Product Dev Landscape
Potential Platform to Treat Multiple Autoimmune Diseases
‘1805 is a modified analogue of the endogenous immune-regulatory binding immunoglobulin protein (BiP), a key player in immune function that resets the immune system for long-term disease remission. Its mechanism of action creates vast optionality across multiple indications and routes of administration.
We are developing ‘1805 for the treatment of patients with moderate to severe rheumatoid arthritis (RA) and ulcerative colitis (UC) while exploring additional indications.
RA is a chronic inflammatory disease that is currently one of the largest therapeutic segments worldwide, affecting roughly 1.3 million people in the US alone.1
Steroids, immunosuppressants, and biologics are available, but these treatment options suppress the immune system,2 putting patients at risk of serious infections and other complications. Additionally, 60 to 70% of patients do not achieve remission,3 and ~20% of patients do not respond4 to available therapies.
Patients with RA need improved therapies that achieve long-lasting remission without unwanted side effects.
A Phase 2 trial investigating ‘1805 as a potential treatment for patients with moderate to severe RA is in preparation.
Non-infectious Uveitis (NIU)
NIU, or inflammation of the inside of the eye, is a leading cause of adult blindness in western countries,7 affecting about 300,000 patients annually8 in the US. Untreated, NIU can cause vision loss in up to 40% of patients, interfering with productivity and negatively impacting quality of life.
Out of the approximately 100,000 patients with NIU treated every year, roughly 50% are nonresponsive to the only approved biologic. Steroids remain the mainstay of therapy but can lead to unwanted ocular and systemic side effects. Most patients are unable to achieve long-term disease remission with available treatments.
A Phase 2 trial investigating ‘1805 as a potential treatment for patients with NIU is expected to start soon.
- Helmick CG, Felson DT, Lawrence RC, et al; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;58(1):15-25.
- American Academy of Allergy, Asthma & Immunology. Immunosuppressive medication for the treatment of
autoimmune disease. https://www.aaaai.org/conditions-and-treatments/related-conditions/
immunosuppressive. Accessed April 5, 2021.
- Brown PM, Isaacs JD. Rheumatoid arthritis: from palliation to remission in two decades. Clin Med (Lond).
- de Hair MJH, Jacobs JWG, Schoneveld JLM, van Laar JM. Difficult-to-treat rheumatoid arthritis: an area of unmet
clinical need. Rheumatology (Oxford). 2018;57(7):1135-1144.
- Brownlie RJ, Myers LK, Wooley PH, et al. Treatment of murine collagen-induced arthritis by the stress protein
BiP via interleukin-4-producing regulatory T cells: a novel function for an ancient protein. Arthritis Rheum.
- Kirkham, B et al. 2016. Safety and patient response as indicated by biomarker changes to binding
immunoglobulin protein in the phase I/IIA RAGULA clinical trial in rheumatoid arthritis. Rheumatology, vol 55 (11):
- Rosenbaum JT, Bodaghi N, Couto C, et al. New observations and emerging ideas in diagnosis and management
of non-infectious uveitis: A review. Semin Arthritis Rheum. 2019;49(3):438-445.
- Thorne JE, Suhler E, Skup M, et al. Prevalence of noninfectious uveitis in the United States: a claims-based
analysis. JAMA Ophthalmol. 2016;134(11):1237-1245.