STMC-103H / Siolta Therap - LARVOL DELTA

STMC-103H Reduces Risk of Atopic Dermatitis and Food Allergy in At-Risk Infants: Results of the Phase 1b/ 2 Randomized, Double-Blind, Placebo-Controlled ADORED Trial (AAAAI 2026) - "These results suggest that STMC-103H may help protect against atopic disease development in at-risk infants who complete treatment as planned, supporting further investigation in larger, confirmatory trials."

Clinical • Late-breaking abstract • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology

STMC-103H Reduces Risk of Atopic Dermatitis and Food Allergy in At-Risk Infants: Results of the Phase 1b/ 2 Randomized, Double-Blind, Placebo-Controlled ADORED Trial (AAAAI 2026) - "STMC-103H was well-tolerated with no differences in serious adverse events or adverse events of special interest. Conclusions These results suggest that STMC-103H may help protect against atopic disease development in at-risk infants who complete treatment as planned, supporting further investigation in larger, confirmatory trials."

Clinical • Late-breaking abstract • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology

Investigational Therapy STMC-103H May Protect At-Risk Infants Against Development of Atopic Disease (Pharmacy Times) - "The findings indicated that infants who completed the full duration of STMC-103H treatment demonstrated an approximate 64% reduction in the risk of developing AD compared with placebo (23.3% vs 43.1%; OR = 0.36 [90% CI 0.20-0.66]; unadjusted p = .005) at the end of treatment. Additionally, STMC-103H reduced the risk of development of physician-diagnosed food allergy by 77% (4.7 vs 16.7%; OR = 0.23 [90% CI 0.09-0.63]; unadjusted p = .02) and time to AD diagnosis (unadjusted p = .01) in subjects who completed treatment as planned and total serum immunoglobulin E (unadjusted p = .03)."

P1/2 data • Atopic Dermatitis • Food Hypersensitivity

Siolta Therapeutics Announces Upcoming Late Breaking Oral Presentation of Results from the Phase 2 ADORED trial at 2026 AAAAI meeting (PRNewswire) - "...Abstract describing the one year results from the company's Phase 2 ADORED clinical trial of STMC-103H in infant subjects at-risk for development of atopic diseases (atopic dermatitis, food allergy, allergic asthma, allergic rhinitis/ conjunctivitis) has been accepted..."

Late-breaking abstract • P2 data • Allergic Rhinitis • Asthma • Atopic Dermatitis • Food Hypersensitivity

adored: Allergic Disease Onset Prevention Study (clinicaltrials.gov) - P1/2 | N=283 | Completed | Sponsor: Siolta Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Siolta Therapeutics Reports Positive Phase 2 Results from the ADORED Study (PRNewswire) - "Subjects who completed the full year of treatment with STMC-103H demonstrated a 64% reduction in the risk of developing physician-diagnosed atopic dermatitis compared to placebo at one year after initiation of treatment (23.3% vs. 43.1%; OR = 0.36; 90% CI 0.20-0.66; n=158; p = 0.005). When all randomized infants, including those who received less than 1 year of treatment, were included in the end-of-treatment analysis, the results did not reach statistical significance; STMC-103H showed consistent and clinically meaningful improvements across additional secondary endpoints at one year, including a 77% reduction in the risk of developing physician-diagnosed food allergy (4.7 vs. 16.7%; OR = 0.23; 90% CI 0.09-0.63, p=0.02), prolonged time to development of atopic dermatitis (p=0.01) and reduced total serum IgE (p=0.03) compared to placebo, in those subjects who completed treatment as planned....End of study (Year 2) clinical outcome data will be finalized and reported in Q1 of 2026."

P2 data • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis

adored: Allergic Disease Onset Prevention Study (clinicaltrials.gov) - P1/2 | N=264 | Active, not recruiting | Sponsor: Siolta Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P1b/2 ➔ P1/2

Enrollment closed • Phase classification • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

adored: Allergic Disease Onset Prevention Study (clinicaltrials.gov) - P1b/2 | N=264 | Recruiting | Sponsor: Siolta Therapeutics, Inc. | Trial completion date: Dec 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

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 (Businesswire) - "Siolta Therapeutics...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....'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.'"

Trial status • Atopic Dermatitis • Immunology

adored: Allergic Disease Onset Prevention Study (clinicaltrials.gov) - P1b/2; N=264; Recruiting; Sponsor: Siolta Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Allergy • Atopic Dermatitis • Dermatitis • Dermatology • Immunology