“I knew something was terribly wrong. I called 911, then ran to the porch to wait for an ambulance. Within seconds, I was lying flat on the wood porch, struggling against my ever-shallowing breath. And then … I wasn’t breathing anymore. I was in full respiratory arrest.”

This is how Wendy, then a 19-year-old college student, describes the anaphylaxis she experienced after taking a bite of cheesecake that had had crushed peanuts on its surface.

Wendy survived. But around the world, hundreds die from peanut allergies each year, and countless more come close. Severe reactions from consuming peanuts are all too common, each bringing the horror that Wendy experienced.

It’s this kind of horror that Moonlight Therapeutics is trying to stave off – for good.

Launched by founders out of Georgia Tech with early investment from GRA, Moonlight has come up with a new way for the body to defend itself from life-threatening peanut allergies. It’s a thumb-sized stamp, stippled with needles less than half the thickness of a quarter – so small, they cause no pain.

Press this stamp into your arm, keep it there a few minutes, and you’ve introduced a micro-dose of allergen to your body. Repeat this step over time, and your body is eventually desensitized to the very threat that once could have killed you.

The simple stamp is actually a complex drug delivery system, named MOON101, to treat peanut allergy. It now has a clear path to testing and evaluation: In July 2023, Moonlight got word of an NIH grant to fund the steps needed for Phase 1 clinical trials.

Why peanuts?
A 2021 NIH white paper reports that “peanut allergy [has] increased 3.5-fold over the past two decades” in the U.S. and Europe. As much as 2% of the population in the western world has this allergy; of those who do, as many as 14% are accidentally exposed to peanuts every year.

Allergic reactions to peanuts can be fended off with available emergency medications, like the epi pen. But what if these reactions could be prevented from occurring in the first place? That’s what Samir Patel and colleague Harvinder Gill wanted to know.

There’s a back story.
While in graduate school in 2008, Patel worked in the lab of Mark Prausnitz, who was advancing development of microneedle technology. (Prausnitz’s company, Micron Biomedical, is in clinical trials for vaccines that are delivered by microneedles that dissolve into the skin.) In one project, Patel was trying to use a microneedle device to introduce a drug to the sclera, the white outer portion of the eye.

“But I couldn’t get it to happen,” he says. “I ended up going through that layer and injecting between the sclera and the layer just beneath it.”

That accident turned out to be a breakthrough. Patel eventually realized he had accessed the suprachoroidal space in the eye, an area that could allow medication to flow between layers of the eye. With his misstep, a new frontier of eye treatment had opened up.

Patel and another colleague, Vladimir Zarnitsyn, launched a startup, Clearside Biomedical, which has found success delivering therapeutics to the suprachoroidal space. Both eventually exited Clearside and returned to the lab to pursue new answers to human needs.

Then came Moonlight
In early January 2017, Patel called Harvinder Gill, a former colleague at Georgia Tech, now a professor at Texas Tech, to catch up. “He had started working with microneedles to find a way to treat allergies,” Patel recalls.

At first, the focus was on using microneedles to combat seasonal allergies. But then the two started talking about a much harsher threat – food allergies.

“At the time, there were no FDA-approved treatments for food allergies, and no one is concerned about dying from seasonal allergies,” Patel says.

A company was born.

How MOON101 works
The microneedles on Moonlight’s stamp are coated with an ultra-tiny dose of peanut protein, and the needles themselves are engineered to deliver the allergen to the outermost layer of the dermis.

Their target is the skin’s immune cells, which are found mostly in this area of the skin. Deliver the allergen there, they reasoned, and it would engage the immune cells, kind of like a skirmish in a larger war. Over time, these skirmishes would be less and less intense, as both sides got to know each other better. Eventually, the body’s immune system would be trained to react much less vigorously to the allergen.

Already, that thinking has been validated in animal models. Moonlight is now working on its Investigational New Drug application, and safety testing in humans is planned to begin in 2024.

Moonlight’s advantage
A different kind of “desensitizing” approach from a company called DBV Technologies has had some promising results for kids with peanut allergies. Currently in late-stage development under the name Viaskin, it’s a patch that’s applied to the back, between the shoulder blades, and worn for months. It uses no microneedles – rather, its approach is more like a Band-AidTM, and its formula interacts with the surface of the skin.

Viaskin has yet to demonstrate a significantly strong response in children over the age of 3. But in May 2023, the company announced that Viaskin showed promise in Phase 3 clinical trials for toddlers. Children aged 1 to 3 who wore the patch for a year were more desensitized to peanut allergy than children in a placebo group.

Moonlight’s stamp, however, is believed to control dosing much better – it delivers the allergen to where the immune cells are more abundant and overcomes skin barrier properties. Because it’s applied daily for just a few minutes, it’s easy to monitor. By contrast, the Viaskin patch, which has to be worn 24 hours a day, faces the obstacle of falling off unnoticed, thus interrupting its work.

Moreover, the MOON101 needles are hardly needles at all. “When you apply the stamp, you feel kind of a tingling, as you would if you’d pressed the rougher part of a Velcro strap onto your skin,” Patel says. “So we believe a stamp that’s applied for just a few minutes is much less of an obstacle to being used consistently.”

The other advantage: Fewer side effects
The FDA has approved just one treatment for peanut allergy. It’s an oral treatment called PalforziaTM, which can bring stomach pain, vomiting and other gastrointestinal side effects along with a significant risk of anaphylactic reaction. Patel says the risks are hardly surprising, since patients are eating the very thing they’re allergic to.

“These side effects and treatment regimen have some bearing on the overall burden of the treatment itself,” Patel says. “Patients have to go through nearly a year of up-dosing, meaning they increase dosages every other week in a doctor’s office. During this time, many experience GI system reactions. If the side effects are too severe, they have to step down in the dose, which prolongs the up-dosing. It can be a lot of fine-tuning.”

He adds: “We think the risk and tolerability of MOON101, and the lack of prolonged up-dosing, will make it a product with less burden on both the patient and the family. We don’t expect patients to have to visit the clinic every two weeks to adjust the dose.”

Moon on the horizon
Since its founding, Moonlight Therapeutics has attracted more than $5 million in non-dilutive funding, and the company seeks additional private funds to speed data collection and further develop MOON101. Next year’s clinical trial will be conducted at several of the nation’s top food allergy centers.

“There are over 6 million individuals in the United States alone with a peanut allergy,” says Brian Vickery, director of the Food Allergy Center at Emory and Children’s Healthcare of Atlanta and the lead clinical investigator on the upcoming trial. “With only one FDA-approved therapy, there is still a large unmet need for patients and their families.”

Moonlight aims to fill that need.