Building on oral immunotherapy research to develop an optimized desensitization approach

We are working to develop treatments for food allergies using our characterized oral desensitization immunotherapy (CODIT™) approach.

 

In developing our CODIT approach, we leveraged extensive independent scientific research demonstrating that food allergy patients can be desensitized to exposure to food allergens by ingesting increasing amounts of the allergen over a period of months. This general method is commonly referred to as oral immunotherapy, or OIT.

Our CODIT approach aims to:

  • precisely control the amount of key allergens
  • establish very gradual treatment regimens that begin with low doses of protein
  • validate those regimens in high-quality, double-blind, placebo-controlled studies

Upon achieving desensitization, a patient would continue to take maintenance doses of the product used in our CODIT approach in order to maintain desensitization.

The goal of our CODIT approach is to desensitize the patient to exposure to the allergens in a food, and thus reduce the likelihood of a severe allergic reaction upon accidental exposure to it.

A Long History of OIT

For more than a century, physicians have investigated OIT to treat patients with food allergies. In 1906, Alfred Schofield, a London physician, began treating a 13-year-old boy for egg allergy by giving him “constant administration of egg,” starting with 1/10,000th of an egg daily and gradually increasing over several months. Schofield reported the success of his treatment in a 1908 paper in The Lancet: “A case of egg poisoning.”

Over the past decade, academic researchers have tested OIT extensively in numerous clinical studies and shown that it can effectively desensitize patients with a range of food allergies. Typically, initial administration of a particular dose of the food is done in an allergist’s office, and subsequent administrations are done at home.

The highest dose level administered has varied depending on the patient and the protocol, but generally the goal has been to reach a level greater than the amount a patient might come into contact with through an accidental exposure. Once the top level is attained, the patient continues with a maintenance dose on a regular basis. If the patient ceases to take the maintenance dose, the desensitization will fade over weeks and months.

The Potential Attributes of our CODIT™ Approach

Despite OIT’s demonstrated ability to treat patients with food allergies, its current use is limited to academic medical centers conducting food allergy research and a few community-based allergy centers. The academic centers often have long waiting lists for their studies, and many patients are unable to access those centers or are not comfortable trying an unapproved treatment option.

In order for the benefits of OIT to become widely available to patients suffering from food allergies, there must be an approved product that provides

  • demonstrated safety and efficacy
  • convenient administration and
  • easy incorporation into a clinician’s practice

We believe an approved, clinically validated CODIT™ approach could achieve greater acceptance than existing OIT approaches.

If patients were to become desensitized using our CODIT approach, they would continue to avoid exposure to their food allergens and continue to carry epinephrine auto-injectors.