Pipeline & Science

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ABO-801 (formerly APT-1011)

A Phase 3-stage ODT candidate for eosinophilic esophagitis with FDA Orphan Drug and Fast Track Designations

About eosinophilic esophagitis

Eosinophilic esophagitis, or EoE, is a chronic, immune-mediated inflammatory disease of the esophagus. In people with EoE, progressive chronic inflammation can lead to difficulty swallowing, food impaction and changes in the structure of the esophagus over time. Current treatment approaches include dietary therapy, proton pump inhibitors, swallowed topical corticosteroids and biologic therapy. Approximately 360,000 patients in the United States have been diagnosed with EoE.

About ABO-801

ABO-801 (formerly APT-1011) is an investigational product candidate being developed for the treatment of EoE. It is a proprietary, once-daily orally disintegrating tablet (ODT) formulation of fluticasone propionate designed to deliver the corticosteroid directly to the esophageal mucosa. ABO-801 is designed to be administered once daily at bedtime and to provide localized treatment while limiting systemic exposure.

ABO-801 has been evaluated across histologic, endoscopic and symptom measures of EoE, with clinical studies evaluating treatment for up to one year. ABO-801 has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as Fast Track Designation from the FDA.

Advancing ABO-801

ABO-801 has completed two Phase 3 studies. For additional information on ABO-801’s clinical development history, view our ABO-801 Clinical History presentation. Abeona plans to advance the program through further Phase 3 development, which is expected to evaluate histologic and symptom endpoints, with patient symptom self-assessment using the Dysphagia Symptom Questionnaire (DSQ).

If approved, ABO-801 could provide a once-daily at bedtime oral treatment option for people with EoE.

ABO-801 is an investigational product candidate and has not been approved by the U.S. Food and Drug Administration or other regulatory authorities.

Metastatic prostate cancer remains a leading cause of cancer mortality, with more than 30,000 deaths annually in the U.S. despite multiple prior lines of therapy. ABO-701 (PSMA-SIR-T^™), a first-in-class engineered autologous T-cell therapy, has demonstrated in preclinical studies durable tumor control, specificity to PSMA, and a modest cytokine release profile: a favorable safety signal absent in current cell therapy approaches. Its purpose-built SIR-T^™ design is completely new, engineered to overcome the core failures of cell therapy. To learn more about SIR-T^™ click here to watch a webinar from Dr. Preet M. Chaudhary, MD PhD, Professor of Medicine and Chief of Jane Ann Nohl Division of Hematology and Center for the Study of Blood Diseases at University of Southern California (USC) Keck School of Medicine, Director of USC Blood and Marrow Transplant and Cell Therapy Program.