SAN DIEGO, Jan. 23, 2025 (GLOBE NEWSWIRE) -- Persephone Biosciences Inc., a commercial company restoring and reinvigorating the human gut microbiome through clinically validated synergistic synbiotics, today announced that the first subject has been enrolled in the ARTEMIS (NCT06746285) clinical study of its new, proprietary, infant synergistic synbiotic (a precision matched prebiotic and probiotic). Persephone’s infant synbiotic was created based on findings from the company’s My Baby Biome clinical study, launched in August 2022.
“Following years of research into the human microbiome, we are delighted both to be closing in on the launch of our groundbreaking infant synbiotic, as well as starting the ARTEMIS clinical trial that will study its effect on the microbiome of both babies and toddlers,” said Stephanie Culler PhD, CEO and Co-founder of Persephone Biosciences. “Our probiotic contains four validated strains that have never before been given in combination, in conjunction with human milk oligosaccharides (HMOs) and Vitamin D. We believe this synergistic combination of probiotics and prebiotics - serving as specific nutrients for these microbes - has the potential to improve infant health.”
Culler continued: “We will be studying the effects of our synbiotic in babies that are breast-fed as well as those fed with baby formula. Looking ahead, we hope this trial will be the first of many that will study our breakthrough synbiotic in various environments, potentially including infants born by cesarean section, as well as those who have received courses of antibiotics. Ultimately, we seek scientific evidence to share with parents and physicians for what we believe could be a category-redefining synbiotic for newborn babies and toddlers.”
The ARTEMIS study will enroll up to 200 subjects, divided into 2–12-month-old babies and 12–24-month-old toddlers, and will include control arms. Subjects receiving treatment will be given a 30-day supply of Persephone Biosciences’s proprietary infant synbiotic. Persephone Biosciences plans to collect stool samples from subjects before, during, and after synbiotic treatment, to determine levels of microbiome colonization, changes to the subject’s immune profile, as well as to generate evidence of the synbiotic’s safety and tolerability. Charles Baum, M.D., will be the study’s principal investigator. Dr. Baum is a gastroenterologist with extensive experience in microbiome-focused clinical studies through his involvement in Persephone Biosciences’s ongoing ARGONAUT study targeting improved oncology treatment response and prevention.
“To my knowledge, this clinical trial will be the largest ever to study the effects of a synbiotic on the infant gut microbiome,” said Dr. Baum. “With so many infant supplements of questionable design and efficacy on the market, the ARTEMIS study should differentiate and elevate Persephone Biosciences’s synbiotic by providing parents with the scientific evidence needed to make informed decisions about their children’s health.”
“Clinical studies for probiotics are rare. The clinical trial that Persephone Biosciences is launching demonstrates the company’s commitment to improve the health of both infants and toddlers,” said Richard Insel, M.D., Persephone’s Chief Medical Advisor and Research Professor, University of Rochester School of Medicine & Dentistry and former Head of Pediatric Health and Wellness at Kenvue (formerly Johnson & Johnson Consumer Health), who is a co-investigator on the study. “There is growing evidence to suggest that the infant gut microbiome in the modernized world has changed and may be contributing to poor child health. The insights generated from this trial could prove invaluable in helping reverse this negative health trend.”
Persephone Biosciences expects to share insights from the trial through an initial data readout in 1H 2025, coinciding with the commercial launch of its infant synbiotic, and to publish findings from the completed study in 2026.
Interested parents can enroll their children in the study here:
https://go.persephonebiosciences.com/artemis/
About Persephone Biosciences
Persephone Biosciences is a biotechnology company reimagining patient health through the development of microbiome-based products. Persephone Consumer Health is focused on adult and infant wellbeing, through the development of pioneered probiotics (My Baby Biome™ clinical study) and its Food as Medicine (AMBROSIA clinical study). Persephone Therapeutics is targeting improved patient therapeutic response, with an initial focus on oncology treatment and prevention (ARGONAUT clinical study). The company was founded in 2017 by synthetic and metabolic engineers, Stephanie Culler, Ph.D., and Steve Van Dien, Ph.D. For more information, visit www.persephonebiosciences.com or LinkedIn.
Investor contact:
Laurence Watts
New Street Investor Relations
