We are committed to improving the lives of people living with autoimmune, inflammatory and allergic diseases

Food Allergy

IgE-mediated food allergy, defined as an adverse immune reaction to food, is a common disorder, estimated to affect approximately 1 in 13 children (7.6%) and 1 in 10 adults (10.8%), equating to more than 33 million people in the United States. 40% of children and 46% of adults are allergic to multiple foods. Symptoms of IgE-mediated food allergy typically occur within minutes to hours after allergen exposure and may involve multiple organ systems including the skin, respiratory, gastrointestinal, cardiovascular and neurological systems. Common symptoms include hives (urticaria), skin swelling (angioedema), wheezing, nausea and vomiting, while severe reactions like anaphylaxis involve systemic symptoms such as respiratory compromise and cardiovascular collapse. Beyond the risk of acute anaphylaxis, food allergy imposes a substantial burden on patients and caregivers, requiring constant vigilance, strict dietary avoidance and ongoing anxiety around accidental exposure.

Despite the prevalence and severity of food allergies, there remains no cure and few treatments have been approved. The current standard of care in food allergy is strict avoidance of the allergen with the use of epinephrine for accidental exposure. This approach has been shown to be insufficient, with 40% of children and 50% of adults with food allergies experiencing a severe reaction due to accidental ingestion. Oral immunotherapy (OIT) is designed to desensitize patients through repeated exposure to allergens but requires time-consuming office visits and the daily consumption of allergenic foods, which can be associated with dose-related adverse events including anaphylaxis.

More recently, IgE-blocking therapy has emerged as a novel treatment option for food allergy. In February 2024, Xolair became the first medication to be approved by the FDA to help reduce allergic reactions to multiple foods after accidental exposure. Despite clinical benefit, IgE-blocking approaches may be constrained by body weight and IgE-dependent dosing requirements, administration burden and failure to achieve sufficient IgE suppression in certain patients.

Graves’ Disease

Graves’ disease is an autoimmune disorder in which the immune system mistakenly attacks the thyroid, causing the thyroid to become enlarged and overactive. It is the most common cause of hyperthyroidism globally and is estimated to affect 2% of women and 0.2% of men, which is approximately 3 million adults in the United States. The increased activity of the thyroid is caused by the presence of thyroid-stimulating hormone receptor (TSHR) autoantibodies (also known as thyrotropin receptor antibodies or TRAbs). These autoantibodies activate the thyroid-stimulating hormone receptor and induce thyroid cells to secrete excess thyroid hormones such as triiodothyronine (T3) and thyroxine (T4). Higher levels of TRAbs are associated with more severe disease.

Because thyroid hormone affects many systems in the body, Graves’ disease can cause a wide range of symptoms affecting the heart, bones, muscles and metabolism, which can have a significant impact on quality of life. People living with Graves’ disease experience multiple symptoms resulting from hyperthyroidism or from the underlying autoimmunity, including, but not limited to, weight loss, heat intolerance, tremor and palpitations. Up to 50% of patients with Graves’ disease develop thyroid eye disease (TED), which affects the muscles and tissues around the eyes. Severe cases of Graves’ disease, known as “thyroid storm,” are characterized by extremely elevated thyroid hormone levels, blood pressure instability and a high rate of mortality.

Graves’ disease is typically managed with antithyroid drugs (ATDs), radioiodine ablation (RAI) or thyroidectomy (surgical removal of the thyroid). While ATDs can alleviate symptoms, they do not address the underlying autoimmune pathology driving the disease and are associated with safety and tolerability concerns. As a result, clinical outcomes are often suboptimal, with remission achieved in only approximately 45% of patients and relapse rates as high as 52% reported in meta-analyses, highlighting the need for improved treatment options. For patients who fail or are intolerant of ATDs, treatment often involves radioiodine ablation or surgical thyroidectomy. These approaches are invasive and result in permanent destruction or removal of thyroid tissue, frequently leading to hypothyroidism and the need for lifelong thyroid hormone replacement therapy.