- Bubs Australia (BUB) initiates a nationwide infant formula clinical trial in the United States
- It reinforces the company’s commitment to the North American market
- The trial focuses on evaluating infant formulas and aims to secure a permanent market position for Bubs in Northern America
- The company plans to submit the study results to the FDA by September 2024, with a full infant formula submission scheduled for October 2024
- Bubs was last trading at 17 cents
Bubs Australia (BUB) has initiated its Growth Monitoring Study (GMS) clinical trial in the United States, reaffirming its commitment to the North American market.
The company’s entry into the US dates back to May 2022 when it responded to an infant formula shortage crisis. As part of the US Government’s Operation Fly Formula program, Bubs promptly delivered its formulas to retail shelves.
This latest study, commencing nationwide enrollment, is designed to assess the growth, tolerance, and safety of new infant formulas as a standard part of the US regulatory process.
The first infant was enrolled in late August, and Bubs aims to enrol more through 13 healthcare clinics across the country.
Following its successful completion of the Protein Efficiency Ratio (PER) study in June 2023, which validated protein quality, Bubs has been preparing for this clinical trial.
The company plans to submit the GMS results to the FDA by September 2024, with a full infant formula submission scheduled for October 2024.
These steps are crucial in transitioning from a state of “temporary enforcement discretion” to a permanent market presence for Bubs in the USA and Northern America.
“We are excited to build upon that relationship by providing the FDA with the data necessary for Bubs to take up its permanent place in the American market,” Bubs COO Richard Paine said.
The evaluation includes all three stage-one formulas in the market: goat milk, two cow milk products, and a commercially available formula as a control. Additionally, a breastfeeding cohort is included for reference.
Infant growth will be meticulously tracked by healthcare professionals at designated clinical sites, with valuable input from parents and caregivers.
Principal investigator Dr Keith Aqua, a figure in obstetrics and gynecology, is leading the study.
Bubs Australia was last trading at 17 cents.