FORMaT News and Updates

May 2026: 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 one of the current Intensive Treatment arms will be dropped – either due to poor treatment tolerance and/or efficacy. 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.

November 2025: Scientific Leadership & International Recognition

In 2025, the FORMaT team presented at multiple major international conferences, including:

• The American Thoracic Society (ATS) Conference 2025
• The 48th European Cystic Fibrosis Society Conference
• The 8th World Bronchiectasis Conference
• The European Respiratory Society Congress 2025
• The North American Cystic Fibrosis Conference 2025
• The Australian Non-tuberculous Mycobcaterium Symposium 2025

These presentations showcased new insights into Mycobacterium abscessus lung disease treatment toxicity, immune biomarkers, and novel medical imaging markers—highlighting FORMaT’s growing reputation as the leading global platform for Mycobacterium abscessus lung disease research.

Below: FORMaT Senior Research Pharmacists Mr Daniel Hicks and Mrs Megan Rice presenting “Adverse Events leading to treatment withdrawal and interruption in Mycobacteroides abscessus complex pulmonary disease” abstract at the 8th World Bronchiectasis Conference in Brisbane, Australia.

Below: “Adverse Events leading to treatment withdrawal and interruption in Mycobacteroides abscessus complex pulmonary disease” abstract presentation at 8th World Bronchiectasis Conference in Brisbane, Australia.

Below: Ms Kara Brady presenting “An Overview of the FORMaT Trial” at the NTM Symposium Australia 2025 in Brisbane, Australia.

Professor Rachel Thomson presenting “A comparison of FORMaT Observation versus Intervention participants at Baseline” at the NTM Symposium Australia 2025 in Brisbane, Australia.

Mr Daniel Hicks presenting “Safety, Tolerance and Pharmacovigilance in the FORMaT Trial” at the NTM Symposium Australia 2025 in Brisbane, Australia.

FORMaT team panel discussion at the NTM Symposium Australia 2025 in Brisbane, Australia.