Systemic lupus erythematosus (SLE), or lupus, is an insidious disease that affects about 1.5 million Americans and approximately 5 million worldwide, according to the Lupus Foundation of America. The most severe form of this condition is particularly dreadful, especially for women. On a day-to-day basis, they are faced with the symptoms of this autoimmune disease that attacks healthy tissues—potentially including skin, joints, the brain, kidneys and blood vessels.
We’ve talked about the physical, emotional and social manifestations of lupus on patients here before, including our commitment toward developing novel therapeutics. Our efforts have included conducting important trials on two potential drugs, sifalimumab and anifrolumab. Last year, the culmination of Phase II trials on the two monoclonal antibodies (mAbs) revealed encouraging data on how these drugs may help to improve the lives of patients with lupus.
Progressing to Phase III with anifrolumab
Now, we have progressed what we believe is the most promising of these two therapies—anifrolumab—into Phase III. We’re calling this the TULIP (Treatment of Uncontrolled Lupus via Interferon Pathway) program. The decision to focus our efforts on anifrolumab was driven by the data from these Phase 2 trials, which showed that this specific mAb may have potential for treating the debilitating symptoms of moderate to severe lupus, safely and with the best probability for sustainable benefits.
This is exciting for us because it offers hope to patients with lupus, who have seen only one new drug on the market in the last six decades. During this trial, our investigators will evaluate the safety and efficacy of anifrolumab versus a placebo in patients with moderately to severely active, autoantibody-positive lupus, while they are receiving the standard of care (SOC) treatment. SOC treatments include oral corticosteroids, immunosuppressants and anti-malarials, all of which can have challenging and, often nasty, side effects. So, in addition to assessing how anifrolumab may reduce disease activity and its accompanying flare-ups, part of our therapeutic goal is to be able to offer an option that limits the need for these SOC drugs.
Unique anti-Type 1 IFN receptor approach
Why anifrolumab is so important is exciting as well. The molecule is the only anti-Type I interferon (IFN) receptor approach currently in development for lupus. What we know about the IFN pathway is that it strongly correlates with increased disease activity in patients with lupus. Because anifrolumab targets the interferon receptor, it is able to block all Type 1 interferons, not just interferon-alpha, which is where most of the science has been focused.
Also noteworthy about the anifrolumab trial for lupus is that we’ll be looking at a potential companion or complementary diagnostic—a biomarker test that is based on the Type 1 IFN-inducible gene signature. What this offers is the ability to identify the patients who will more likely to have an enhanced response to this treatment.
Too many years have passed without significant new treatment options for this terrible disease. Our goal is to ultimately deliver something that is potentially life changing for patients with a lupus diagnosis. We believe anifrolumab with its unique anti-Type 1 IFN receptor approach offers that hope and puts us on the right track.