ObvioHealth, IQVIA Consumer Health, and Jovie USA Launch Innovative At-Home Trial to Bring First Goat Milk-Based Infant Formula to the United States

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Mar 07, 2023, 09:00 ET

The fully decentralized clinical trial was designed with guidance from the FDA, which is anticipated to fast-track approval for Jovie USA's goat milk-based formula.

NEW YORK, March 7, 2023 /PRNewswire/ -- ObvioHealth, in partnership with IQVIA Consumer Health, announces the launch of a fully decentralized clinical trial with Jovie USA to bring the first FDA-approved goat milk-based infant formula to the United States. The innovative study design is the first of its kind for infant formula, allowing parents and their newborns to participate in the trial from their homes without the need for in-clinic visits. ObvioHealth and Jovie involved the FDA in the design of the study to increase the probability of regulatory success upon the completion of the trial.

The study is designed to evaluate whether babies fed Jovie's goat milk-based formula show similar growth to babies who are fed cow milk-based formula or breast milk, the CDC's growth standard. Participants receive a scale and measuring devices, which are sent to their homes, and are trained during video calls by pediatric nurses on how to take the vital measurements essential to tracking healthy newborn growth. Nurses provide close oversight during measurements to ensure all is done correctly. The caregivers then use ObvioHealth's app to report weekly measurements throughout the duration of the study.

ObvioHealth's COACH (Clinical Oversight and Coordination Hub) team provides end-to-end, personalized assistance to caregivers via in-app messaging, phone, or video calls and remotely monitors trial data to ensure patient safety. ObvioHealth's DCT platform is programmed to alert the COACH team of potential adverse events, such as an infant's growth falling below the CDC threshold.

"Our partnership with Jovie illustrates how decentralized studies can reach hard-to-recruit newborn populations and their parents," said Ivan Jarry, CEO of ObvioHealth. "We're very excited to be a part of this effort to make it easier for parents to participate in such a trial, with training and support from expert clinicians and without having to make burdensome visits to clinics."

In the U.S., four companies control approximately 90 percent of the infant formula market, an issue highlighted in 2022 at the peak of the U.S.'s formula shortage. Few other options are available to U.S. parents. Globally, goat milk infant formula is widely accepted, appreciated for its easier digestibility and nutrient absorption, and proven in clinical trials to be as safe and effective as cow milk formula and breastmilk.

"Parents in the U.S. who can't or don't want to breastfeed deserve more options," said Jan van Marwijk Kooij, CEO of Jovie USA. "We are excited to have the opportunity to bring the first goat milk-based infant formula to the U.S. market, and we believe this trial will prove to regulators and parents alike that goat milk-based infant formula is an excellent choice."

For more information about ObvioHealth, visit www.obviohealth.com.

For more information about Jovie USA's goat milk-based formula, visit www.jovieusa.com

SOURCE ObvioHealth