Transcode Therapeutics’ TTX-MC138 achieves safety endpoint in Phase 1a study

TransCode Therapeutics (RNAZ) completed its Phase 1a clinical trial with TTX-MC138, an investigational inhibitor of microRNA-10b, or miR-10b. By meeting its primary safety endpoint and defining a recommended Phase 2 dose, TTX-MC138 is moving forward into the next stage of clinical evaluation to assess its efficacy across selected metastatic diseases and for multiple indications. No significant treatment-related safety events or dose limiting toxicities were observed. Primary objectives of the trial focused on safety, tolerability, pharmacokinetics and establishment of a Phase 2 dose. TTX-MC138 was administered to 16 patients with positive pharmacodynamic effects over all four administered dose range levels. Importantly, the duration of treatment for all patients ranged from two to 12 cycles, indicative of tolerability and disease control. 44% or 7/16 patients were classified as having stable disease lasting 4 months or longer. Preliminary data in 16 patients showed positive pharmacodynamic effects over a wide dose range. Data analysis and monitoring are ongoing. A final clinical study report, scientific presentations and publications are planned.