Concerto Biosciences has dosed the first subject in a Phase I trial of the three-stain live biotherapeutic product, ENS-002, aimed at treating atopic dermatitis.
ENS-002 is being developed for atopic dermatitis by targeting Staphylococcus aureus (S. aureus), which is a key skin inflammation driver.
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Concerto Biosciences leveraged its screening technology, kChip, for the discovery of ENS-002. This platform can screen millions of microbial combinations, creating a vast dataset of microbial interactions. These data provide precise, predictive insights into microbial behaviour.
The first-in-human study is set to enrol approximately nine participants across three cohorts. These cohorts will receive increasing dose concentrations and frequencies to assess the product’s safety, tolerability, and efficacy in controlling S. aureus and treating atopic dermatitis.
Clinical trial sites for topical ENS-002 for atopic dermatitis in adults (EnSync) are currently open for enrolment.
In June this year, the US Food and Drug Administration (FDA) accepted the investigational new drug (IND) application, allowing the Phase I trial of Ensemble No.2 (ENS-002) to proceed.
The hypothesis behind ENS-002’s development stemmed from insights into the role of the skin’s microbial ecology in atopic dermatitis.
Using kChip, the company identified three microbial strains that synergistically encourage S. aureus to transition from a harmful state to a more benign one after generating over six million unique microbial combinations.
Concerto Biosciences CEO Cheri Ackerman said: “For the millions of people who suffer from atopic dermatitis (AD), or eczema, ENS-002 represents a potential paradigm shift in care.”
“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.
“Demonstration of this therapeutic approach could change the way we think about the mechanisms and therapeutic possibilities in a wide variety of diseases.”
