EGL-003 / Egle Therap - LARVOL DELTA

Egle Therapeutics to Present Clinical Data at the Upcoming European Academy of Dermatology and Venereology (EADV) Congress in Vienna (The Manila Times) - "The data to be presented includes safety and pharmacodynamic data from its recently completed Phase 1 Single Ascending Dose (SAD) study in healthy volunteers and supports the clinical rationale for EGL-003, the company's Treg-selective IL-2 agonist, and its advancement to the next stage of clinical development."

First-in-human • P1 data • Immunology

EGL-003 First in human study: An IL-2 Mutein inducing potent and selective amplification of Treg with preferential activation of effector/memory skin homing Tregs (EADV 2026) - No abstract available

First-in-human • P1 data • Immunology • IL2

EGL-003: a novel Treg biased IL-2 mutein conserving full agonism mobilizes Tissue Regulatory T Cells and Resolves Inflammation (ESDR 2026) - No abstract available

Inflammation • IL2

EGL-311: A first-in-human, open-label, dose finding study to evaluate the safety, tolerability and pharmacokinetics of EGL-003 in healthy volunteers followed by adults with autoimmune disease. (clinicaltrialsregister.eu) - P1 | N=58 | Recruiting | Sponsor: Egle Therapeutics

First-in-human • New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Egle Therapeutics Initiates Phase 1 Healthy Volunteer Study of EGL-003, a Next Generation Treg IL-2 Agonist for Atopic Dermatitis (Businesswire) - "The open-label, multi-center Phase 1 trial begins with a single ascending dose portion in healthy volunteers to rapidly generate foundational safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. These findings will inform dose selection and scheduling for the subsequent multiple ascending dose portion in approximately 40 adults with atopic dermatitis (AD), which will evaluate safety, PK/PD, and early clinical activity versus placebo. Data from both study segments are expected to guide dose selection for a planned Phase 2a trial in AD aimed at establishing clinical proof of concept...'We look forward to translating this profile into human PK/PD data and advancing toward patient studies in early 2026'."

New trial • Trial status • Atopic Dermatitis

EGL-003: an optimized IL-2 mutein designed to expand regulatory T cells for the treatment of autoimmune diseases (EULAR 2025) - "EGL-003 is a novel IL-2 mutein Fc-fusion protein with potent, selective Treg-expanding activity and demonstrated safety and activity in preclinical models. These findings support its clinical evaluation for autoimmune diseases."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Lupus • Renal Disease • CD8 • FCGR2A • FCGR2B • GATA3 • IL2 • IL2RG • ISG20 • PTPRC • ST2 • STAT5 • STAT5AWqe

Egle Therapeutics to share preclinical data for its first autoimmune disease program, EGL-003, with an oral presentation at the 2024 Promise of Interleukin-2 Therapy Meeting (Businesswire) - "Egle Therapeutics...will deliver an oral presentation at The Promise of Interleukin-2 Therapy meeting taking place in Paris from September 4th to 7th, 2024. The presentation...will show evidence that EGL-003, a non-targeted Fc-fused IL-2 agonist mutein, selectively binds to regulatory T cells (Treg) and induces Treg IL-2 signaling. The resulting increase of Treg frequencies was observed in vitro and in different mouse models. Accordingly, EGL-003 significantly improved clinical, macroscopic, and histological parameters in a DSS-induced colitis mouse model with expansion of tissue-resident Tregs."

Preclinical • Immunology