Drug intelligence / Profile preview

STMC-103H

Development stage: Phase 2
Lead developer: Siolta Therapeutics
Modality: Synthetic Biology Platforms → Engineered Microbial Therapeutics → Microbiome Therapeutics, Fresh FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Yeast Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Bacterial Strains → Single Strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Defined Consortia → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics, Frozen FMT → Fecal Microbiota Transplantation (FMT) → Microbiome Therapeutics, Genetically Modified Bacteria → Engineered Microbial Therapeutics → Microbiome Therapeutics, Microbial Metabolites → Microbiome-Derived Products → Microbiome Therapeutics, Microbial Proteins → Microbiome-Derived Products → Microbiome Therapeutics, Complex Communities → Multi-strain Products → Live Biotherapeutic Products → Microbiome Therapeutics
Administration: Oral

Overview

STMC-103H is an investigational oral live biotherapeutic product (LBP) developed by Siolta Therapeutics for the prevention of atopic diseases, such as atopic dermatitis, food allergy, and asthma, in at-risk newborns. [3, 6, 9, 11] It consists of a defined consortium of beneficial bacterial strains that are naturally found in healthy infants but are depleted in infants who later develop allergies. [3, 6, 11] By administering these bacteria, STMC-103H aims to modulate the infant's gut microbiome and support the healthy development of the immune system, thereby preventing immune dysregulation and the onset of the "atopic march". [3, 6] The product has received Fast Track designation from the US FDA and has shown positive top-line results in the Phase 2 ADORED clinical trial (NCT05003804), demonstrating a significant reduction in the incidence of atopic dermatitis and food allergy in infants treated for one year. [3, 7, 8, 9]

Beyond the preview

Go deeper on STMC-103H.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Follow clinical development from study design and recruitment through results.

Trial phase
Status
Readouts

Indications & development

Explore development by indication, patient population, and geography.

Indications
Development status
Countries

Licensing & deals

Trace asset ownership, licensing agreements, and commercial partnerships.

Partners
Deal terms
Milestones

Patents & exclusivity

Explore the patent landscape and regulatory exclusivity around an asset.

Patents
Expiration dates
Exclusivity

Competitive landscape

Compare development programs by target, modality, and indication.

Competing assets
Targets
Development stage

Research & analysis

Connect source evidence and development news to your research questions.

Publications
News
Analysis

Bring the full picture into focus.

See how Gosset can support your research on STMC-103H.

Explore the full profile