Concerto Biosciences Doses First Participant in Phase 1 Trial of ENS-002, a Microbiome-Based Therapy for Atopic Dermatitis

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Concerto Biosciences recently announced that the first participant has been dosed in its phase 1 trial of ENS-002, a microbiome-based therapeutic solution, for atopic dermatitis (AD).¹

This live biotherapeutic is being developed to address AD by targeting Staphylococcus aureus (S. aureus), a bacterium closely linked to inflammation in the condition. The trial, titled Topical ENS-002 for Atopic Dermatitis in Adults (EnSync), could mark a step forward in microbiome-driven dermatologic treatments.

ENS-002 is a topical therapy comprised of 3 carefully selected strains of microbes. These strains work together to suppress the virulent behavior of S. aureus, which is often found in disproportionate levels on the skin of patients with AD.² Unlike current treatments—such as corticosteroids, calcineurin inhibitors, and systemic immunosuppressants—ENS-002 does not focus on suppressing the immune system. Instead, it seeks to restore balance to the skin microbiome.

ENS-002 was developed using Concerto's proprietary kChip technology, a platform that enables the screening of millions of microbial combinations to uncover functional synergies. This screening process generates datasets on microbial interactions.

For ENS-002, over 6 million microbial communities were analyzed to identify the optimal combination capable of pacifying pathogenic S. aureus.

The phase 1 trial will enroll 9 participants in 3 dose-escalation cohorts, testing increasing concentrations and application frequencies of ENS-002. The primary objectives are to evaluate the therapy’s safety and tolerability. Secondary endpoints will assess its impact on S. aureus abundance and its ability to improve clinical symptoms of AD.

Clinical trial sites are currently open for enrollment, and Concerto plans to share safety and preliminary proof-of-mechanism data in 2025. The trial is registered under ClinicalTrials.gov (NCT06469385).³

"This clinical milestone marks a promising step forward not only in managing a challenging skin condition but also in demonstrating the potential of precisely selected microbial combinations to address complex diseases rooted in microbiome deficiencies," said Cheri Ackerman, CEO of Concerto Biosciences, in a news release.¹ "Demonstration of this therapeutic approach could change the way we think about the mechanisms and therapeutic possibilities in a wide variety of diseases."

References

1. Concerto Biosciences announces first participant dosed with live biotherapeutic ENS-002 in phase 1 trial for atopic dermatitis. News release. PR Newswire. November 19, 2024. Accessed November 19, 2024. https://www.prnewswire.com/news-releases/concerto-biosciences-announces-first-participant-dosed-with-live-biotherapeutic-ens-002-in-phase-1-trial-for-atopic-dermatitis-302310102.html
2. Iwamoto K, Moriwaki M, Miyake R, Hide M. Staphylococcus aureus in atopic dermatitis: Strain-specific cell wall proteins and skin immunity. Allergol Int. 2019;68(3):309-315. doi:10.1016/j.alit.2019.02.006
3. Topical ENS-002 for Atopic Dermatitis in Adults (EnSync). ClinicalTrials.gov identifier: NCT06469385. Updated July 23, 2024. Accessed November 19, 2024. https://clinicaltrials.gov/study/NCT06469385?tab=history