Key Highlights

  • The FDA granted Vectus's request for a pre-IND Type B meeting on its proposed development program for VB0004 in idiopathic pulmonary fibrosis.
  • Written FDA responses are expected by mid-November 2026, and the company is finalising its meeting package with its US regulatory agent.
  • No FDA feedback has yet been received, and VB0004 has completed only a Phase Ia study in healthy volunteers.

Vectus Biosystems Limited (ASX:VBS), an Australian clinical-stage biotechnology company developing therapies for fibrotic diseases, announced on 30 September 2026 that the US Food and Drug Administration has granted its request for a pre-Investigational New Drug (pre-IND) Type B meeting for VB0004 in idiopathic pulmonary fibrosis (IPF).

What has been granted

The FDA will table written responses on Vectus's proposed development program for VB0004 in IPF. The responses are expected by mid-November 2026. Granting the meeting request is a procedural step and not an assessment of the program, and the company has not yet submitted the meeting package.

Next steps

Together with its US regulatory agent, Cardinal Health Regulatory Services, Vectus will now finalise and submit its meeting package to the FDA. The company says the feedback will inform the next stages of VB0004's clinical and regulatory development and provide formal guidance on its proposed IPF program.

About VB0004

VB0004 is described as a first-in-class oral vasoactive intestinal peptide (VIP)-mimetic and natriuretic peptide receptor C (NPR-C) agonist in development for IPF. Vectus has completed a Phase Ia clinical study in healthy volunteers that it says established a favourable safety and pharmacokinetic profile, and US regulatory activities are now under way to establish a foundation for future clinical development in the US. The company says VB0004 has reversed established fibrosis in preclinical models, a finding that has not been tested in patients.

IPF and the wider pipeline

IPF is described as a progressive and often fatal lung disease with significant unmet medical need. Beyond IPF, Vectus is advancing a pipeline of antifibrotic Assets targeting cardiovascular, renal and liver fibrosis. It says the commercial potential of its platform has been externally validated by a licensing agreement with an international biotechnology company for one of its renal fibrosis assets, which it says shows a pathway for potential milestone and Royalty revenues, though the release gives no terms.

The meeting process

A pre-IND Type B meeting lets a sponsor seek FDA guidance on its development program before filing an Investigational New Drug application. In this case the FDA will table written responses, and Vectus is finalising the briefing package with Cardinal Health Regulatory Services. The release does not list the questions it will pose to the FDA or the trial design it intends to propose.

Company status

Vectus describes itself as an Australian clinical-stage company focused on fibrotic diseases, with an initial focus on IPF. It says VB0004 is a first-in-class antifibrotic candidate that has shown the ability to reverse established fibrosis in preclinical models and has completed Phase Ia clinical studies. The announcement notes it was authorised by the Board and is signed off by the company's chairman and chief executive.