Siolta Therapeutics Announces First Newborn Dosed in Their Phase 2 ADORED Study Evaluating a Potential First-In-Class Live Biotherapeutic Product for the Prevention of Atopic Diseases

 Siolta initiates dosing in newborn subjects in a groundbreaking trial of STMC-103H

Atopic diseases are the most common chronic diseases in infancy and childhood

SAN CARLOS, Calif.–(BUSINESS WIRE)–#atopicdiseases–Siolta Therapeutics, a clinical-stage biopharmaceutical company developing novel targeted live biotherapeutic products (LBPs) to prevent and treat diseases of high unmet medical need, today announced that the first newborn subject has been dosed in the adored study, a Phase 1b/2 trial of STMC-103H, a potential first-in-class microbiome-based therapeutic for the prevention of atopic diseases.

“We are excited to dose our first newborn in the Phase 2 portion of our adored study (www.adoredstudy.com) with STMC-103H, a novel LBP consortium. This safety, tolerability, and efficacy study to prevent the onset of atopic diseases in newborns will allow us to further evaluate the crucial role that the microbiome plays in human health,” said Nikole Kimes, Ph.D., President and Chief Executive Officer of Siolta. “I am grateful to the entire Siolta team, our investigators, and most importantly the families participating in this prevention study as we work together to find novel approaches to address the growing burden of atopic diseases.”

“There are no approved treatments available to prevent the onset of atopic diseases,” said Richard Shames, MD, Chief Medical Officer of Siolta. “The development of STMC-103H allows us to study an innovative and potentially transformative new intervention for newborns at-risk for allergic diseases based on an immediate family history. I am thrilled to lead the investigation of STMC-103H in this Phase 1b/2 trial.”

About the adored study

This is a Phase 1b/2, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety/tolerability and preliminary clinical efficacy of STMC-103H in neonates and infants at-risk for developing allergic disease (Type 1 hypersensitivity). Subjects are enrolled in a three-part sequential approach (Part A1, A2, and Part B). In the now-completed Parts A1 and A2 safety portions of the study, participants aged 1–6 years (Part A1) and 28 days–12 months (Part A2) received 28 days of treatment with STMC-103H or placebo, followed by 28 days of follow-up off study drug. The Data Safety Monitoring Committee reviewed safety data from Parts A1 and A2 and recommended the continuation of the study. Part B of the study will enroll 224 newborn subjects for approximately 1 year (336 days) of treatment with STMC-103H or placebo (1:1 randomization), followed by approximately 1 year (336 days) of follow-up. Primary safety endpoints include the development of Adverse Events (AEs) and Serious Adverse Events (SAEs), as well as findings on physical exams, vital signs, and clinical safety laboratories. The primary efficacy endpoint is the incidence of physician-diagnosed atopic dermatitis at day 336 in STMC-103H-treated subjects compared to placebo. For additional information about this clinical trial, please visit www.clinicaltrials.gov (NCT05003804) or the adored study website (www.adoredstudy.com).

About STMC-103H

STMC-103H is a Live Biotherapeutic Product (LBP) being developed by Siolta Therapeutics for the prevention and treatment of atopic diseases (atopic dermatitis, atopic asthma, food allergy, allergic rhinitis) in at-risk newborns based on an immediate family history of atopic diseases. STMC-103H contains a combination of bacterial species that are depleted in the gut microbiota of infants who go on to develop allergic sensitization and allergic diseases in childhood. In animal studies, STMC-103H’s immunomodulatory bacterial consortium functions synergistically to prevent allergic inflammation. In a completed phase 1 first-in-human study (STMC-103H-101), STMC-103H was well-tolerated in adults, adolescents, and children (age 4-11 years). STMC-103H received Fast Track Designation from the US FDA in 2020.

About Atopic Diseases

The atopic march refers to the tendency of atopic diseases to develop over infancy and childhood, beginning with atopic dermatitis and IgE-mediated food allergy to asthma and allergic rhinitis. An estimated 20 million children and adolescents live with atopic diseases in the US. Up to 30% of newborns are at-risk of developing atopic diseases. There are no approved products to prevent the development of these diseases in at-risk individuals, resulting in chronic morbidity, impaired quality-of-life, and a substantial economic burden.

About Siolta Therapeutics

Siolta Therapeutics is a clinical-stage biopharmaceutical company developing targeted microbiome-based therapeutics to prevent and treat diseases of high unmet medical need. Its lead program, STMC-103H is currently in phase 2 development to prevent atopic diseases in at-risk newborns. Siolta has successfully scaled up a multi-strain LBP drug product STMC-103H (>100K doses), completed a First-In-Human descending-age clinical trial (STMC-103H-101), and was recently awarded a $2.7M NIH grant to further advance its proprietary mixed-strain LBP manufacturing methods. By leveraging its Precision Symbiotics Platform™ the company is expanding its product pipeline into additional pediatric and women’s health indications. For more information, please visit www.sioltatherapeutics.com.

Contacts

Nikole Kimes, CEO

Siolta Therapeutics

415-991-0947