Key Highlights

• The FDA granted Vectus Biosystems a pre-IND Type B meeting request for VB0004 in Idiopathic Pulmonary Fibrosis.

• Written FDA responses are expected to be received by mid-November 2026.

• VB0004 is a first-in-class oral antifibrotic compound with a completed Phase Ia safety and pharmacokinetic study.

• The pre-IND meeting will inform the regulatory strategy for VB0004's clinical development in the US.

Vectus Biosystems Limited (ASX:VBS), an Australian clinical-stage biotechnology company, announced on 30 September 2026 that the US Food and Drug Administration has granted the company's request for a pre-Investigational New Drug Type B meeting for its lead compound VB0004 in the treatment of Idiopathic Pulmonary Fibrosis (IPF). The FDA's written responses to Vectus' proposed development program are expected by mid-November 2026.

About Vectus Biosystems

Vectus Biosystems is an Australian clinical-stage biotechnology company developing novel therapies for fibrotic diseases. Its lead candidate, VB0004, targets IPF — a progressive and often fatal lung disease with significant unmet medical need. VB0004 is described as a first-in-class oral vasoactive intestinal peptide mimetic and natriuretic peptide receptor C agonist that has demonstrated the ability to reverse established fibrosis in pre-clinical models.

Beyond IPF, Vectus is advancing antifibrotic Assets targeting cardiovascular, renal, and liver fibrosis. One of its renal fibrosis assets has been licensed to an international biotechnology company, providing a validation of its platform's commercial potential.

Pre-IND Meeting: Regulatory Significance

A pre-IND Type B meeting is a formal process by which a pharmaceutical developer obtains written guidance from the FDA on a proposed clinical development program before filing an Investigational New Drug application. This type of engagement provides companies with direct regulatory input on issues such as trial design, safety requirements, and chemistry, manufacturing, and controls specifications — reducing the risk of deficiencies in a subsequent IND submission.

For Vectus, the granting of this meeting request represents confirmation that the FDA will engage formally with the company's proposed development plan for VB0004 in IPF. Working in conjunction with Cardinal Health Regulatory Services as its US Regulatory Agent, Vectus will now finalise and submit its meeting package to the FDA.

VB0004 Clinical Stage and IPF Context

VB0004 has completed a Phase Ia clinical study in healthy volunteers, establishing a favourable safety and pharmacokinetic profile. This phase assessed the compound's tolerability and how the body processes the drug, providing a foundation for the next stage of clinical testing.

IPF is a progressive lung disease characterised by scarring of lung tissue and carries a median survival of two to five years from diagnosis. The disease has limited approved treatment options, and no currently approved therapy has been shown to reverse established fibrosis. VB0004's pre-clinical data showing fibrosis reversal, if reproducible in human trials, could differentiate it from existing approved agents.

Next Steps

The company will now finalise its meeting package for submission to the FDA, with written regulatory responses expected by mid-November 2026. Those responses will inform the next stages of VB0004's clinical and regulatory development pathway in the United States. Until those responses are received, the precise scope and structure of planned clinical work in IPF remains subject to revision based on FDA guidance.

Key Takeaways

The granting of an FDA pre-IND Type B meeting for VB0004 is a procedural step that advances Vectus Biosystems' US regulatory groundwork for its lead IPF candidate. With Phase Ia safety data in hand and FDA engagement now secured, the company awaits formal written guidance expected by mid-November 2026 that will shape the trajectory of VB0004's further clinical development in one of the most underserved areas of respiratory disease.