Siolta Therapeutics Reports Positive Phase 2 Results from the ADORED Study

STMC-103H exhibited 64% reduction in the risk of atopic dermatitis in subjects who completed one year of treatment with strong and consistent effects across multiple efficacy endpoints and was safe and well-tolerated

Excerpt from the Press Release:

SAN CARLOS, Calif., Nov. 17, 2025 /PRNewswire/ — Siolta Therapeutics, a clinical-stage biotech company developing first-in-class live biotherapeutic products (LBPs), today announced positive top-line results from the Phase 2 ADORED study (Allergic Disease Onset pREvention stuDy) of STMC-103H, its lead investigational oral microbial therapy. STMC-103H is being developed for the prevention of atopic diseases (atopic dermatitis, food allergy, asthma, allergic rhinitis/ conjunctivitis) in infants with an immediate family history of atopic disease. The trial assessed safety and efficacy as measured by the ability of STMC-103H to reduce the incidence of atopic disease in at-risk infants compared with placebo over the two-year study period. Infants who completed the full year of treatment demonstrated a clinically meaningful reduction in the risk of developing atopic dermatitis and food allergy at the end of the one-year treatment period in the per protocol analysis, accompanied by consistent improvements across additional secondary measures. STMC-103H was safe and well tolerated in the study. These results suggest that STMC-103H may protect against atopic disease development in at-risk infants who complete the treatment as planned, supporting further development of this novel microbiome-targeted therapy.

“Type 1 allergic diseases such as atopic dermatitis, food allergy and asthma represent a growing global health concern” said Dr Michael O’Sullivan, Consultant Clinical Immunologist and Allergist at Fiona Stanley Hospital and principal investigator of the ADORED study. “These data provide compelling evidence that microbiome-based therapeutics like STMC-103H, may offer a novel and effective strategy for prevention of these allergic diseases.”

Key Findings:

• The Phase 2 randomized, double-blind, placebo-controlled proof-of-concept trial enrolled 238 newborns across 30 sites in the United States and Australia. Following the one-year treatment, subjects were followed for an additional one year without treatment. P-values reported below were unadjusted for multiplicity.

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