#USA #San Carlos #Siolta Therapeutics #STMC-103H #ADORED Study

Siolta Therapeutics Reports Positive Phase 2 Results from the ADORED Study

Siolta Therapeutics, a pioneering biotechnology company focused on developing innovative live biotherapeutic products (LBPs), has revealed encouraging findings from their Phase 2 ADORED study. This study investigates STMC-103H, an oral microbial therapy designed to prevent the onset of atopic diseases in infants with a family history of such conditions.

Study Overview

The ADORED (Allergic Disease Onset pREvention stuDy) study enrolled 238 at-risk newborns across 30 sites in the U.S. and Australia. A one-year treatment period was followed by a year-long observation to assess long-term outcomes. The primary aim was to evaluate the efficacy of STMC-103H in decreasing the incidence of atopic diseases, which include atopic dermatitis, food allergies, asthma, and allergic rhinitis.

The results have shown that infants who completed a full year of STMC-103H treatment experienced a 64% reduction in the risk of developing physician-diagnosed atopic dermatitis compared to those receiving a placebo. Notably, the statistical analysis spotlighted a significant difference, with atopic dermatitis manifesting in 23.3% of the treatment group versus 43.1% in the placebo group, corroborated by a notable p-value of 0.005.

Moreover, the therapy evidenced a 77% reduction in developing food allergies and showcased other favorable effects, such as a prolonged time to the onset of atopic dermatitis and decreased total serum IgE levels, essential markers in allergic responses.

Safety and Tolerability

Not only did STMC-103H exhibit considerable efficacy, but it also proved safe and well-tolerated. There were no significant differences in the occurrence of serious adverse events between the treatment and placebo groups, reinforcing the safety profile of this novel therapy.

Principal investigator Dr. Michael O'Sullivan commented on the potential impact of these findings, emphasizing the need for innovative approaches to address the rising global concern related to type 1 allergic diseases. The success of microbiome-targeted therapeutics like STMC-103H offers hope for preventing these conditions in vulnerable populations.

The Immune System and Microbiome

Atopic diseases pose a significant health challenge, affecting over 20% of infants and children in the U.S., particularly those with a family predisposition. The development of these diseases can lead to long-term health issues, diminished quality of life, and increased healthcare costs. The uniqueness of STMC-103H lies in its approach to bolster the infant microbiome—a vital player in immune development during early life—through a carefully curated group of beneficial bacterial strains familiar to healthy infants.

Richard Shames, MD, Siolta’s Chief Medical Officer, expressed excitement about the outcome of this therapy, indicating plans for further discussions with the FDA regarding the advancement of STMC-103H's development toward potential future approval.

Future Developments

The complete outcomes of the year-two follow-ups will be disclosed in the first quarter of 2026, but preliminary data strongly support the continued exploration and application of STMC-103H. Siolta Therapeutics aims to present detailed findings at upcoming medical conferences and within peer-reviewed journals, marking a significant step in addressing atopic diseases in infants.

In summary, the successful results of Siolta’s ADORED study underline a transformative perspective on preventive strategies for allergic diseases, prioritizing early intervention through microbiome health promotion. By reshaping immune development early in life, Siolta Therapeutics envisions a future with diminished prevalence of allergic conditions in children.