The company's first product is a synergistic
combination of topical bacteria that may treat atopic
dermatitis.
CAMBRIDGE, Mass., June 26,
2024 /PRNewswire/ -- 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.
About Concerto Biosciences
Concerto Biosciences examines the microbial world with unmatched
experimental depth to discover breakthrough microbe-based products.
Concerto draws inspiration from microbial ecology: Microbes all
around us work in concert to improve human health, enhance food
quality, and boost crop yield. Designing products that recreate
these capabilities requires an unprecedented understanding of how
microbes behave together. Concerto unlocks this knowledge with
kChip, a discovery engine that physically constructs millions of
miniature, defined microbial communities simultaneously. By
observing the behavior of each community, Concerto rapidly
identifies the most promising microbes, prebiotics, and postbiotics
for development into new products. In its first endeavor, Concerto
constructed >6 million communities of skin-dwelling microbes to
discover an eczema-alleviating "ensemble" of bacteria that pacifies
pathogenic S. aureus. Concerto has since initiated discovery
projects in a diversity of areas including women's health and
agriculture. In partnership with a diverse array of biotech and
biopharma companies, Concerto aims to unleash a new era of
microbial research and microbe-based products.
To learn more about Concerto Biosciences,
visit www.concertobio.com. Follow us at
concerto-biosciences.
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SOURCE Concerto Biosciences