Tommy Ritz began injecting himself with insulin when he was 5.
“It was the norm,” he said. “It helped that my dad had been a diabetic since he was 25, so it wasn't too weird to have to give myself injections and prick my finger. By 6 or 7, I was managing it by myself.”
Ritz is a student in the class of 2019 MBA program at William & Mary’s Raymond A. Mason School of Business. He and his father are Type 1 diabetics. They have an idea for a drug designed to alleviate the misery of hyperglycemic episodes that Type 1 diabetics experience many times a week. Jason McDevitt is helping Ritz and his dad take their discovery to market.
McDevitt is William & Mary’s director of technology transfer. He has helped Ritz form a company, Auxulin, and has secured intellectual property rights for the drug, which carries the working title Aux-101.
The idea behind Aux-101 came to Ritz in the winter of 2016 on the day following a hyperglycemic episode that saw his blood sugar soar to 500.
“That's a level that usually requires hospitalization, but I didn't go,” Ritz said. “I drank water and took insulin, enough to get it down over the course of the night. The next day my father and I were at a CVS Pharmacy, and I turned to him and I said, you know, there should be something out there to lower your blood sugar besides insulin."
A deep dive into the literature
His father, a Cleveland podiatrist and registered pharmacist, said, “There probably is.” So the two of them began a search that extended through U.S. patents to drugs in the development pipeline. They made deep, deep dives into academic medical journals and came up empty — but they were able to identify a few potential approaches to a solution.
McDevitt and Ritz are both understandably close-mouthed about details of Aux-101, but share some information. It’s a variation of a prescription drug that is off-patent and not widely used. McDevitt explained that the substance should be classified as a 505(b)(2) drug.
“Technically, this is a new use of an old drug,” McDevitt said. “We're taking an old drug that is off-patent, changing the formulation, and using it for something different. The 505(b)(2) designation refers to the particular code of law that potentially allows you to get a drug to market more quickly.”
Since the drug is available, it means that limited human testing for this new use could begin immediately. The Ritzes tested the drug on themselves when they were having hyperglycemic episodes.
30-60 hyperglycemic episodes a month
Hyperglycemia is defined as a glucose level of 250 mg/dL (milligrams per deciliter of blood) or above. Ritz said he has between 30 to 60 hyperglycemic periods each month. The episodes are of varying severity. He points out that he is healthy for a Type 1 diabetic and keeps a close eye on his levels.
“I exercise every day, and I have a restrictive diet,” Ritz said. “I have a new insulin pump — it has artificial intelligence in it to help regulate my blood sugar. My glucose levels are better controlled than the average diabetic, and I'm still having this happen twice a day. So, if I'm an example of a patient who exhibits good blood glucose management, there's going to be a lot of people for whom this is going to be an even greater issue.”
Type 1 diabetics can become resistant to their injected insulin during hyperglycemic episodes. And Ritz said that the higher the blood sugar level, the more likely the body is to become insulin-resistant. Further, the longer a diabetic is hyperglycemic, the greater their risk of hospitalization and developing dangerous long-term complications.
“Say my blood sugar is 300; I take three units of insulin. The level doesn't move. I take another two; it's not moving,” he said. “Take another one. It's not moving. Finally, it drops after I've taken seven or eight units of insulin over the course of several hours.
“But if I take that initial correction dose of three units along with Aux-101, that's all I need,” Ritz added. In addition to overcoming the body’s insulin resistance, Aux-101 slashes the time it takes for his blood sugar to return to normal: 45 minutes, rather than the two to three hours.
It may reduce insulin usage
In addition to the reduction in time to get blood sugar back to normal, Aux-101 may reduce insulin usage, a potentially important benefit given the rising costs of insulin medications.
Aux-101 is administered orally. As currently formulated, it’s meant only to mitigate the physiological effects of hyperglycemia — not as a replacement for daily insulin maintenance.
Ritz said he and his father established a testing regimen. When their blood sugar was high, they would take an injection of insulin, then check their levels every 15 minutes until it was below 180. To get more accurate readings, they used an actual blood-sugar machine, rather than a constant glucose monitor.
“At this point, it's not like it works 10 percent of the time,” he said. “Every time, it has worked to reduce our blood sugars from a hyperglycemic level to a normal range, sometimes three times faster than just taking insulin alone.”
Ritz said he came to business school at William & Mary in part to take advantage of the business school’s Executive Partners network, to get some guidance in how to take the drug to market and in developing a commercialization strategy.
“I got a lot of good advice, but a lot of people didn't understand it or feel comfortable enough with the science behind it to move forward,” he said. Then one day he was talking with Graham Henshaw, the executive director of the school’s Alan B. Miller Entrepreneurship Center.
“Graham asked me if I had talked to Jason at the tech transfer office,” Ritz recalled. “I said no, so I decided to set up a meeting with him. In our initial conversation, Jason immediately understood the potential, and we just moved forward from there.”
William & Mary’s a stakeholder in Auxulin
William & Mary has invested in Auxulin, providing funding to secure the intellectual property rights as well as for McDevitt’s expertise. As a stakeholder, the university stands to gain financially from the market success of Aux-101.
McDevitt knows a great deal about the arcana of intellectual property laws, and he is familiar with 505(b)(2) drugs, having previously founded a company developing a new use of an old tuberculosis drug. He even used to work in a lab dedicated to Type 2 diabetes. But his dealings with Ritz opened his eyes to the day-to-day life of a Type 1 diabetic.
“I learned that Type 1 diabetics die on average 13 years earlier than the general population,” McDevitt said. “And they have all these health complications that are related to blood sugar management. When they did tests on diabetics and did very careful control of blood sugar, then the risk of these complications drop.”
Aux-101 reduces the duration and severity of hyperglycemic episodes, so McDevitt expects the drug to help reduce some of the complications typical of Type 1 diabetes. One such complication is neuropathy, the nerve damage that causes numbness in diabetics’ extremities and can lead to more serious damage. Another complication is retinopathy — damage to the eyes.
“I expect Aux-101 to deliver these long-term health benefits and reduce hospitalizations among Type 1 diabetics,” McDevitt said. “That’s in addition to the short-term benefits of getting their blood sugar levels down quicker.”
McDevitt and Ritz will take the Auxulin story to the BIO International Convention in Philadelphia. They are scheduling pitch meetings with representatives of pharma-tech firms during the June 3-6 session.
“That's a very big meeting for us because we have really good data,” McDevitt said. “And we're hopeful that someone is going to want to partner with us. If they do, they will be the ones that run with it and bring it to market. If they don't, we will be seeking investors.”