Zenas BioPharma Advances INDIGO Trial Enrollment in IgG4-RD

Zenas BioPharma Completes Enrollment in Phase 3 INDIGO Trial

-INDIGO is the largest clinical trial conducted in patients living with IgG4-RD-

-Topline INDIGO results expected by the end of 2025-

Zenas BioPharma, Inc. (Nasdaq: ZBIO), a pioneering clinical-stage global biopharmaceutical company, has achieved a significant milestone by completing the targeted enrollment for its Phase 3 INDIGO trial. This important clinical study is evaluating obexelimab, a promising treatment for patients suffering from Immunoglobulin G4-Related Disease (IgG4-RD).

According to Lonnie Moulder, Founder and CEO of Zenas, the completion of this enrollment showcases the company’s capability and commitment to expanding its clinical development efforts. Moulder emphasized the anticipation of topline results by the end of next year, which could move Zenas closer to establishing itself as a front-runner in immunology-based therapies.

Understanding the Phase 3 INDIGO Trial

The INDIGO trial stands as the largest clinical study focusing on IgG4-RD. This global, registration-directed, double-blind, placebo-controlled trial involves around 190 participants across 20 countries, with approximately 100 clinical sites participating. Within this trial, patients will be administered 250 mg of obexelimab or a placebo via subcutaneous injection every week for a year. Following this period, qualified participants will have the option to receive obexelimab during an open-label extension period.

The primary goal of INDIGO is to evaluate the time until the first patient experiences a flare of IgG4-RD, as determined by the clinical investigator and an adjudication committee. Secondary goals include examining the annual rate of flares, the percentage of patients achieving complete remission, and tracking the use of rescue medications.

Obexelimab: A New Hope for Autoimmune Diseases

Obexelimab is a bifunctional monoclonal antibody designed to target both CD19 and Fc?RIIb, vital components found broadly across B cell lineages. This unique therapy aims to modulate the activity of immune cells that contribute to various autoimmune diseases without completely depleting them. Obexelimab's user-friendly, self-administered injection regimen may effectively address the challenges faced by those suffering from chronic autoimmune issues.

In earlier trials, involving a total of 198 subjects who were treated either via intravenous infusion or subcutaneously, obexelimab appeared well-tolerated and showed clinical effectiveness across five studies. These encouraging results provided Zenas with an initial proof of concept that obexelimab can serve as a useful B cell inhibitor for conditions involving autoimmune responses. Currently, Zenas continues to investigate obexelimab in multiple Phase 2 and Phase 3 clinical trials focusing on various autoimmune disorders, including but not limited to IgG4-RD, Multiple Sclerosis, Systemic Lupus Erythematosus, and warm Autoimmune Hemolytic Anemia.

Challenges and Unmet Needs in IgG4-RD Treatment

IgG4-RD is a chronic inflammatory disease capable of affecting numerous organ systems, including the kidneys, lungs, pancreas, and glands. Patients may exhibit singular or multiple organ involvement, with persistent symptoms leading to serious complications. Current estimates suggest around 20,000 diagnosed cases of IgG4-RD exist in the U.S., reflecting similar rates worldwide.

Despite improvements in understanding IgG4-RD's complexity, there remain no FDA-approved treatments specifically targeting this disease. The standard approach often depends on glucocorticoids, which, while beneficial, can lead to complications and relapses shortly after discontinuation. Given the potential implications of continued B cell activity in the disease's pathogenesis, there is an urgent need for effective B cell-targeted therapies.

Existing B cell depleting therapies, such as rituximab, are sometimes used off-label among IgG4-RD patients, yet they carry risks of severe side effects and infections, which compromises patient health and immune responses.

Zenas BioPharma's Commitment to Innovative Therapies

Zenas BioPharma is uniquely positioned in the biopharmaceutical industry, with a vision to lead the development of groundbreaking immunological therapies. The company's strategic approach involves leveraging an experienced team capable of identifying and developing product candidates that provide transformative benefits to patients with autoimmune diseases.

The company's flagship treatment, obexelimab, exemplifies this innovative spirit through its dual-action mechanism, promising a new horizon for therapeutic interventions in autoimmune conditions. Patients can expect continued advancements in research and clinical trials aimed at addressing unmet needs in the autoimmune disease landscape.

Frequently Asked Questions

What is the Phase 3 INDIGO trial about?

The Phase 3 INDIGO trial evaluates the safety and efficacy of obexelimab in patients with IgG4-RD, aiming to address unmet medical needs in this disease area.

What are the expectations for the INDIGO trial results?

Topline results from the INDIGO trial are anticipated to be released by the end of next year.

What makes obexelimab different from other treatments?

Obexelimab is a bifunctional monoclonal antibody targeting both CD19 and Fc?RIIb, allowing it to modulate immune responses without depleting B cells.

How many patients are enrolled in the INDIGO trial?

The INDIGO trial involves approximately 190 patients across around 100 sites in 20 different countries.

Why is IgG4-RD treatment important?

IgG4-RD is a chronic, potentially debilitating disease with high unmet medical needs, and effective treatments have not been approved for this condition.

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