Egle Therapeutics Initiates Phase 1 Healthy Volunteer Study of EGL-003, a Next Generation Treg IL-2 Agonist for Atopic Dermatitis

Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company developing precision medicines that modulate regulatory T cells (Tregs) to restore immune balance, today announced dosing of the first healthy volunteer in the Phase 1 clinical study of EGL-003, an IL‑2⍺-biased mutein designed to selectively activate Tregs while limiting effector T cell stimulation, as a potential treatment for atopic dermatitis.

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. EGL-003’s Treg-selective design may also support expansion into additional autoimmune diseases where durable immune recalibration is needed.

“Dosing the first participants in this study marks an important step for EGL-003,” said Kenji Hashimoto, MD, PhD, Chief Medical Officer of Egle Therapeutics. “Preclinical data show a critical combination of both potent Treg engagement and an extensive Treg-selective window compared with legacy IL‑2 approaches. We look forward to translating this profile into human PK/PD data and advancing toward patient studies in early 2026.”

About Atopic Dermatitis

Atopic dermatitis (AD) is a common, chronic inflammatory skin disease with significant patient burden, including itch, sleep disruption, visible lesions, and quality of life impacts, especially in moderate to severe cases. In the U.S. and EU combined, there are an estimated 21.2 million addressable moderate to severe AD patients. Current treatments span topicals, phototherapy, systemic immunomodulators, and targeted biologics/JAK inhibitors; however, many patients do not achieve sustained control, resulting in unmet needs for new treatment options that can provide long-term remission and quality of life gains.

About EGL-003

EGL-003 is a next-generation IL-2 mutein engineered for potent, selective activation of regulatory T cells while sparing conventional effector T cells. It maintains IL-2-like full agonism on Tregs and features a pharmacokinetic profile designed to deliver intermittent, physiological bursts of signaling, similar to wild type IL-2. In preclinical models, EGL-003 increased tissue-resident, tissue-healing Tregs and improved inflammatory disease readouts, demonstrating mechanistic and functional differentiation from earlier IL-2 approaches. EGL-003 is being evaluated in atopic dermatitis with the potential to expand into additional autoimmune indications.

About Egle Therapeutics

Egle Therapeutics is a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer. The company’s proprietary technology platform enables the engineering of highly selective IL-2 variant immuno-conjugates which are designed to overcome the efficacy and safety limitations of previous Treg-focused therapies. Its autoimmunity portfolio is led by EGL-003, an IL-2 agonist Treg engager currently being explored as a potential treatment for atopic dermatitis and other autoimmune diseases. Egle’s immuno-oncology portfolio includes EGL-001, an anti-CTLA-4-IL-2m fusion which has implemented its first-in-human dosing, and EGL-002, an anti-CCR8 x anti-CD25 bispecific. For more information, visit www.egle-tx.com and follow us on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251202739016/en/