Concerto Biosciences, based in Cambridge, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin Phase 1 trials of Ensemble No.2 (ENS-002), a novel live biotherapeutic product (LBP) designed for treating atopic dermatitis (AD). Developed using Concerto's proprietary screening technology called kChip, ENS-002 represents a potential breakthrough in AD treatment.

Concerto Biosciences, emphasized the significance of ENS-002 in offering a new therapeutic approach for AD patients. Traditionally, AD patients have had to manage their condition with topical treatments or undergo costly immune-modulating therapies. ENS-002 aims to provide a more innovative microbial therapy option. Ackerman also noted that the FDA clearance is a significant milestone for Concerto Biosciences and for advancing microbial therapeutics, enhancing understanding of how skin microbiomes affect health.

The development of ENS-002 was guided by insights into the role of skin microbiota in AD, particularly their impact on S. aureus proliferation and skin inflammation. Using kChip, Concerto screened over 6 million microbial combinations to identify three strains that work synergistically to counteract S. aureus, potentially reducing its harmful effects.

Concerto Biosciences, highlighted the favorable characteristics of ENS-002 as an ideal microbial product: nonpathogenic, derived from healthy human skin, and not genetically modified. ENS-002 will be administered topically and is expected to act locally, requiring minimal physician oversight and posing fewer immunosuppressive risks compared to other AD therapies.

Bernardo Cervantes, COO and Co-founder, expressed pride in Concerto's team for advancing ENS-002 from concept to FDA-approved clinical trial within a short timeframe of four years. With ENS-002 leading the way, Concerto looks forward to further innovations from its kChip platform to benefit patients seeking effective AD treatments.

 

Source: prnewswire.com

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