LAPIX Therapeutics Announces First Patient Dosed in Phase Ib Study of LPX-TI641 in Atopic Dermatitis

Study Evaluates New Oral Capsule Formulation in a Th2-Dominant Inflammatory Disease

CAMBRIDGE, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a clinical-stage biopharmaceutical company developing first-in-class, orally delivered immune-tolerance-restoring therapies, announced today that the first patient has been dosed in its Phase Ib clinical study of LPX-TI641 in adults with atopic dermatitis (AD).

The Phase Ib study evaluates LPX-TI641 in a chronic inflammatory disease characterized by Th2-mediated immune dysregulation, extending the company’s prior clinical work in autoimmune indications. The study utilizes LAPIX’s new oral capsule formulation, which demonstrated improved systemic exposure and favorable tolerability in recent bioequivalence studies that is now being used across all active clinical programs, including rheumatoid arthritis and atopic dermatitis.

Advancing Clinical Evaluation of LPX-TI641 in Th2-Dominant Inflammation

Previous LAPIX clinical studies have focused on autoimmune diseases driven primarily by Th1- and Th17-mediated immune dysfunction. In contrast, atopic dermatitis is characterized by Th2-dominant inflammation, skin barrier impairment, and persistent immune activation. Preclinical data supporting agonism of the TIM family of receptors across multiple immune pathways—including expansion of regulatory T and B cell populations and modulation of pathogenic effector responses—provide the scientific rationale for evaluating LPX-TI641 in this disease setting.

“Dosing the first patient in our Phase Ib atopic dermatitis study represents an important clinical milestone for LAPIX,” said Anas M. Fathallah, Ph.D., co-founder and chief executive officer of LAPIX Therapeutics. “This study allows us to evaluate LPX-TI641 in a distinct immunologic context and to further characterize its safety, pharmacokinetics, and biomarker profile using our optimized oral capsule formulation.”

About the Phase Ib Atopic Dermatitis Study

The Phase Ib study (NCT06982352) is a randomized, placebo-controlled trial evaluating the safety, tolerability, and pharmacokinetics of LPX-TI641 in adult patients with mild-to-moderate atopic dermatitis. Exploratory biomarkers related to immune tolerance and modulation of Th2-associated inflammation will also be assessed. Data from the study are expected to inform indication expansion beyond autoimmune diseases and guide the design of subsequent Phase II clinical studies.

About LPX-TI641

LPX-TI641 is an oral, small-molecule designed to bind the T cell/transmembrane, immunoglobulin, and mucin (Tim) family of receptors. It is currently under clinical development for autoimmune indications such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO) and other autoimmune indications where the underlying pathology involves immune imbalances and loss of self-tolerance. LPX-TI641 aims to re-establish immune balance without broad immunosuppression, offering a differentiated therapeutic approach across autoimmune and inflammatory diseases.

About LAPIX Therapeutics

LAPIX Therapeutics is a Cambridge, MA-based clinical-stage biopharmaceutical company focused on developing novel, first in class, oral immune system restoration therapeutics for the treatment of autoimmune diseases. Our scientific approach to developing Tim agonists (T-cell immunoglobulin and mucin domain) and restoring the natural immune tolerance pathway with potent small molecules reflects our commitment to progressive and patient-centric therapies.

Media Contact:
Anas M. Fathallah, Ph.D.
CEO & Co-Founder
LAPIX Therapeutics
info@lapixtherapeutics.com