DB-2304 / DualityBio - LARVOL DELTA

DB-2304-101: A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants (clinicaltrials.gov) - P1/2 | N=148 | Recruiting | Sponsor: DualityBio Inc. | Trial completion date: Jun 2026 ➔ Dec 2027 | Trial primary completion date: Mar 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DB-2304-101: A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE Participants (clinicaltrials.gov) - P1/2 | N=148 | Recruiting | Sponsor: DualityBio Inc. | Phase classification: P1 ➔ P1/2 | N=106 ➔ 148

Enrollment change • Phase classification • Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DB-2304-101: A Phase 1 Study of DB-2304 in Healthy Adults and SLE Participants (clinicaltrials.gov) - P1 | N=106 | Recruiting | Sponsor: DualityBio Inc. | Not yet recruiting ➔ Recruiting | N=70 ➔ 106

Enrollment change • Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DB-2304, an Immunomodulatory Antibody‒drug Conjugate (ADC) Targeting BDCA2, Displays Strong In Vivo Efficacy in Pharmacodynamic and Psoriasis Models (ACR Convergence 2024) - "It also reduced pDC cell surface BDCA2 level in an ADC serum concentration-dependent manner and inhibited pathogenesis in Imiquimod induced psoriasis in cynomolgus monkey. DB-2304 has clearly demonstrated greater in vitro and in vivo potency with synergistic effects on the regulation of both type I interferon genes and proinflammatory cytokines in pDCs. Taken together, these data support the clinical investigation of DB-2304 in the future."

Immunomodulating • PK/PD data • Preclinical • Dermatology • Immunology • Inflammatory Arthritis • Lupus • Psoriasis • Systemic Lupus Erythematosus