ENS-002 / Concerto Biosci - LARVOL DELTA

Concerto Biosciences Announces Positive Topline Results from Phase 1b Clinical Trial of ENS-002 in Patients with Atopic Dermatitis (PRNewswire) - "Both cohorts showed reductions in eczema severity during the 1–2 weeks of administration that persisted through the post-administration phase. Overall, Eczema Area and Severity Index (EASI) improved in 3/4 participants in Cohort 1 (lower dose) and 4/4 participants in Cohort 2 (higher dose); and peak pruritus decreased in 2/4 participants in Cohort 1 and in 4/4 participants in Cohort 2....On treated S. aureus–positive lesions, S. aureus levels fell sharply-often to near zero-and no new S. aureus growth appeared on previously negative or untreated skin....Concerto plans to conduct vehicle-controlled clinical assessments of ENS‑002 safety and efficacy across adult and pediatric patients."

P1 data • Atopic Dermatitis

EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov) - P1 | N=9 | Terminated | Sponsor: Concerto Biosciences | Recruiting ➔ Terminated; Planned safety, efficacy and proof of mechanism obtained

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Concerto Biosciences | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CRP

Concerto Biosciences Announces First Participant Dosed with Live Biotherapeutic ENS-002 in Phase 1 Trial for Atopic Dermatitis (PRNewswire) - "Concerto Biosciences...today announced the first participant has been dosed in their Phase 1, first-in-human trial of ENS-002, a three-strain live biotherapeutic product being developed to address atopic dermatitis by targeting Staphylococcus aureus (S. aureus), a key driver of skin inflammation....Concerto anticipates being able to report safety and preliminary proof of mechanism data in 2025."

P1 data • Trial status • Atopic Dermatitis

EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Concerto Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CRP

EnSync: Topical ENS-002 for Atopic Dermatitis in Adults (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: Concerto Biosciences

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • CRP

Concerto Biosciences Receives FDA Investigational New Drug Clearance for Live Biotherapeutic Product to Treat Atopic Dermatitis (PRNewswire) - "Concerto Biosciences...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)....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."

IND • Atopic Dermatitis • Immunology