Concerto Biosciences Receives FDA Investigational New Drug Clearance for Live Biotherapeutic Product to Treat Atopic Dermatitis

CAMBRIDGE, Mass.—(PR NEWSWIRE)—Concerto Biosciences, a Cambridge-based biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1, first-in-human trial of Ensemble No.2 (ENS-002), an investigational live biotherapeutic product (LBP) to treat atopic dermatitis (AD). The company discovered ENS-002 with kChip, its powerful, proprietary screening technology for identifying microbial, prebiotic, and postbiotic product candidates.

“ENS-002 represents a potential new treatment paradigm for AD patients, who are typically choosing between playing ‘whack-a-mole’ with topicals for each flare or a lifelong journey with intense and expensive immune modulators,” said Cheri Ackerman, CEO and Cofounder of Concerto Biosciences. “The IND clearance for ENS-002 is also an important moment for the field of microbial therapeutics. As an industry, we’ve been striving to understand how individual microbial members work together within ecosystems that shape our health. A deeper look into this ecology, something that Concerto’s kChip uniquely achieves, could unlock the therapeutic benefits of the microbial world.”

The discovery of ENS-002 began with recent insights that the microbial ecology of the skin is implicated in AD: Absent certain protective skin microbiome functions, the bacterium S. aureus proliferates uncontrollably and produces virulence factors that degrade and inflame skin. Concerto hypothesized that administration of a carefully chosen set of bacteria could placate S. aureus and thereby treat AD. Using kChip, Concerto generated over 6 million distinct combinations of skin-dwelling microbes to identify a group of three strains that work in a synergistic fashion to move S. aureus away from its aggressive, disease-causing state into a docile state.

“Concerto is proud to debut ENS-002, which has all the qualities of an ideal microbial product. All the strains are nonpathogenic, clonal, derived from healthy human skin, and not genetically modified,” said Lou Vaickus, MD, Interim CMO of Concerto Biosciences. “ENS-002 will be applied topically, act locally, and will likely require little to no physician monitoring. It is not expected to be immunosuppressive, so we don’t expect to see systemic immune-related side effects like increased risk of infection or cancer, problems that may occur with other AD therapies. We are eager to see how ENS-002 performs in the upcoming clinical trial. Not only does the FDA’s clearance of ENS-002 for human trials demonstrate that Concerto is ready to bring its products into the clinic, but we are one step closer to bringing an innovative treatment modality to patients.”

From a concept on paper in 2020 to FDA clearance for its first clinical trial in 2024, Concerto has demonstrated strong acceleration and maturation over a short period of time. “We are tremendously proud of our team and the work they’ve accomplished to bring ENS-002 to the clinic with such rigor and efficiency,” said Bernardo Cervantes, COO and Cofounder of Concerto Biosciences. ENS-002 is the first product to come from Concerto’s kChip discovery platform, and with continued advancements, more products will follow in its footsteps.