22 July 2022 - - 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, US-based clinical-stage biopharmaceutical company Siolta Therapeutics said.

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 and Serious Adverse Events, 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.

STMC-103H is a Live Biotherapeutic Product 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.

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 m 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.

Siolta Therapeutics is a clinical-stage biopharmaceutical company developing targeted microbiome-based therapeutics to prevent and treat diseases of high unmet medical need.