An estimated 32 million Americans have food allergies, with peanut and tree nuts taking the two top spots amongst the most severe food allergy reactions. Medical procedures to treat anaphylaxis — (a severe allergic reaction) increased 380 percent between 2007 and 2016, according to the Food Allergy Research & Education.
“Food allergy therapy is still in its infancy. Currently, the patient is introduced to the food they’re allergic to, in a controlled environment, to increase allergen desensitization over time,” Patel explains.
His biotech startup, Moonlight Therapeutics, aims to improve treatment outcomes with a proprietary skin patch that delivers tiny amounts of allergens to the skin’s immune cells through microneedles.
“The interesting thing in this particular field is that your medicine — the treatment — is what you’re allergic to,” says Patel, who serves as CEO of the startup.
“Our first patch will address peanut allergies. In this case, the patch delivers the peanut protein in small doses. You’re essentially training your immune system over increased dosages to learn that this is not something it should be reacting to.”
The technology was created by Harvinder Gill, a Ph.D. at Texas Tech University, when he saw how inefficient current patch solutions are. Competitors were trying to deliver the proteins through the top layer of the skin, similar to a nicotine patch.
Patel likens it to “trying to drive a large truck through a toll booth that’s designed for a bicycle.”
“Your skin is designed to keep things out, especially large things like proteins that aren’t supposed to get in. Unless there’s some damage to the skin, the likelihood of the proteins getting through is very low,” he says.
Patel shares that those patches must remain on the skin for 24 hours a day and be replaced every single day. But children often accidentally remove the patch or get it wet.
Patel, Gill and Vladimir Zarnitsyn joined forces to commercialize Gill’s technology.
Moonlight’s TASIS is a small skin patch that delivers the peanut protein treatment in less than five minutes through microneedles and is then removed.
The patch gets the protein right under the skin to the immune cells, without the risk of entering the bloodstream.
The microneedles are dry coated with the protein. The skin’s moisture actually dissolves the coating of the needles, delivering the protein to the cells.
The product will be distributed to patients through an allergist, like any other prescription treatment. The physician keeps track of the patient’s progress and increases the dosage as needed until the patient achieves a safe desensitization.
The team hopes to expand beyond peanuts in the future, as the technology can work for any foodborne allergen.
Moonlight Therapeutics recently received a $2.5 million grant from the National Institute of Allergy and Infectious Diseases, a division of the NIH. Patel says this will help them go into production fully and support their pre-clinical development and upcoming trials.