RE: Musella news letter2 Dec 2025 17:51
Based on the RNS releases regarding the Phase 1 trial of Oral Gallium Maltolate (GaM), here is the timeline for when the patient recruitment milestones were reported:
📅 Timeline of Phase 1 Patient Enrollment Milestones
1. Nearing Completion (The Final Few Patients)
Date of RNS: Friday, April 11, 2025
Status Reported: The company announced the study was "nearing completion, with three subjects left to be enrolled in the expansion phase". This provided a clear indication that the enrollment process was winding down.
2. The "Soft Close" (No New Patients)
Date of RNS: Monday, July 21, 2025
Status Reported: Imaging Biometrics announced a "soft close" to the Phase 1 trial.
Implication: This meant that while the trial remained active for currently enrolled participants, no additional patients were being recruited. This decision reflected that the trial had achieved "sufficient enrollment to meet the trial's statistical and operational objectives" and allowed the team to transition immediately to data consolidation and Phase 2 protocol finalization.
3. Formal Completion
Date of RNS: Monday, November 10, 2025
Status Reported: The company announced the successful completion of the Phase 1 clinical trial. The trial had enrolled 26 patients in total.
In summary, the last few patients were enrolled sometime between April 2025 (when three were left) and the "soft close" in July 2025 (when enrollment stopped). The company achieved its target enrollment of 26 patients.