Bubs Australia says 400 infants have been enrolled in its growth monitoring study (GMS) and clinical trial, currently underway in the US. The research is part of the US Food and Drug Administration’s (FDA) regulatory requirements for permanent access to its infant formula market.
Bubs plans to formally submit the completed GMS and clinical trial documentation in early 2025, with FDA approval expected in October 2025, which will see it shift from ‘temporary enforcement discretion’ to permanent market access.
Its temporary licence was granted in May 2022 as part of ‘Operation Fly Formula’, a campaign by the US government to address its infant formula shortage. Bubs was the first company outside of the country to help.
The company said full enrolment in its trial was a “significant milestone”, with the first enrolment only taken in August last year.
Bubs chief operating officer, Richard Paine, said the company continues to build trust with parents, caregivers, and healthcare professionals.
“With our 400th infant now enrolled in the study, Bubs can finalise and submit the necessary data to the FDA in what is a critical step towards achieving permanent market access. We are pleased to have finalised patient enrolment in a significant study involving three distinct Bubs Infant Formulas,” Paine said.
The trial involves a nationwide Growth, Tolerance, and Safety study of healthy term infants consuming Bubs’ infant formulas, monitored by healthcare professionals. The study evaluates all three stage 1 formulas in the market including goat milk, two cow milk products and a commercially available formula as the control. It also has a breast-feeding cohort for reference. Infant growth during the study is measured by healthcare professionals at designated clinical sites, with additional input from parents and caregivers.
Bubs’ trial is being overseen by principal investigator, Dr Keith Aqua, who has run more than 350 clinical trials.
Bubs has already completed other parts of the regulatory process including the ‘protein efficiency ratio study’, and its ‘generally accepted as safe’ application.
