Bubs Australia (ASX:BUB), a leading infant formula and baby food company, has announced the commencement of a nationwide clinical trial in the United States. This initiative marks a significant milestone in the company's dedication to serving North American families. Bubs' Growth Monitoring Study (GMS) clinical trial is designed to evaluate the growth, tolerance, and safety of new infant formulas, aligning with the standard U.S regulatory process.
The first infant was enrolled in the study in late August, and Bubs plans to actively enroll infants online and through thirteen highly regarded healthcare clinics across the United States. This comprehensive study is part of Bubs' ongoing commitment to providing high-quality infant nutrition to American families.
Bubs entered the U.S. infant formula market in May 2022 in response to an infant formula shortage, becoming the first company to offer assistance from abroad. The company proudly participated in the U.S. government's Operation Fly Formula program to expedite the availability of formula on retail shelves. Since then, Bubs has worked tirelessly to establish itself as the number one goat milk formula brand in the United States, gaining the trust of caregivers and pediatricians.
In line with U.S. Food and Drug Administration (FDA) guidelines, Bubs is actively transitioning from temporary 'enforcement discretion' to a permanent market position. Planning for the clinical trial began earlier this year, in close partnership with the FDA. The successful completion of the Protein Efficiency Ratio (PER) study in June 2023, a key U.S. regulatory milestone that validates protein quality, paved the way for the clinical trial.
Bubs aims to submit the results from the Growth Monitoring Study to the FDA by September 2024, with a full infant formula submission planned for October 2024. The ongoing partnership with the FDA and the formal regulatory approval processes remain top priorities for Bubs' management team.
Richard Paine, Chief Operating Officer of Bubs Australia, stated, "Bubs answered the call when we were needed by American families, and in so doing established a trusted relationship with many US healthcare professionals, parents, and caregivers. 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' clinical trial encompasses a nationwide Growth, Tolerance, and Safety study of healthy term infants consuming Bubs' infant formulas, closely monitored by healthcare professionals. The study evaluates all three Stage 1 formulas currently available in the market, including Goat Milk and two Cow Milk products, alongside a commercially available formula serving as the control. Additionally, the study includes a breast-feeding cohort for reference purposes. Infant growth during the study will be measured by healthcare professionals at designated clinical sites, with additional input from parents and caregivers.
The clinical trial is being conducted by Validcare, an innovative Contract Research Organization (CRO) specializing in electronic data capture to streamline patient enrollment, participation, and results analysis. Principal Investigator Dr. Keith Aqua, Co-Founder of the HCA Florida Institute for Women's Health and Body, and the Co-Founder of Visions Clinical Research, is overseeing the study. Dr. Aqua, a board-certified obstetrician and gynecologist, and a Certified Physician Investigator, brings extensive experience having served as the Principal Investigator on over 350 clinical trials.
"As this study's principal investigator and practicing clinician, I am pleased to lead this important study and potentially provide moms and babies with ongoing, expanded choices for quality infant formula – especially in light of recent shortages," said Dr. Keith Aqua, MD.
Bubs Australia continues to demonstrate its unwavering commitment to providing safe and nutritious infant nutrition, further solidifying its position as a trusted brand in the North American market. This clinical trial is a significant step towards ensuring the highest standards of infant formula quality and safety for American families.
