hours after infusion, similar to that seen in the Phase 0 trial. Additionally, TTX-MC138 activity increased with the escalated dose administered in Cohort 2 and was consistent at subsequent administrations of TTX-MC138, suggesting a favorable pharmacokinetic profile.\n\"An SRC is a group of clinicians and other experts that oversee patient safety during a clinical trial. The SRC determines whether and how a study should proceed, including dose escalation and de-escalation decisions in accordance with the study design. Enrollment into this study continues based on the SRC's cumulative safety data review. We are very pleased with the commitment from our clinical sites which may enable quick completion of the third co...