The incidence of allergic disease such as asthma, rhinitis, atopic dermatitis, and food allergies has increased to epidemic proportions in both the developed and developing worlds. Currently 40% of the US population is allergic to one or more common inhalant or food allergens and half of those will be symptomatic at any one time. With a nearly four-fold increase in allergic disease between 1979 and 1992, it is not surprising that childhood asthma is the largest cause of school absenteeism. In total, there are 45 million asthma patients in the US, Europe and Japan currently consuming over $13 BB in prescription drugs, a market that is expected to grow 15% annually through 2016. While the prescription market is dominated by oral and inhaled steroids and leukotriene antagonists, newer therapeutics, including biologicals are expected to increase from 5% to 12% of the market during this time frame. Indeed, sales of Xolair®, an anti-IgE antibody and the first biological to be approved for asthma, were $500 MM in 2007 and expected to top $1 BB in 2013.

The size of the problem of food allergy has only recently undergone careful scrutiny and it was found to affect about 3.5% of the overall US population and 7% of young children. Peanut allergy, the most common and notorious food allergen, affects 1% of the US adult population and 1.8% of 4-5 year olds in the UK. Although symptoms of many allergic disorders can be suppressed by pharmacologic interventions, such interventions do not provide for sustained remission or cure. Paradoxically, despite the expanding repertoire of medications, at the same time there has been a well-publicized increase in the morbidity and mortality from these allergic diseases. This has been particularly dramatic for severe food allergy where there is no effective therapy other then attempted strict avoidance and emergency epinephrine if and when a severe and potentially life threatening reaction occurs. Sales of emergency epinephrine injections kits (EpiPen®) have exceeded $200 MM annually due in part to the fact that 14% of school aged children accidentally ingest a food allergen to which they are sensitized each year.

Allergen injections (allergy immunotherapy) can be effective in inhalant allergy (allergic rhinitis/hay fever) and asthma but this modality is time consuming, extending over a protracted course of years and has a poor therapeutic index due to the common occurrence of mild to moderate and occasional severe adverse reactions. For food allergy, conventional allergy immunotherapy is simply too dangerous to be undertaken and an effective intervention is desperately needed. Thus the allergic disorders that are the target of Tunitas’ therapeutics are (1) common and even increasing, (2) associated with enormous direct costs and (3) represent a major area of unmet need for interventions designed to provide overarching treatment or cure.