In the course of the EIC project, significant progress has been made in advancing RTP-026 within clinical development, with a particular focus on the execution of a Phase 2a study in patients with ST-elevation myocardial infarction (STEMI) undergoing primary PCI.
The clinical trial protocol was successfully developed, approved by relevant regulatory authorities, and implemented across participating clinical sites. Site initiation activities were completed, and the Phase 2a study was initiated, enabling clinical evaluation of RTP-026 in the target patient population.
During the reporting period, recruitment and dosing were completed for the first cohort (Group A), and recruitment for the second cohort (Group B) was initiated following a favourable interim safety evaluation. In total, 54 out of the planned 64 patients were enrolled within the project period, corresponding to 84% of target enrolment. Interim safety data across both cohorts indicate an acceptable tolerability profile, with no major safety concerns identified.
Patient recruitment proved more challenging than initially anticipated. To address this, protocol adjustments were implemented, including refinement of inclusion criteria and expansion of screening capacity at clinical sites. These measures improved recruitment feasibility and supported continued study progress.
Overall, the project has achieved substantial progress toward its main objective of generating clinical safety and translational data for RTP-026 in STEMI patients. The results provide a solid foundation for completion of the Phase 2a study and progression to the next stage of clinical development.
