EQUALISE Phase 1b Study in lupus nephritis fully enrolled – topline data in early 2024

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that abstracts were accepted for poster presentations at the annual meetings of the American Society of Nephrology (ASN) and the American College of Rheumatology (ACR). ASN is taking place at the Pennsylvania Convention Center in Philadelphia, PA, November 1 – 5, and ACR is taking place at the San Diego Convention Center in San Diego, CA, November 10 - 15.

The abstracts highlight data from 17 Type B subjects in the Phase 1B EQUALISE study in highly proteinuric lupus nephritis patients (mean 24-hour urine protein creatinine ratio (UPCR) > 4 g/day). The data demonstrate that subjects had high complete and partial response rates with rapid and deep reduction in UPCR when itolizumab was added to mycophenolate mofetil and corticosteroids. This is in the setting of tapering the corticosteroids, stable kidney function (eGFR) and increasing serum albumin while on study. Itolizumab was well tolerated when treated every 2 weeks for 24 weeks; with only 2 subjects reporting serious adverse events.

American Society of Nephrology American College of Rheumatology

Title: EQUALISE Type B: Clinical results of itolizumab, a novel anti-CD6 therapy, in subjects with lupus nephritis

Author: Dr. Kenneth Kalunian, Professor, Medicine, UCSD School of Medicine

Poster Number: SA-PO875

Assigned Session: Glomerular Diseases: Therapeutics

Date and Time: November 4, 10:00 am ET – 12:00 pm ET

American College of Rheumatology

Title: Clinical Safety and Efficacy Results from EQUALISE Type B: A Phase 1b Open-label Clinical Study of Itolizumab, a Novel anti-CD6 Therapy, in Subjects with Active Proliferative Lupus Nephritis

Author: Dr. Kenneth Kalunian, Professor, Medicine, UCSD School of Medicine

Abstract Number: 1496

Assigned Session: SLE – Treatment Poster II

Date and Time: November 13, 9:00 am ET – 11:00 am PT

The abstracts are available on the ASN website and ACR website. Poster presentations will be available on the Presentations page of Equillium’s website under the Lupus tab.

About Systemic Lupus Erythematosus (SLE) & Lupus Nephritis (LN)

SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. LN is a serious complication of SLE, occurring in approximately 30% – 60% of individuals with SLE. LN involves the body’s own immune system attacking the kidneys, causing inflammation and significantly reducing kidney function over time. LN is associated with an increase in mortality compared with the general population and may lead to end-stage renal disease.

About the EQUALISE Study

The EQUALISE study is a two-part Phase 1b open-label proof-of-concept study of itolizumab in patients with SLE and LN. The Type A portion of the study was a multiple ascending-dose clinical study evaluating the safety and tolerability of subcutaneous delivery of itolizumab over a two-week treatment period in 35 patients with SLE. The Type B portion of the study, currently enrolling, is evaluating the safety, tolerability and clinical activity of subcutaneous delivery of itolizumab dosed at 1.6 mg/kg every two weeks over a 24-week treatment period in up to 20 patients with active proliferative LN.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to selectively downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases.

About Equillium

Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets targeting immuno-inflammatory pathways. EQ101: a tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ102: a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21; currently under evaluation in a Phase 1 first-in-human clinical study to include healthy volunteers and celiac disease patients. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and a Phase 1b clinical study of patients with lupus/lupus nephritis. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited and has entered a strategic partnership with Ono Pharmaceutical Co., Ltd. for the development and commercialization of itolizumab under an option and asset purchase agreement.

For more information, visit www.equilliumbio.com.

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