FORMaT Trial’s First Interim Analysis
The FORMaT Trial has reached its target recruitment for the first interim analysis (61 participants recruited to the Intervention Program). The first interim analysis for FORMaT is on track to be performed in early May 2026. This interim analysis will analyse the primary outcome for the first 61 participants completing the first 6 weeks of FORMaT Intensive Phase treatment.
After the completion of this interim analysis two of the current Intensive Treatment arms with the best microbiological clearance with tolerance will continue, and the other arm will be dropped. This decision will be made after review of the interim analysis outcome reports by the independent FORMaT Trial oversight committees (including the Data and Safety Monitoring Board, the Trial Steering Committee and the Consumer Advisory Group).
A novel Intensive Treatment Arm D (combination of intravenous (IV) Sulbactam-Durlobactam (SUL-DUR) with IV ceftriaxone, oral amoxicillin, azithromycin and clofazimine) will be introduced to the FORMaT platform. The Sulbactam-Durlobactam is being provided in-kind by our industry partner – Innoviva Specialty Therapeutics (IST).
This new Intensive treatment arm is planned to be rolled out in early 2027 in line with our industry partner’s timelines for provision of the in-kind Sulbactam-Durlobactam supply.
The FORMaT protocol will be amended once the interim analysis results are known and the trial oversight committees have made their assessment and decision on which current Intensive treatment arm will be dropped. This protocol amendment will be submitted to the relevant regulatory and ethical bodies for review and approval before the roll out of the novel Arm D.