As many as four percent of the world’s population lives with an autoimmune disease, in which the immune system fails to distinguish between ‘self’ and ‘non-self’ and mistakenly attacks the body, resulting in tissue damage.1 There are more than 80 types of autoimmune diseases, affecting multiple tissues and organs. These conditions are chronic with symptoms that wax and wane, impacting quality of life for the people living with them.2
Chronic inflammatory demyelinating polyneuropathy (CIDP) is one such life-altering condition, affecting approximately 9 in 100,000 people in the US.3 Evidence suggests that one key mechanism of disease in CIDP involves harmful Immunoglobulin G (IgG) antibodies attacking the protective layer of the nerves, known as the myelin sheath, resulting in peripheral nerve damage. Symptoms include fatigue, muscle weakness of the arms or legs, tingling or numbness, loss of reflexes, and abnormal sensations.
Although symptoms may develop slowly, CIDP is a chronic, progressive condition that can lead to loss of arm and leg function. Because there is no specific test for CIDP and the initial symptoms are similar to other diseases that affect the nervous system, it can sometimes take years for someone to receive a CIDP diagnosis. At the same time, misdiagnosis is common, with up to 50 percent of people with suspected CIDP experiencing nerve issues (neuropathy) or other “CIDP-like” symptoms due to a different underlying cause.4
People with CIDP often require ongoing treatment, typically with intravenous immunoglobulin (IVIG) or plasma exchange administered in a hospital or infusion center, and/or oral and systemic steroids. Although some individuals respond well to this standard of care, many struggle with side effects, the burdensome nature of treatment, and inconsistent disease control. In addition, people may experience treatment interruptions or adjustments due to potential IVIG supply shortages or decreased plasma donations used to develop IVIG therapies. The CIDP treatment landscape highlights the opportunity for new, targeted therapies that help address the underlying drivers of disease.
Immunovant, a company dedicated to enabling normal lives for people with autoimmune diseases, is driving clinical research in CIDP to both advance scientific understanding of the disease and develop a new targeted therapy to better meet the needs of people with CIDP and the healthcare professionals who treat them.
Pioneering new anti-FcRn treatment options
Immunovant’s investigational therapy, batoclimab, is a fully human monoclonal antibody designed to block the neonatal Fc receptor (FcRn) to reduce harmful IgG antibodies. This has the potential to alleviate symptoms in CIDP and other autoimmune diseases. Batoclimab has several attributes that may help address unmet needs: an observed rapid and deep IgG reduction of up to 78 percent in a Phase 1 study,5 subcutaneous formulation that can potentially be self-administered at home, and tailored dosing options to address varying symptom severity and stage of disease.
Tailoring trial design to address challenges unique to CIDP
In addition, the company is applying key learnings from previous and ongoing CIDP trials to answer critical scientific questions about the biology of CIDP and how disease management may be optimized in the future. Recognizing the various challenges with appropriate diagnosis, its Phase 2b trial of batoclimab includes: 1) the use of a diagnostic algorithm that aims to help ensure all trial participants have confirmed CIDP, and 2) three separate patient enrichment strategies designed to select participants with active, progressive CIDP who are more likely to respond to treatment. In addition, multiple doses are being studied to help identify the optimal dosing regimen, which may be a standard dosing regimen for some and might be a higher dosing regimen for others. Finally, the trial is purposely designed to analyze participants with different treatment histories separately, to help researchers more clearly understand what types of people with CIDP will benefit from anti-FcRn treatment and inform future clinical trial design.
Reframing expectations for people with autoimmune disorders
Immunovant is focused on developing anti-FcRn therapies to offer targeted treatment options for people with CIDP and other autoimmune disorders. Its rich development portfolio, which also includes a second-generation anti-FcRn investigational therapy, currently comprises clinical programs for myasthenia gravis, thyroid eye disease, and Graves’ disease.
To learn more about Immunovant and its commitment to leading a new era of care for people with autoimmune diseases, visit Immunovant.com.
1. National Stem Cell Foundation. Autoimmune Disease. Available at: nationalstemcellfoundation.org/glossary/autoimmune-disease/. Accessed January 2023.
2. National Library of Medicine. Autoimmune diseases. Available at: https://medlineplus.gov/autoimmunediseases.html. Accessed January 2023.
3. Mathey EK, Park SB, Hughes RAC, et al Chronic inflammatory demyelinating polyradiculoneuropathy: from pathology to phenotype. Journal of Neurology, Neurosurgery & Psychiatry 2015
4. Allen, J. The Misdiagnosis of CIDP: A Review. Neurol Ther. 2020 Feb 11; 9:43-54.
5. Collins J et al. Presented at the AAN 2019 Virtual Annual Meeting; May 4-10, 2021: P5-079.
6. Image by pch.vector on Freepik