AT-02 / Attralus - LARVOL DELTA

Renal responses in a phase 1/2 study of at-02, a novel pan-amyloid depleter ig fusion protein for the treatment of patients with AL amyloidosis (ASH 2025) - "Improvements in eGFR were observed in participantswith kappa or lambda iFLC, in participants with hematologic VGPR or CR and in participants withhematologic responses ranging from 1-6 years prior to initiating AT-02 treatment.One participant in the q2w dose cohort also met the proteinuria criteria with a baseline uACR 1349 mg/g.uACR decreased by 70% and 84% following 8 and 40 weeks of treatment with AT-02 2500 mg q2w,respectively. The early rapid decline in uACR was followed by a slower progressive decline over thetreatment period.No renal evaluable AL participant developed new or worsening proteinuria.ConclusionThese initial data support the potential for AT-02, a novel pan-amyloid depleting Ig fusion protein, toimprove renal function in AL patients with renal disease who have achieved hematologic response."

Clinical • P1/2 data • Amyloidosis • Cardiac Amyloidosis • Cardiovascular • Chronic Kidney Disease • Nephrology • Renal Disease

Attralus Therapeutic AT-02 Receives Orphan Drug Designation from the U.S. FDA for the Treatment of ATTR Amyloidosis (GlobeNewswire) - "Attralus, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for AT-02 for the treatment of transthyretin-associated amyloidosis (ATTR), a rare, progressive, debilitating and often fatal condition."

Orphan drug • Amyloidosis • Metabolic Disorders

Attralus Receives European Medicines Agency Committee for Orphan Medicinal Products (COMP) Positive Opinions for AT-02 for the Treatment of Both ATTR and AL Amyloidosis (GlobeNewswire) - "Attralus, Inc...announced today that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions for orphan medicinal product designations for AT-02 for the treatment of the two most common forms of systemic amyloidosis, transthyretin-associated amyloidosis (ATTR) and immunoglobulin light-chain-associated (AL) amyloidosis."

European regulatory • Amyloidosis • Metabolic Disorders

AT02-001: Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Attralus, Inc. | Trial completion date: Mar 2024 ➔ Mar 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Amyloidosis

A Study of AT-02 in Subjects With Systemic Amyloidosis. (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Attralus, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Amyloidosis • NPPB

The Peptide Fusion Immunoglobulin, AT-02, Exhibits Highly Potent Pan-Amyloid Reactivity And Immunomodulation (HFSA 2023) - "Clearance of cardiac amyloid is a significant clinical unmet need for patients with systemic amyloidosis. The humanized IgG1-peptide fusion, AT-02, potently binds cardiac amyloid, inhibits fibril growth and may serve as an effective opsonin to induce the macrophage-mediated phagocytosis and clearance of cardiac amyloid deposits."

Immunomodulating • Amyloidosis • Cardiac Amyloidosis • Cardiomyopathy • Cardiovascular • Hypertrophic Cardiomyopathy • Immunology

A Study of AT-02 in Subjects With Systemic Amyloidosis. (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Attralus, Inc. | N=80 ➔ 120

Enrollment change • Amyloidosis • NPPB

A Study of AT-02 in Subjects With Systemic Amyloidosis. (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Attralus, Inc.

New P2 trial • Amyloidosis • NPPB

AT02-001: Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Attralus, Inc. | N=39 ➔ 100 | Trial completion date: Sep 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2023 ➔ Mar 2024

Enrollment change • Trial completion date • Trial primary completion date • Amyloidosis

AT02-001: Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Attralus, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Amyloidosis

AT02-001: Study of AT-02 in Healthy Volunteers and Subjects With Systemic Amyloidosis (clinicaltrials.gov) - P1 | N=39 | Not yet recruiting | Sponsor: Attralus, Inc.

New P1 trial • Amyloidosis